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Figure.  CONSORT Flow Diagram of Participants
CONSORT Flow Diagram of Participants
Table 1.  Baseline Characteristics of Participants by Treatment Allocation
Baseline Characteristics of Participants by Treatment Allocation
Table 2.  Child Behavior Outcomes
Child Behavior Outcomes
Table 3.  Remaining Secondary Outcomes: Caregiver-Reported Parenting and Mental Health
Remaining Secondary Outcomes: Caregiver-Reported Parenting and Mental Health
1.
Sadler  K, Vizard  T, Ford  T,  et al.  Mental Health of Children and Young People in England, 2017. Government Statistical Service; 2018.
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Scott  S. Oppositional and conduct disorders. In: Thapar A, Pine DS, Lockman JF, Scott S, Snowling MJ, Taylor E, eds.  Rutter’s Child and Adolescent Psychiatry. 6th ed. Vol 6. John Wiley & Sons Ltd; 2015:966–980. doi:10.1002/9781118381953.ch65
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Caspi  A, Begg  D, Dickson  N,  et al.  Personality differences predict health-risk behaviors in young adulthood: evidence from a longitudinal study.   J Pers Soc Psychol. 1997;73(5):1052-1063. doi:10.1037/0022-3514.73.5.1052 PubMedGoogle ScholarCrossref
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Fergusson  DM, Horwood  LJ, Ridder  EM.  Show me the child at seven: the consequences of conduct problems in childhood for psychosocial functioning in adulthood.   J Child Psychol Psychiatry. 2005;46(8):837-849. doi:10.1111/j.1469-7610.2004.00387.x PubMedGoogle ScholarCrossref
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Gutman  LM, Joshi  H, Khan  L, Schoon  I. Children of the millennium: understanding the course of conduct problems during childhood. UCL Discovery website. Published 2018. Accessed January 20, 2019. https://discovery.ucl.ac.uk/id/eprint/10062657/
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Petitclerc  A, Tremblay  RE.  Childhood disruptive behaviour disorders: review of their origin, development, and prevention.   Can J Psychiatry. 2009;54(4):222-231. doi:10.1177/070674370905400403 PubMedGoogle ScholarCrossref
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Miner  JL, Clarke-Stewart  KA.  Trajectories of externalizing behavior from age 2 to age 9: relations with gender, temperament, ethnicity, parenting, and rater.   Dev Psychol. 2008;44(3):771-786. doi:10.1037/0012-1649.44.3.771 PubMedGoogle ScholarCrossref
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Gardner  F, Leijten  P, Melendez-Torres  GJ,  et al.  The earlier the better? individual participant data and traditional meta-analysis of age effects of parenting interventions.   Child Dev. 2019;90(1):7-19. doi:10.1111/cdev.13138 PubMedGoogle ScholarCrossref
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Mingebach  T, Kamp-Becker  I, Christiansen  H, Weber  L.  Meta-meta-analysis on the effectiveness of parent-based interventions for the treatment of child externalizing behavior problems.   PLoS One. 2018;13(9):e0202855. doi:10.1371/journal.pone.0202855 PubMedGoogle Scholar
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Doyle  O, Harmon  CP, Heckman  JJ, Tremblay  RE.  Investing in early human development: timing and economic efficiency.   Econ Hum Biol. 2009;7(1):1-6. doi:10.1016/j.ehb.2009.01.002 PubMedGoogle ScholarCrossref
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Maughan  B, Barker  ED.  The earlier the better? pausing for thought….   Child Dev. 2019;90(1):20-24. doi:10.1111/cdev.13168 PubMedGoogle ScholarCrossref
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Bagner  DM, Coxe  S, Hungerford  GM,  et al.  Behavioral parent training in infancy: a window of opportunity for high-risk families.   J Abnorm Child Psychol. 2016;44(5):901-912. doi:10.1007/s10802-015-0089-5 PubMedGoogle ScholarCrossref
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Hentges  RF, Weaver Krug  CM, Shaw  DS, Wilson  MN, Dishion  TJ, Lemery-Chalfant  K.  The long-term indirect effect of the early family check-up intervention on adolescent internalizing and externalizing symptoms via inhibitory control.   Dev Psychopathol. 2020;32(4):1544-1554. doi:10.1017/S0954579419001482 PubMedGoogle ScholarCrossref
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Perrin  EC, Sheldrick  RC, McMenamy  JM, Henson  BS, Carter  AS.  Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial.   JAMA Pediatr. 2014;168(1):16-24. doi:10.1001/jamapediatrics.2013.2919 PubMedGoogle ScholarCrossref
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Feinberg  ME, Jones  DE, Roettger  ME, Solmeyer  A, Hostetler  ML.  Long-term follow-up of a randomized trial of family foundations: effects on children’s emotional, behavioral, and school adjustment.   J Fam Psychol. 2014;28(6):821-831. doi:10.1037/fam0000037 PubMedGoogle ScholarCrossref
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Juffer  F, Bakermans-Kranenburg  MJ, van IJzendoorn  MH.  Pairing attachment theory and social learning theory in video-feedback intervention to promote positive parenting.   Curr Opin Psychol. 2017;15:189-194. doi:10.1016/j.copsyc.2017.03.012 PubMedGoogle ScholarCrossref
17.
Ramchandani  PG, O’Farrelly  C, Babalis  D,  et al.  Preventing enduring behavioural problems in young children through early psychological intervention (Healthy Start, Happy Start): study protocol for a randomized controlled trial.   Trials. 2017;18(1):543. doi:10.1186/s13063-017-2293-9 PubMedGoogle ScholarCrossref
18.
Goodman  R.  The Strengths and Difficulties Questionnaire: a research note.   J Child Psychol Psychiatry. 1997;38(5):581-586. doi:10.1111/j.1469-7610.1997.tb01545.x PubMedGoogle ScholarCrossref
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Juffer  F, Bakermans-Kranenburg  M, van IJzendoorn  M.  Manual VIPP-SD: Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline. Centre for Child and Family Studies, Leiden University; 2008.
20.
Bakermans-Kranenburg  M, Juffer  F, Van IJzendoorn  M.  Reflections on the Mirror: On Video-Feedback to Promote Positive Parenting and Infant Mental Health. Guilford Press; 2018.
21.
Sonuga-Barke  EJ, Lamparelli  M, Stevenson  J, Thompson  M, Henry  A.  Behaviour problems and pre-school intellectual attainment: the associations of hyperactivity and conduct problems.   J Child Psychol Psychiatry. 1994;35(5):949-960. doi:10.1111/j.1469-7610.1994.tb02304.x PubMedGoogle ScholarCrossref
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Costello  EJ, Egger  H, Angold  A.  10-Year research update review: the epidemiology of child and adolescent psychiatric disorders, I: methods and public health burden.   J Am Acad Child Adolesc Psychiatry. 2005;44(10):972-986. doi:10.1097/01.chi.0000172552.41596.6f PubMedGoogle ScholarCrossref
23.
Scott  S.  Deciding whether interventions for antisocial behaviour work: principles of outcome assessment, and practice in a multicentre trial.   Eur Child Adolesc Psychiatry. 2001;10(1)(suppl 1):I59-I70. doi:10.1007/s007870170007 PubMedGoogle ScholarCrossref
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Dalen  L, Sonuga-Barke  EJ, Hall  M, Remington  B.  Inhibitory deficits, delay aversion and preschool AD/HD: implications for the dual pathway model.   Neural Plast. 2004;11(1-2):1-11. doi:10.1155/NP.2004.1 PubMedGoogle ScholarCrossref
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Daley  D, O’Brien  M.  A small-scale randomized controlled trial of the self-help version of the New Forest Parent Training Programme for children with ADHD symptoms.   Eur Child Adolesc Psychiatry. 2013;22(9):543-552. doi:10.1007/s00787-013-0396-8 PubMedGoogle ScholarCrossref
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Gardner  FE, Sonuga-Barke  EJ, Sayal  K.  Parents anticipating misbehaviour: an observational study of strategies parents use to prevent conflict with behaviour problem children.   J Child Psychol Psychiatry. 1999;40(8):1185-1196. doi:10.1111/1469-7610.00535 PubMedGoogle ScholarCrossref
27.
Sonuga-Barke  EJ, Thompson  M, Daley  D, Laver-Bradbury  C.  Parent training for attention deficit/hyperactivity disorder: is it as effective when delivered as routine rather than as specialist care?   Br J Clin Psychol. 2004;43(pt 4):449-457. doi:10.1348/0144665042388973 PubMedGoogle ScholarCrossref
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Achenbach  TM, Rescorla  L.  Manual for the ASEBA School-Age Forms & Profiles: An Integrated System of Multi-informant Assessment. ASEBA; 2001.
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National Collaborating Centre for Mental Health. Antisocial Behaviour and Conduct Disorders in Children and Young People: The NICE Guideline on Recognition, Intervention and Management. The British Psychological Society & The Royal College of Psychiatrists; 2013.
30.
D’Amico  F, Knapp  M, Beecham  J, Sandberg  S, Taylor  E, Sayal  K.  Use of services and associated costs for young adults with childhood hyperactivity/conduct problems: 20-year follow-up.   Br J Psychiatry. 2014;204(6):441-447. doi:10.1192/bjp.bp.113.131367 PubMedGoogle ScholarCrossref
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Olazagasti  MAR, Klein  RG, Mannuzza  S,  et al. Does childhood attention-deficit/hyperactivity disorder predict risk-taking and medical illnesses in adulthood?  J Am Acad Child Adolesc Psychiatry. 2013;52(2):153-162. doi:10.1016/j.jaac.2012.11.012
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Daley  D, Van der Oord  S, Ferrin  M,  et al. Behavioral interventions in attention-deficit/hyperactivity disorder: a meta-analysis of randomized controlled trials across multiple outcome domains.  J Am Acad Child Adolesc Psychiatry. 2014;53(8):835-847. doi:10.1016/j.jaac.2014.05.013
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Cottrell  DJ, Wright-Hughes  A, Collinson  M,  et al.  Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial.   Lancet Psychiatry. 2018;5(3):203-216. doi:10.1016/S2215-0366(18)30058-0 PubMedGoogle ScholarCrossref
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Goodyer  IM, Reynolds  S, Barrett  B,  et al.  Cognitive behavioural therapy and short-term psychoanalytical psychotherapy versus a brief psychosocial intervention in adolescents with unipolar major depressive disorder (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled superiority trial.   Lancet Psychiatry. 2017;4(2):109-119. doi:10.1016/S2215-0366(16)30378-9 PubMedGoogle ScholarCrossref
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Robling  M, Bekkers  M-J, Bell  K,  et al.  Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.   Lancet. 2016;387(10014):146-155. doi:10.1016/S0140-6736(15)00392-X PubMedGoogle ScholarCrossref
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Bick  J, Dozier  M.  The effectiveness of an attachment-based intervention in promoting foster mothers’ sensitivity toward foster infants.   Infant Ment Health J. 2013;34(2):95-103. doi:10.1002/imhj.21373 PubMedGoogle ScholarCrossref
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Roben  CKP, Dozier  M, Caron  EB, Bernard  K.  Moving an evidence-based parenting program into the community.   Child Dev. 2017;88(5):1447-1452. doi:10.1111/cdev.12898 PubMedGoogle ScholarCrossref
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Doyle  O, Delaney  L, O’Farrelly  C, Fitzpatrick  N, Daly  M.  Can early intervention improve maternal well-being? evidence from a randomized controlled trial.   PLoS One. 2017;12(1):e0169829. doi:10.1371/journal.pone.0169829 PubMedGoogle Scholar
39.
Allen  G.  Early Intervention: The Next Steps. Cabinet Office and Department for Work and Pensions; 2011.
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Black  MM, Walker  SP, Fernald  LCH,  et al; Lancet Early Childhood Development Series Steering Committee.  Early childhood development coming of age: science through the life course.   Lancet. 2017;389(10064):77-90. doi:10.1016/S0140-6736(16)31389-7 PubMedGoogle ScholarCrossref
41.
Department of Health and Social Care; Department for Education.  Transforming Children and Young People’s Mental Health Provision: A Green Paper. Department of Health and Department for Education; 2017.
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    Original Investigation
    March 15, 2021

    A Brief Home-Based Parenting Intervention to Reduce Behavior Problems in Young Children: A Pragmatic Randomized Clinical Trial

    Author Affiliations
    • 1Division of Psychiatry, Imperial College London, London, United Kingdom
    • 2Play in Education, Development, and Learning (PEDAL) Research Centre, Faculty of Education, University of Cambridge, Cambridge, United Kingdom
    • 3School of Public Health, Imperial College London, London, United Kingdom
    • 4Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom
    • 5Clinical Child and Family Studies, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
    • 6Institute of Psychology, Psychiatry, and Neuroscience, King’s College London, London, United Kingdom
    • 7School of Psychology, University of Surrey, Guildford, United Kingdom
    • 8Parent Supporter Service, Netmums, London, United Kingdom
    • 9Department of Psychiatry, University of Oxford, Oxford, United Kingdom
    • 10African Health Research Institute, Durban, South Africa
    • 11Department of Psychology, Education, and Child Studies, Erasmus University Rotterdam, Rotterdam, the Netherlands
    • 12Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom
    JAMA Pediatr. 2021;175(6):567-576. doi:10.1001/jamapediatrics.2020.6834
    Key Points

    Question  Does a brief video-feedback parenting intervention delivered in a routine health context improve behavior outcomes for at-risk children aged 12 to 36 months?

    Findings  This randomized clinical trial that included 300 children and their caregivers found lower levels of behavior problems among families allocated to receive the intervention vs those who received usual care. In particular, conduct problems decreased.

    Meaning  This brief parenting intervention can benefit the mental health of very young children and can be delivered by frontline staff in a routine community health service setting.

    Abstract

    Importance  Behavior problems are one of the most common mental health disorders in childhood and can undermine children’s health, education, and employment outcomes into adulthood. There are few effective interventions for early childhood.

    Objective  To test the clinical effectiveness of a brief parenting intervention, the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD), in reducing behavior problems in children aged 12 to 36 months.

    Design, Setting, and Participants  The Healthy Start, Happy Start study was a 2-group, parallel-group, researcher-blind, multisite randomized clinical trial conducted via health visiting services in 6 National Health Service trusts in England. Baseline and 5-month follow-up data were collected between July 30, 2015, and April 27, 2018. Of 818 eligible families, 227 declined to participate, and 300 were randomized into the trial. Target participants were caregivers of children who scored in the top 20% for behavior problems on the Strengths and Difficulties Questionnaire. Participants were randomly allocated on a 1:1 basis to receive either VIPP-SD (n = 151) or usual care (n = 149), stratified by site and number of participating caregivers. Analysis was performed on an intention-to-treat basis. Statistical analysis was performed from September 5, 2019, to January 17, 2020.

    Interventions  All families continued to access usual care. Families allocated to VIPP-SD were offered 6 home-based video-feedback sessions of 1 to 2 hours’ duration every 2 weeks.

    Main Outcomes and Measures  The primary outcome was the score on an early childhood version of the Preschool Parental Account of Children’s Symptoms, a semistructured interview of behavior symptoms, at 5 months after randomization. Secondary outcomes included caregiver-reported behavior problems on the Child Behavior Checklist and the Strengths and Difficulties Questionnaire.

    Results  Among 300 participating children (163 boys [54%]; mean [SD] age, 23.0 [6.7] months), primary outcome data were available for 140 of 151 VIPP-SD participants (93%) and 146 of 149 usual care participants (98%). There was a mean difference in the total Preschool Parental Account of Children’s Symptoms score of 2.03 (95% CI, 0.06-4.01; P = .04; Cohen d = 0.20 [95% CI, 0.01-0.40]) between trial groups, with fewer behavior problems in the VIPP-SD group, particularly conduct symptoms (mean difference, 1.61 [95% CI, 0.44-2.78]; P = .007; d = 0.30 [95% CI, 0.08-0.51]). Other child behavior outcomes showed similar evidence favoring VIPP-SD. No treatment or trial-related adverse events were reported.

    Conclusions and Relevance  This study found that VIPP-SD was effective in reducing symptoms of early behavior problems in young children when delivered in a routine health service context.

    Trial Registration  isrctn.org Identifier: ISRCTN58327365

    Introduction

    Behavior problems are one of the most common mental health disorders in childhood, affecting 5% to 10% of children.1,2 Children with enduring behavior problems are at risk of poorer health, social, and educational outcomes across the life course, causing distress to families and generating large costs for society.2-6

    A key risk factor for behavior problems is the parental care that children receive.7 Parenting interventions are effective in reducing behavior problems; however, most programs target preschool-aged and school-aged children.8,9 Intervening earlier in childhood could be more effective from a clinical, economic, and educational perspective because there is greater opportunity to intercept psychopathologic symptoms before they become embedded.10 However, to our knowledge, relatively few interventions have targeted behavior problems at their onset in 1- and 2-year-old children, particularly in routine health services.8,11 Notable exceptions support the feasibility and efficacy of parent training for families of infants in the home12,13 and the effectiveness of group parent training for 2- to 4-year-old children in health care settings.14 There is also some support for the long-term benefits of early interventions on behavior outcomes.13,15

    This study aimed to test the effectiveness of a brief parenting intervention in preventing behavior problems in at-risk children as compared with usual care (UC). Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) targets parents’ sensitivity and sensitive discipline and is suitable for children as young as 12 months. It has an established evidence base from 12 randomized clinical trials (RCTs) for caregivers’ sensitivity (combined effect size, Cohen d = 0.47) and children’s behavior problems (7 trials; d = 0.26).16 However, VIPP-SD has yet to be tested in a routine health service, to our knowledge.

    The primary hypothesis was that, among children aged 12 to 36 months with high levels of behavior problems, adding a brief video-feedback intervention to UC would reduce behavior problems, measured by a clinical interview at 5 months after randomization. We also hypothesized that the intervention would reduce behavior problems as measured by caregiver-reported questionnaires.

    Methods
    Study Design, Setting, and Participants

    Healthy Start, Happy Start was a 2-group, parallel-group, researcher-blind, multisite RCT.17 The protocol was approved by a National Health Service (NHS) Ethics Committee and is available with the statistical analysis plan in Supplement 1. Parents or caregivers provided written informed consent. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

    Recruitment via 6 NHS trusts in the UK involved a screening stage followed by a trial stage. Recruitment to the screening stage was through face-to-face or postal contacts in health visiting services, supplemented by advertisements in other clinical and community services and online outlets. Screening identified families whose children scored in the top 20% for behavior problems (≥8 on the externalizing subscale) on the Strengths and Difficulties Questionnaire (SDQ)18 based on the 2- to 4-year-old norming sample (R. Goodman, PhD, email, May 7, 2015). Caregivers whose children met eligibility owing to their SDQ score were contacted via telephone to determine the family’s full eligibility and interest in the trial. One or 2 caregivers could participate.

    Families were included if the parent(s) or caregiver(s) were older than 18 years and provided written informed consent and the child was aged 12 to 36 months and scored in the top 20% for externalizing behaviors on the SDQ. Families were excluded if the child or parent had a sensory impairment, learning disability, or language limitation that precluded their participation; if a sibling was already participating in the study; or if the family was participating in another closely related research trial, receiving an individualized video-feedback intervention, and/or participating in active court proceedings. Recruitment took place between July 30, 2015, and July 26, 2017. Posttreatment assessments took place between December 9, 2015, and April 27, 2018.

    Randomization

    Research assistants enrolled participants on the study electronic data capture system. Participants were randomly allocated on a 1:1 basis to receive VIPP-SD or UC, stratified by recruitment site and willingness and availability of caregivers (1 vs 2) to participate. The randomization list, prepared by an independent statistician using varying block sizes (of 2, 4, and 6), was uploaded to the electronic data capture system, and participants were allocated to the next available treatment code in the appropriate list. The allocation sequence was not accessible to the trial manager, chief investigator, or clinical supervisors. Research assistants who conducted assessments were blinded to treatment allocation, and clinical staff who delivered the intervention did not conduct assessments.

    Intervention Description

    Families in the VIPP-SD group were offered 6 home-based sessions of 1- to 2-hour duration every 2 weeks by a trained health professional. Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline is a manualized intervention based on attachment and social learning theories.16,19 During 4 core and 2 booster sessions, the intervener films parents interacting with their child (approximately 10 minutes) during play-based and challenging interactions and then provides focused feedback on the filmed interactions from the previous visit.20 Treatment fidelity was monitored through regular clinical supervision, and visits were audio recorded to allow a random sample (10%) to be rated for fidelity.

    Interveners were trained health professionals, predominantly public health nurses and nursery nurses, as well as a small number of professionals from therapy, psychology, and psychiatry backgrounds. Interveners completed 4 days of VIPP-SD training and 3 supervised practice sessions. Participants were allocated to the next available local intervener.

    Usual Care

    Participants in both groups continued to receive UC, which was typically minimal (there are no standard care pathways in the NHS for early-onset behavior problems). Some participants received support and advice from a health visitor or general practitioner, referral to early intervention mental health services, or parenting support.

    Outcomes

    Assessments were made at baseline (prerandomization) and 5 months after randomization (posttreatment; primary end point) by trained researchers in participants’ homes or children’s centers. The primary outcome was severity of behavior problems, assessed using a modified early childhood version of the Preschool Parental Account of Children’s Symptoms (PPACS).21 The PPACS is a semistructured researcher-led interview administered to a parent or caregiver. Interviews are the criterion standard outcome measure as they provide a more complete picture of children’s symptoms than is possible from questionnaires.22,23 To determine scores, the primary caregiver provides detailed examples of the child’s typical behavior over the last week and indicates how representative the behavior is of the last 4 months. A trained interviewer then rates the severity and frequency of the symptoms based on their professional judgment and written thresholds. The measure comprises 2 subscales: conduct problems and attention-deficit/hyperactivity disorder or hyperkinesis. The PPACS has good psychometric properties and has been used in previous RCTs.21,24-27 Interviews were recorded, and 10% (30 of 300) were randomly selected for double scoring at each time point; high reliability was observed (intraclass correlations, 0.93-0.97). The PPACS scores at 2 years after randomization were included as a secondary outcome and will be reported later.

    Two other parent-reported measures of child behavior were used: the Child Behavior Checklist (CBCL)28 and the SDQ.18 The widely used and psychometrically robust CBCL provides total, internalizing, and externalizing scores. The externalizing scale comprises syndrome scores for attention and aggression problems. The SDQ is a brief and widely used measure that yields a total difficulties score and scores for emotional difficulties, peer problems, conduct problems, hyperactivity, and prosocial behavior. The conduct problems and hyperactivity scales can be combined to yield an externalizing subscale.

    Other secondary outcomes were parent-reported parental discipline (the Parenting Scale), mood (the Patient Health Questionnaire–9), anxiety (the Generalized Anxiety Disorder Questionnaire–7), and relationship adjustment (the Revised Dyadic Adjustment Scale). As this was a low-risk study, only serious adverse events were recorded.

    Fidelity was assessed on approximately 10% of sessions (77 of 777) by 2 VIPP-SD–trained assessors (interrater reliability; intraclass correlation, 0.69) using a 5-point scale of manual adherence. A score of 3 indicated the presence of most core intervention components.

    Changes to Protocol

    The posttreatment assessment was changed from 4 to 5 months after randomization early in the study, as the full intervention was not always completed within this time frame.

    Sample Size and Statistical Analysis

    Analysis was performed on an intention-to-treat basis. Results were interpreted based on point estimates and 95% CIs. The target sample size was 300 families, which would provide 80% power to detect a standardized effect size of 0.36 and 90% power to detect a standardized effect size of 0.42 at the 5% significance level, assuming 20% attrition (based on mean comparison at follow-up, with greater anticipated power because analyses adjust for baseline scores). A pooled effect size on child behavior was not available at study design. However, the sample size was considered reasonable because the effect size was 0.46 for previous RCTs of VIPP-SD on parental sensitivity and 0.69 from a National Institute for Health and Care Excellence systematic review of interventions targeting behavior problems,29 albeit in older children using researcher-rated outcomes.

    Statistical analysis was performed from September 5, 2019, to January 17, 2020. The primary analysis was based on multiple linear regression to assess the primary outcome: group difference in mean PPACS score at 5 months after randomization. The PPACS score at 5 months was the dependent variable; trial group, PPACS score at baseline, time since randomization, recruitment center, age of child at recruitment, and number of parents or caregivers participating (1 or 2) were included as independent variables. Similar models, with adjustment for the appropriate baseline score, assessed difference in CBCL and SDQ scores between the trial groups at 5 months. Missing data for individual PPACS items at baseline and completely missing PPACS scores at 5 months were imputed. Missing items in the other outcomes (parental discipline, mood, anxiety, and couple functioning) were scaled up.

    For imputation of the primary outcome, the level, pattern, and likely causes of missingness in the baseline variables and primary outcome were investigated. The imputation of individual missing items when the PPACS interview was mostly but not fully completed was based on completed items and subscales from baseline PPACS (for baseline scores) and PPACS at 5 months (for 5-month scores). Multiple imputation of the whole PPACS score when the entire scale was missing (it was never missing at baseline) was based on randomized group, child sex, child age at 5-month assessment, and baseline PPACS, CBCL, and SDQ scores.

    As sensitivity analyses, analysis of the primary outcome was repeated without adjustment for time since randomization and using complete cases after multiple imputation of missing items only, assuming that losses to follow-up do better or worse than expected per multiple imputation and assuming the highest and lowest possible scores for missing items. Secondary analysis involved complier average causal effects analysis using 2-stage, least-squares regression analysis to determine the effect of actually receiving the intervention, predefined as receipt of 4 core VIPP-SD visits.

    Planned subgroup analyses of the primary outcome involved the effects of child age at baseline (12-23 months vs 24-36 months) and the number of caregivers participating (1 vs 2). We also undertook post hoc subgroup analyses to assess the effect of severity of child behavior problems at study entry (by quartile of baseline SDQ score) and to compare White caregivers with caregivers of all other racial/ethnic groups combined.

    Standardized effect sizes were calculated as Cohen d by dividing the mean difference (from the linear regression models) by the SD at follow-up in the UC group. Statistical analyses used Stata, versions 13 and 15 (StataCorp LLC). A data monitoring and ethics committee oversaw the study. Serious adverse events were compared between groups using the Fisher exact test.

    Results

    A total of 2248 potential participants were screened between July 30, 2015, and July 26, 2017. Of these, 300 eligible participants consented to the trial and were randomly allocated to receive either VIPP-SD plus UC (n = 151) or UC alone (n = 149). The Figure shows participant flow. Table 1 shows that baseline characteristics of participants and their children (mean [SD] age, 23.0 [6.7] months) were generally well balanced between groups but that there were slightly more male children in the UC group than the VIPP-SD group (87 [58%] vs 76 [50%]) and there were small differences in reported race/ethnicity because the randomization was not stratified by these factors (see eTable 1 in Supplement 2 for baseline characteristics of second caregivers).

    Treatment adherence was high: 121 of 151 (80%) participants received all 6 sessions, and 129 of 151 (85%) received 4 or more sessions (the cutoff for treatment adherence). Treatment fidelity was also high: 72 of the 77 randomly assessed sessions (94%) met the minimum fidelity threshold. The mean (SD) score for fidelity across sessions was 3.66 (0.60).

    Child behavior outcome results are given in Table 2. There was a difference in mean PPACS score (primary outcome) between the trial groups (adjusted mean difference, 2.03 [95% CI, 0.06-4.01]; P = .04; d = 0.20 [95% CI, 0.01-0.40]), with fewer behavior problems in children in the VIPP-SD group (mean [SD] PPACS score, 28.8 [9.2]) compared with the UC group (mean [SD] PPACS score, 30.3 [9.9]). There was a difference in scores on the PPACS conduct problems subscale between the trial groups (mean difference, 1.61 [95% CI, 0.44-2.78]; P = .007; d = 0.30 [95% CI, 0.08-0.51]) but little difference in scores on the hyperactivity subscale (mean difference, 0.29 [95% CI, −1.06 to 1.65]; P = .67; d = 0.05 [95% CI, –0.17 to 0.27]). The mean group differences in primary caregiver–reported CBCL and SDQ scores were also consistent with the primary outcome findings (see subscale analysis in eTable 2 in Supplement 2). There were no appreciable group differences in the other secondary outcomes of parent or caregiver–reported disciplinary behavior, mood, anxiety, or couple functioning (Table 3).

    Sensitivity analyses (eFigure 1 in Supplement 2) suggest that the difference in PPACS scores between the trial groups is approximately 2 under most alternatives. Assuming that losses to follow-up were associated with better outcomes gave an estimated treatment effect of 2.42, and replacing missing items with the maximum possible score gave an estimated treatment effect of 2.56. Complier average causal effects analysis suggested that the treatment effect was stronger in those with acceptable levels of treatment adherence (≥4 core VIPP-SD sessions; mean difference between trial groups per PPACS, 2.59 [95% CI, 0.24-4.94; d = 0.26]; mean difference between trial groups per CBCL, 3.56 [95% CI, 0.04-7.09; d = 0.17]; mean difference between trial groups per SDQ, 1.03 [95% CI, −0.01 to 2.06; d = 0.20]) (eTable 3 in Supplement 2).

    Subgroup analyses (eFigure 2 in Supplement 2) all had substantially overlapping 95% CIs; hence, there is considerable uncertainty regarding conclusions. Treatment effects appear to be greater in younger children, in families with 1 participating caregiver, and in those with the worst baseline behavior scores. There were no clear differences between racial/ethnic groups: the adjusted difference in mean PPACS score between treatment groups is 2.17 (95% CI,−0.13 to 4.47) in White primary caregivers and is 2.45 (95% CI,−1.90 to 6.79) in caregivers of other racial/ethnic groups.

    In families who received VIPP-SD, 3 of 139 children (2%) had serious adverse events compared with 4 of 161 children from other families (3%; P = .60). All serious adverse events were unrelated inpatient hospital admissions (eg, accidents or respiratory infections). The mean (SD) follow-up was 161 (26) days from randomization in UC and 204 (62) days in the VIPP-SD group. Protocol deviations and violations pertained mainly to noncompletion of VIPP-SD visits and/or noncompletion or delays in posttreatment assessments (eTable 4 in Supplement 2).

    Discussion

    We found clear evidence that a brief, home-based intervention, VIPP-SD, was more effective than UC in reducing behavior problems in this group of 1-year-old and 2-year-old children. Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline uses video feedback from sessions involving a parent’s or caregiver’s interactions with their child, where the therapist shares feedback to promote sensitive responding and consistent discipline. Evidence of superiority was found for the primary outcome (the interview-based PPACS assessment), with results on the 2 measures of child problems (CBCL and SDQ questionnaires) being consistent with this finding. The secondary analysis of treatment compliance further supported the intervention’s efficacy such that families who received the core number of VIPP-SD sessions (≥4) demonstrated a larger improvement in behavior. The effect size for the VIPP-SD intervention (0.20) is somewhat difficult to interpret for an individual child or family; however, it represents a mean difference of 2 points on the PPACS measure. By way of example, for tantrums, this 2-point difference would equate to a change from severe (breaking things) to mild (shouting) or a change in frequency from daily to once or twice per week. For destructiveness, this 2-point difference would be a change from deliberately destroying items in the home or causing mild damage outside the home to no destructive behavior. These examples demonstrate that a 2-point difference represents a clear change in child behavior.

    The beneficial effect of VIPP-SD appeared to be most prominent in the PPACS assessment of conduct problems rather than attention problems. This finding is in keeping with the sensitive discipline focus of the intervention, which targets conduct problems. Evidence since this trial was designed also suggests that conduct problems in particular are associated with poorer long-term outcomes for children and are more amenable to treatment than early attention-deficit/hyperactivity disorder or hyperkinesis problems.30-32 The findings also suggest that the effect of treatment may be greater in those with higher levels of symptoms and that the intervention is at least as effective for 1-year-old children as for 2-year-old children.

    Previous smaller studies of VIPP-SD have shown similar findings, with a meta-analysis demonstrating a similar effect size for child behavior.16 However, to our knowledge, this is the first pragmatic trial of VIPP-SD conducted in a routine NHS health care setting, and the findings are robust in this setting. The intervention is also acceptable for a psychological treatment as indicated by the high levels of adherence. A substantial body of evidence for the efficacy of several interventions already exists for childhood behavior problems; however, there is much less evidence for very young children in routine practice and no evidence of this kind in the UK. This is the first effectiveness study, to our knowledge, to demonstrate a beneficial treatment effect in 1-year-old children and in routine practice. This finding is important, as there are many examples of promising interventions for child mental health problems that do not show a clear benefit when used in routine care despite initial evidence of efficacy in other more tightly controlled trial conditions.33-35 Consequently, these findings, including high levels of fidelity, indicate that the intervention can be reliably and successfully delivered in routine NHS practice by health visitors and community nursery nurses. The study findings also add to encouraging evidence for other interventions focused on improving caregiver sensitivity in community settings, such as Attachment and Biobehavioral CatchUp.36,37

    We did not observe treatment effects on parental mood, anxiety, relationship adjustment, or self-reported discipline. Evidence suggests that parenting programs may not be sufficiently powerful in and of themselves to shift global indicators of distress.38 Alternative measures of parental factors, such as parental self-efficacy, may be useful for future trials, as this may be one pathway by which interventions like VIPP-SD exert their effect.

    Strengths and Limitations

    This study has some strengths, including its multicenter pragmatic design, which recruited families in routine health care settings in urban, suburban, and rural settings in the UK. The VIPP-SD intervention was acceptable to participants, with a very high level of retention (95%). This level of retention may result in part because of the intervention’s home delivery, which is likely to be more acceptable for families. The study also benefited from an interview measure of child behavior, which allowed the researcher to gather detailed information about symptoms based on both their severity and frequency that was not weighted by the parent but by the researcher according to strict criteria.

    This study also has some limitations. It did not include a formal assessment of impairment, which is challenging to do in younger children. Secondary outcomes relied on parent-completed questionnaires, and no other reporters of child behavior were used in this assessment. The SDQ and CBCL have limited previous use in children as young as 1 year. Uptake of the invitation to participate in the study was in line with similar trials but could possibly be improved in clinical practice with more direct contact with families and use of motivational techniques. Like many RCTs, the study participants had somewhat higher levels of education than the national average, although in most other respects they were similar to families in recruitment areas. In addition, we found that not all therapists were able to deliver the intervention, largely owing to service changes, which meant that planned time to deliver the treatment became restricted. Further research is needed to examine the long-term implications of the intervention.

    Conclusions

    The findings of this RCT of VIPP-SD, a brief, home-based parenting intervention, demonstrated that the intervention was effective at reducing behavior problems, particularly conduct problems, in very young children. The study indicates that there is substantial potential for VIPP-SD to be delivered successfully by community health staff in routine practice. Despite a strong global policy focus on early intervention, a lack of effective interventions is one of the key problems holding back the field from improving children’s health, education, and social outcomes.39-41 Thus, the results of this study represent a new opportunity for effective early childhood intervention to prevent mental health problems.

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    Article Information

    Accepted for Publication: November 3, 2020.

    Published Online: March 15, 2021. doi:10.1001/jamapediatrics.2020.6834

    Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 O’Farrelly C et al. JAMA Pediatrics.

    Corresponding Author: Paul G. Ramchandani, DPhil, PEDAL Research Centre, Faculty of Education, University of Cambridge, 184 Hills Rd, Cambridge CB2 8PQ, United Kingdom (pr441@cam.ac.uk).

    Author Contributions: Ms Watt and Dr Ramchandani had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Watt, Bakermans-Kranenburg, Byford, Iles, Scott, Stein, van IJzendoorn, Warwick, Ramchandani.

    Acquisition, analysis, or interpretation of data: O’Farrelly, Watt, Babalis, Bakermans-Kranenburg, Barker, Byford, Ganguli, Grimas, Iles, Mattock, McGinley, Phillips, Ryan, Smith, Stevens, van IJzendoorn, Warwick, Ramchandani.

    Drafting of the manuscript: O’Farrelly, Watt, Byford, Ganguli, Iles, Phillips, Warwick, Ramchandani.

    Critical revision of the manuscript for important intellectual content: O’Farrelly, Watt, Babalis, Bakermans-Kranenburg, Barker, Byford, Grimas, Mattock, McGinley, Ryan, Scott, Smith, Stein, Stevens, van IJzendoorn, Warwick, Ramchandani.

    Statistical analysis: Watt, Bakermans-Kranenburg, Ganguli, van IJzendoorn, Warwick.

    Obtained funding: Watt, Bakermans-Kranenburg, Byford, Stein, van IJzendoorn, Warwick, Ramchandani.

    Administrative, technical, or material support: O’Farrelly, Babalis, Barker, Grimas, Mattock, McGinley, Phillips, Ryan, Scott, Smith, Stevens.

    Supervision: Bakermans-Kranenburg, Byford, Iles, Stein, Stevens, van IJzendoorn, Warwick, Ramchandani.

    Conflict of Interest Disclosures: Drs O’Farrelly, Babalis, Byford, Grimas, Iles, Scott, Stein, and Ramchandani and Mss Watt, Barker, Mattock, and Smith reported receiving grants from the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) during the conduct of the study. Drs Bakermans-Kranenburg and van IJzendoorn reported being developers of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) intervention program tested. Dr Iles reported being employed by Imperial College London during the conduct of the study; training clinicians and researchers to deliver VIPP-SD for 2 other research studies; and being employed to work on 1 of these studies (funded by the National Institute for Health Research Research for Patient Benefit) outside the submitted work. Dr Ramchandani reported directing the Play in Education, Development, and Learning (PEDAL) Research Centre at the University of Cambridge, which received a donation for funding from the LEGO Foundation outside the submitted work. No other disclosures were reported.

    Funding/Support: This research was funded by an NIHR HTA programme grant (13/04/33) and the NIHR Biomedical Research Centre based at Imperial College Healthcare National Health Service (NHS) Trust and Imperial College London. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS, or the Department of Health.

    Role of the Funder/Sponsor: The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

    Data Sharing Statement: See Supplement 3.

    Additional Contributions: We thank the families who participated in the trial, the therapists who delivered the trial intervention, the clinical supervisors, and all of the sites that facilitated intervention delivery and assisted with recruitment. Camilla Rosan, DClinPsy, Anna Freud Centre, Esther Wilkinson, DClinPsy, Imperial College London, and Mike Crawford, MD, Imperial College London, assisted with study set up; they undertook this work as part of their paid roles at the time of the work. We are very grateful to the North West London NIHR Collaboration for Leadership in Applied Health Research and Care and the North West London and North Thames Clinical Research Networks for their support. We thank in particular for their recruitment and site support: Lynis Lewis, North Central London Research Network (Noclor) Research Support, Angela Williams, Noclor Research Support, Sandra O’Sullivan, NIHR North London Clinical Research Network, Letitia Coco-Bassey, Noclor Research Support, Maggie Waters, Central and North West London NHS Foundation Trust, Jane McGrath, Camden Council, Philippa Kemsley, Whittington Health NHS Trust, Kathryn Simpson, Whittington Health NHS Trust, Lynda Rowlinson, Whittington NHS Trust, Penny Kenway, Islington Council, Andrew Molodynski, Oxford Health NHS Foundation Trust, Jennifer Potts, Oxford Health NHS Foundation Trust, Sarah Mather, Oxford Health NHS Foundation Trust, James Sinclair, North East London NHS Foundation Trust, Awulatu Sellick-Taylor, North East London NHS Foundation Trust, Clare Knight, Cambridgeshire and Peterborough NHS Foundation Trust, Mary Cousins, Hertfordshire Community NHS Trust, and Diane Hammond, Hertfordshire Community NHS Trust; they undertook this work as part of their paid roles at the time of the work. We thank Rajinder Ballman, MSc, Imperial College London, for delivering training and the intervention and providing clinical supervision; she undertook this work as part of her paid role at the time of the work. We thank all those involved in the delivery of the intervention, including Toni Adewale, North East London NHS Foundation Trust, Fola Akinmutande, North East London NHS Foundation Trust, Rupali Archaya, Imperial College London, Kirsten Barnicot, Imperial College London, Florence Bristow, Royal Holloway, University of London, Emma Brown, Cambridgeshire and Peterborough NHS Foundation Trust, Sadie Burton, Cambridgeshire and Peterborough NHS Foundation Trust, Mary Cousins, Hertfordshire Community NHS Trust, Jill Domoney, King’s College London, Annette Eneberi, Royal Holloway, University of London, Diane Hammond, Hertfordshire Community NHS Trust, Marina Fabrega Ribera, Imperial College London, Janis Griffiths, Whittington Health NHS Trust, Anna Hemphill, Oxford Health NHS Foundation Trust, Philippa Kemsley, Whittington Health NHS Trust, Leonie Lee-Carbon, Imperial College London, Lorraine Mireku, Central and North West London NHS Foundation Trust, Ainoa Mateu Mullor, Imperial College London, Vangilista Nduku, North East London NHS Foundation Trust, Rachael Neville, Central and North West London NHS Foundation Trust, Emily Pearson, Imperial College London, Clare Pollard, Cambridgeshire and Peterborough NHS Foundation Trust, Uma Purohit, Central and North West London NHS Foundation Trust, Jacqueline Sangan, Oxford Health NHS Foundation Trust, Joanna Scales, Oxford Health NHS Foundation Trust, Caroline Thomas, Cambridgeshire and Peterborough NHS Foundation Trust, Fatima Valencia Agudo, Imperial College London, Verity Wilkinson, Whittington Health NHS Trust, and Sylvia Woolley, Oxford Health NHS Foundation Trust. We thank Ainoa Mateu Mullor, PsyD, Clinical Psychology, and Emily Pearson, MSc, Imperial College London, for their work in developing and conducting the fidelity assessments; they undertook this work as part of their paid roles at the time of the work. We are grateful for administrative support from Nicole Hickey, BSc, Hannah Kinch, BSc, Ruby Lee, MSc, and Kate Whitaker, DClinPsych, Imperial College London; they undertook this work as part of their paid roles at the time of the work. We thank Barbara Barrett, PhD, King’s College London, and David Daley, PhD, University of Nottingham, for delivering training for key trial measures; they were compensated for their contribution. We thank Femmie Juffer, PhD, Leiden University, for making the intervention available; Dr Juffer made the intervention freely available for use in the trial. We acknowledge the guidance and support of the external Trial Steering Committee (TSC) and Data Monitoring Ethics Committee (DMEC), especially the TSC chair, Paul Stallard, and the DMEC chair, Helen Bedford. Participating sites: Central and North West London NHS Foundation Trust, Whittington Health NHS Trust, Oxford Health NHS Foundation Trust, North East London NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust, and Hertfordshire Community NHS Trust. We are grateful to the principal investigators and local collaborators at the participating sites: Maggie Waters, Morris Zwi, Nicola Taylor, Alex Davis, Joy Coutts, Sarah Morton, and Sarah Barrett. TSC members: Jane Appleton, Erin Bibby, Richard Emsley, Sam Griffith, Bonamy Oliver, Paul Stallard, and Essi Viding. Former members: Pasco Fearon and Jonathan Freedman. DMEC members: Helen Bedford, Kapil Sayal, and Pat Yudkin. Project management group: Daphne Babalis, Marian Bakermans-Kranenburg, Sarah Byford, Poushali Ganguli, Marinus van IJzendoorn, Julia McGinley, Paul Ramchandani, Stephen Scott, Alan Stein, Jane Warwick, and Hilary Watt; Trial managers: Christine O’Farrelly and Jessica Smith. Patient and public involvement includes Erin Bibby, Sam Griffith, Kajal Hans, Amisha Seda, and Sunny Sudhan.

    Additional Information: All of the individual deidentified participant data collected during the trial (including data dictionaries), will be available 12 months after publication and for 5 years after date of publication. Data will be made available to researchers who provide a methodologically sound proposal and have the required institutional approvals in place to achieve aims in the approved proposal. Proposals should be directed to the corresponding author to gain access, and requestors will be asked to sign a data access agreement. The study protocol and informed consent form will also be available.

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