Effects of a Sleep Health Education Program for Children and Parents on Child Sleep Duration and Difficulties

Key Points Question Does a sleep health education program for children and parents in Head Start improve childhood sleep and related outcomes? Findings This stepped-wedge cluster randomized clinical trial of 519 parent-child (aged 3 years at enrollment) dyads assessing the effects of a 2-week classroom curriculum for children, 1-hour parent workshop, and 1-on-1 parent discussions at home or school yielded largely negative 9- and 12-month outcomes for children’s sleep duration and difficulties and caregiver sleep, attitudes, self-efficacy and beliefs. Meaning These findings, although negative, provide direction for future research on the sustained impact, focus, and potential population-level effects of sleep education programs.


Introduction
Young children need sufficient, healthy sleep for optimal cognitive, 1-3 social-emotional, 1,[3][4][5] and physical development 2 and to reduce obesity risk. 6At preschool age (3-5 years), 10 to 13 hours of sleep per day inclusive of naps is recommended. 7Yet prior to school entry, up to one-third of US children do not sleep that much. 5,8,9In addition, 25% to 30% of preschoolers experience difficulties falling and staying asleep, that is, behavioral sleep problems. 10,11Yet optimal sleep hygiene practices at this age-including a consistent bedtime and bedtime routine, falling asleep on one's own, and limiting screen time before bed-are associated with fewer behavioral sleep problems and longer sleep duration. 12,13Parent knowledge and attitudes about child sleep are significantly associated with the quality and quantity of sleep for children 1 to 5 years of age. 14,15ere is growing attention to sleep health in general 16 and pediatric [17][18][19] populations.Research in preschool children (approximately 2.5-5 years of age) has prioritized home-based interventions, 20 or interventions targeting obesity rather than sleep as a primary outcome. 21Despite sleep health disparities, 22,23 population samples have lacked racial, ethnic, and socioeconomic diversity. 24Half of the nation's preschoolers attend early childhood programs, 25 in which promoting sleep health is endorsed by parents and staff. 18,26,27The federal Head Start early childhood program serves approximately 700 000 diverse, lower-income preschoolers and their families.Research in Head Start finds that healthy sleep improves cognitive and social-emotional function, 3 and a randomized clinical trial (RCT) of parent and classroom education resulted in 30 minutes' longer sleep duration at the 1-month follow-up. 15spite evidence that sufficient quality sleep promotes development and brain function, Head Start does not routinely promote sleep health literacy.One reason may be lack of adequate evidence that sleep routines can be changed, sleep problems reduced, and parent knowledge about sleep improved.Thus, we conducted a primary prevention trial of sleep health interventions in Head Start.This RCT of multilevel interventions grounded in the social and ecological model 28,29 examined the following 3 outcomes at the 9-and 12-month follow-up: (1)

Design
We conducted a pragmatic, stepped-wedge cluster RCT.

Materials
The training and curriculum for teachers, children, and parents in the Early Childhood Sleep Education Program (ECSEP) served as core content. 15The ECSEP classroom lessons align with preschool curricula; child and parent education fulfills Head Start performance standards. 35,36rent-and child-facing education materials were available in English and Spanish.Details of study materials and how they were used to deliver interventions are shown in Table 1.

Training
Researchers trained agency staff to enroll families and administer study instruments.Approximately

Randomization
The  1).Classroom lessons and materials (eg, teddy bear, book) were provided to every classroom in buildings where there were study participants.Parents of all children in classrooms exposed to the intervention were invited to a parent workshop, which may or may not have been in the same building as the classroom.
Thus, more parents and children were exposed to ECSEP and related interventions than participated in the study.

Demographic Characteristics
Race and ethnicity, preferred language (English or Spanish), and child enrollment in special education To explore associations between sleep and childhood obesity, we converted height and weight data from physician records that parents submit at enrollment to Head Start to body mass index z scores using the US Centers for Disease Control and Prevention growth references for the year 2000.

Child Sleep Duration
Child sleep duration was measured from sleep log data for school nights (Sunday through Thursday).
At recruitment, agency staff showed parents how to record their child's bedtimes and wake times,  defined as "lights out" and "when the child woke up to start the day," respectively.Parents completed 7-day paper (not computer) sleep logs at 5 points: 1 week before and 1 week after implementation in wedges 1 and 2, and at the final 1-year follow-up (follow-up 4).Hypothesized differences in sleep duration for intervention vs control periods were (a) longer duration for intervention periods (primary outcome: difference at follow-up 3, which occurred at approximately 9 months), (b) more than a 30-minute difference at follow-up 3, and (c) a 15-minute difference in duration at follow-up 4.
Logs with data for at least 4 of 5 school-night sleep durations were considered evaluable and were included in the analysis.

Child Sleep Difficulties
Child sleep difficulties were assessed with the Tayside Children's Sleep Questionnaire (Tayside).This valid and reliable 10-item tool assesses difficulties initiating and maintaining sleep in children 1 to 5 years of age. 37,380][41] For this RCT, we reduced the recall period from 3 months to 2 months, and we edited the language for clarity (eg, revised double negatives).The first 9 items were each scored from 1 to 4; a total score of 8 or higher of 36 possible indicated mild to moderate difficulties.The 10th item asked caregivers (yes vs no) whether their child had sleep difficulties.Hypothesized differences between intervention vs control periods were (a) lower mean total scores, (b) lower odds of scores being 8 or higher, and (c) fewer parents reporting a sleep problem (yes vs no) in the 10th item on the Tayside questionnaire.Surveys with at least 7 of 9 items scored were included in analyses (secondary outcome).

Parent KASB Questionnaire
The KASB questionnaire reflects content from the ECSEP parent workshop regarding child sleep across the named domains.Parents rated agreement with 27 items on a 5-point scale for knowledge (12 items), attitudes (5 items), self-efficacy (8 items), and beliefs (2 items).One multiple-choice item asked how much sleep a preschooler required.In our pilot RCT of the ECSEP, 15 11 of the 12 knowledge items split into 3 factors: a 3-item scale about television, a 5-item scale about bedtime routines, and a 3-item scale about activities before bedtime, with Cronbach α values of 0.85, 0.79, and 0.77, respectively.The 5 attitude items had a Cronbach α of 0.91, the 7 self-efficacy items had a Cronbach α of 0.90, and the 2 belief items had a Cronbach α of 0.94.
Hypothesized differences in parents' KASB for intervention vs control periods were (a) higher KASB total scores and (b) higher scores for each domain; KASB scales with at least 80% nonmissing responses were included in analyses (secondary outcome).

Statistical Analysis Power
Mean school-night sleep duration at follow-up 3 (at approximately 9 months) was the primary outcome.Clinically significant effects are evident from an additional 30 to 35 minutes of nighttime sleep. 42,43

Sleep Outcomes by Time Point and Wedge
Across time point and wedge, children averaged at least 10 hours of weeknight sleep ( of 147 [6.1%] at follow-up 4).The KASB total and domain scores appeared to remain stable over time.
All remaining results were adjusted for phase (ie, intervention vs control), age, sex, race, ethnicity, and agency.
We explored adjustment for additional site-and participant-level effects for sleep duration across follow-up 3 and follow-up 4 (eTable 3 in Supplement 2).We included an indicator for each of the 23 sites (in addition to random effects for 7 agencies), as well as person-level covariates (eg, language, ethnicity, and race), and site setting as urban vs rural per US Census data.At the participant level, we evaluated effects of participant language (English vs Spanish), Tayside questionnaire total and sleep difficulty scores at baseline, and total Tayside questionnaire score at the observation point.
None of these adjustments led to a different estimate of the intervention effect.The adjusted mean sleep duration at baseline was 25 minutes (95% CI, 0.0-51.6minutes) shorter in the rural site than in urban sites.However, because this finding was based on a single site, this result may not generalize.

Missing Data
Hispanic ethnicity was missing for 60 participants, and sex was missing for 10 participants.Sleep duration was missing for 75 children at baseline, 70 at follow-up 1, 102 at follow-up 2, and 165 at follow-up 3. We performed multiple imputation by chained equations, with 75 replicates, and applied the Rubin rules, obtaining an intervention effect estimate of 7.8 minutes (95% CI, 0.2-15.4minutes).
In addition, because the data may well be missing not at random, we performed a best case sensitivity analysis in which preintervention missing sleep durations were set to the child's shortest observed, and postintervention missing sleep durations were set to the longest observed.Missing values of Hispanic ethnicity were set to non-Hispanic, and missing values of sex to female because these categories were more favorable in the observed data.Under these optimistic imputations, the estimated intervention effect was 10.0 minutes (95% CI, 4.7-15.4minutes).

Fidelity
In-person observations of parent workshops from 3 agencies yielded positive assessment of staff preparation and thoroughness.On the basis of classroom observations (5 in-person and 1 video) from 6 agencies, teaching teams ably integrated material into the curriculum.Implementation of steps in specific days' lessons were quantified at 58%, 53%, 33%, 11%, and 50%.In contrast, the evaluator's report noted that learning objectives for lessons were more consistently met and that "teaching teams in most sites seemed to easily integrate these materials into their ongoing curriculum."(standardized effect size, −0.9; 95% CI, −2.2 to 0.4).Similarly, school-night sleep duration was longer in their intervention group at 6 months (mean difference, 10.9 minutes; 95% CI, 3.4-18.5minutes)

Evaluation
but not at 12 months (mean difference, −0.8 minutes; 95% CI, −0.83 to 6.8 minutes). 46Thus, research suggests that sleep education programs will require reinforcement over time along with serial monitoring of parent (eg, KASB) and child (eg, Tayside questionnaire, sleep logs) outcomes.
Small increments in sleep duration during early childhood may have population level effects because sleep affects the developing brain. 47,48Our hypotheses of increased sleep duration of 30 minutes after 9 months (follow-up 3) and of 15 minutes after 1 year (follow-up 4) came from studies finding that 30 to 35 minutes' extra sleep conferred attention and emotional benefits 42 and neurobehavioral gains equivalent to 2 developmental years. 43Those were small studies (<80 participants) of typically developing school-aged children (7-12 years of age) whose sleep was experimentally manipulated across 3 to 5 nights.In real-world conditions, 5 to 7 minutes' longer nightly sleep across months or years in early childhood may prove meaningful, particularly because nighttime sleep normatively decreases 5 minutes per year between ages 2 and 6 years. 49Our precision estimates ranged from 2 minutes' less nighttime sleep to nearly 14 minutes' more nighttime sleep.Effects might be amplified in Head Start given the racial and economic disparities in sleep health 23,50 and the high rates of sleep problems in children with disabilities, 51,52 who comprise 10% of children in Head Start. 53

Strengths and Limitations
This study has strengths, including a large sample size, multiple sites, repeated measurements, a racially and ethnically diverse population, and 1 year of follow-up.Intervention materials were either previously tested (ie, the ECSEP) or collaboratively developed, thus increasing acceptability.Most important, this pragmatic trial evaluated the effectiveness of interventions under real-world conditions. 54Site staff delivered interventions that met curriculum goals and during the individual and monthly group parent meetings required by Head Start.In addition, fidelity data were consistent with the pragmatic trial.
The limitations of this study included those associated with stepped-wedge trials, such as respondent burden and practice effects of repeated measures. 55The study also lacked objective estimates of sleep duration (eg, actigraphy) although the baseline sleep duration (approximately 10.4 hours) matched that reported by nearly 3000 parents of children aged 3 and 4 years in Head Start. 3

1
month prior to the implementation of interventions at each site, developers of the ECSEP (Sweet Dreamzzz, now part of Pajama Program) provided half-day training to staff delivering the parent workshop, classroom lessons, and sleep health flip chart.Eligibility From March 19 through September 28, 2018, Head Start staff recruited (a) English-or Spanishspeaking parents (b) of children 3 years of age on or about September 2018 (c) who planned to remain at the site through the 2018 to 2019 school year.Enrolling only children who were 3 years of age (vs 3 and 4 years) was selected to account for developmental changes in sleep and to increase retention at the 12-month follow-up.
Abbreviations: ECSEP, Early Childhood Sleep Education Program; FAQs, frequently asked questions.aSupplemental lessons for future use; not implemented during this trial.
Checklists were developed to assess the fidelity of Head Start staff in delivering the ECSEP parent workshop and classroom curriculum.Research team members applied the checklist to in-person and video observations of its parent and classroom education for (a) training and educational materials (availability and appropriate use), (b) procedure (eg, distribution of teddy bears to children and takehome guides to parents), (c) workshop and lesson plans (steps followed), and (d) qualitative comments.

Setting
Head Start agencies from urban, suburban, and rural areas across New York State were selected based on having implemented low health literacy education programs (eg, oral health, obesity

JAMA Network Open | Pediatrics Effects
of Sleep Health Education for Children and Parents on Child Sleep Duration 30-33 This implementation approach from the Health Care Institute at the Anderson School of Management (University of California, Los Angeles) builds Head Start agency capacity to both collect data and implement interventions.The present report follows the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline for RCTs.The Office of Human Research Affairs at Albert Einstein College of Medicine, Bronx, New York, approved this study.Head Start staff obtained informed consent from participants, and the recruiting staff signed and dated JAMA Network Open.2022;5(7):e2223692. doi:10.1001/jamanetworkopen.2022.23692(Reprinted) July 26, 2022 2/14 Downloaded From: https://jamanetwork.com/ on 09/26/2023 prevention).
(Pragmatic trials evaluate the effectiveness of interventions under actual practice conditions.)The trial protocol and statistical plan are available in Supplement 1. Head Start agencies were randomly assigned to wedge 1 (4 agencies) or wedge 2 (3 agencies).The 23 sites within those agencies collected data at baseline, before and after intervention implementation in wedges 1 and 2 (fall of 2018 and early in 2019, respectively), and at the 1-year follow-up (September 2019) (eFigure in Supplement 2).This design is often used for routine care interventions that have a favorable ratio of benefit to harm. 34eimplementation PhaseDuring the 2.5 years of the preimplementation phase, the study team and partners developed and pilot tested intervention materials and built Head Start capacity to enroll participants, deliver interventions, and collect study data.A kickoff retreat in March 2018, just prior to recruitment, was held to review the logistics and materials.

Table 1 .
Intervention Descriptions: Content, Delivery, and Materials Lessons: 8 sessions in 2 weeks, 40 min/d Small-and large-group activity Effects of Sleep Health Education for Children and Parents on Child Sleep DurationWe conducted a modified intention-to-treat analysis that excluded participants with only baseline data.Summary statistics of continuous variables were calculated as means and SDs; frequency distributions (number and percentage) were calculated for discrete variables.To analyze treatment effects, we fitted generalized linear mixed models with the study outcome variables as dependent variables, an indicator for postintervention status, indicators for the study phase (follow-ups 1-4, baseline as the reference category), and covariates to adjust for age, child sex, Hispanic ethnicity, and race.Random intercepts at the agency and participant levels were included.For continuous outcomes (sleep duration, questionnaire scale scores) the identity link and gaussian distribution were used.The coefficient of the postintervention indicator was the estimate of the mean treatment effect and is presented along with its 95% CI.For dichotomous outcomes (positive Tayside questionnaire score, parent-reported sleep problem), the logit link with a Bernoulli distribution was used.In this model, the treatment was the odds ratio (exponentiated coefficient) of the postintervention indicator, presented with its 95% CI.All analyses were conducted with Stata, versions 16.1 and 17 (StataCorp LLC).A 2-sided value of P < .05 or a 95% CI excluding 0 was considered statistically significant.Effects of Sleep Health Education for Children and Parents on Child Sleep Duration With 7agencies, a sample of 173 provided 90% power to detect a difference as small as 15 minutes between intervention vs control phases (2-tailed P < .05).For parent KASB questionnaires, a secondary outcome, a sample of 450 provided more than 97% power to detect a moderate effect size (Cohen d, 0.3) for each of its named scales.JAMA Network Open | PediatricsJAMA Network Open.2022;5(7):e2223692.doi:10.1001/jamanetworkopen.2022.23692(Reprinted)July26, 2022 5/14 Downloaded From: https://jamanetwork.com/ on 09/26/2023 Analysis Results In total, 551 parent-child dyads provided informed consent.Excluding 4 participants who were later deemed ineligible and 28 participants who provided only baseline data yielded an analytic sample of 519 dyads.Based on evaluable sleep logs, retention was 395 (76.1%) at follow-up 2, 329 (63.3%) at follow-up 3, and 288 (55.5%) at follow-up 4 (Figure).Altogether, 1142 children across 65 classrooms were exposed to the ECSEP interventions.Description of Sample at Baseline and End Point Follow-upsAt baseline, of 519 children in the sample, 264 were girls (50.9%), 239 were boys (46.1%), 196 (37.8%) lived in Spanish-speaking households, and 5 (0.9%) identified as Alaskan Native or American Indian, 17 (3.2%)as Asian American or Pacific Islander, 57 (10.8%) as Black, 199 (37.8%) as White, and 63 (12.0%) as other (eTable 1 in Supplement 2).The mean (SD) age of the children at enrollment was JAMA Network Open.2022;5(7):e2223692.doi:10.1001/jamanetworkopen.2022.23692(Reprinted) July 26, 2022 6/14 Downloaded From: https://jamanetwork.com/ on 09/26/2023 2.7 (0.1) years.Mean body mass index remained within a healthy range throughout the trial 44 and thus was not included in further analyses.

Table 3 .
Sleep Duration Outcomes: Regression Model Effects, Primary Outcomes

Table 4 .
Parent KASB and Child Sleep Difficulties at Follow-up 4: Regression Model Effects, Secondary Outcomes a Odds of scoring 8 or higher (out of 36), indicating possible to mild sleep difficulty.b Odds of parent reporting "yes" regarding child sleep problem.
15,18,s of Sleep Health Education for Children and Parents on Child Sleep Duration children whose baseline school-night sleep duration was less than 10 hours.Findings of this trial have implications for the content focus and sustained impact of sleep education programs and potential for population-vs individual-level impacts.Child sleep difficulties were prevalent: two-thirds of children met criteria for sleep difficulties at baseline and nearly half met the criteria 1 year later.However, few parents thought their child had a sleep problem even after exposure to interventions (weighted average of wedge 1 and wedge 2, 12.5% at baseline and 8.7% at 12-month follow-up).This gap between parent perceptions and measures of child sleep problems is consistent with prior research.13,18,45Areview of parent knowledge concluded that "more effort ...be made to ensure that parents understand children's sleep requirements, what represents good sleep hygiene and also signs of sleep problems."13Futureparenteducationmayrequire both reinforcement over time and sharper focus regarding what constitutes a sleep problem.There is limited translational research on early childhood sleep health or sleep problems in nonclinical sample populations.A previous trial in Head Start of the ECSEP (alone) conducted by our research team found 30-minute increased sleep duration, but no KASB changes, after 1 month.15Theshorter follow-up period in that trial, and that developers of the ECSEP delivered the intervention, may underlie the difference in results.In another trial, school nurses delivered sleep hygiene education, including behavioral sleep strategies, to parents of children 5 years of age with behavioral sleep problems.The intervention group experienced fewer sleep difficulties compared with controls at 6 months (standardized effect size, −0.2; 95% CI, −0.4 to −0.04) but not at 12 months The intervention led to a slight improvement in parental knowledge, but not in attitudes, selfefficacy, or beliefs.Although child sleep difficulties decreased over time, this decrease was independent of the intervention, perhaps attributable to age or attrition effects.The findings remained essentially unchanged when analyses were adjusted for several covariates (eTable 3 in Supplement 2).Moreover, an effect modification analysis showed a similarly small effect among JAMA Network Open | Pediatrics JAMA Network Open.2022;5(7):e2223692.doi:10.1001/jamanetworkopen.2022.23692(Reprinted) July 26, 2022 9/14 Downloaded From: https://jamanetwork.com/ on 09/26/2023