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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, 1,3-5 and physical development 2 and to reduce obesity risk. 6 At preschool age (3-5 years), 10 to 13 hours of sleep per day inclusive of naps is recommended. 7 Yet prior to school entry, up to one-third of US children do not sleep that much. 5,8,9 In addition, 25% to 30% of preschoolers experience difficulties falling and staying asleep, that is, behavioral sleep problems. 10,11 Yet 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. 12,13 Parent knowledge and attitudes about child sleep are significantly associated with the quality and quantity of sleep for children 1 to 5 years of age. 14,15 There 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. 21 Despite sleep health disparities, 22,23 population samples have lacked racial, ethnic, and socioeconomic diversity. 24 Half of the nation's preschoolers attend early childhood programs, 25 in which promoting sleep health is endorsed by parents and staff. 18,26,27 The 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. 15 Despite 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) child sleep duration, (2) child sleep difficulties, and (3) parent knowledge, attitudes, self-efficacy, and beliefs (KASB) regarding children's sleep.

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 prevention). [30][31][32][33]  Start staff obtained informed consent from participants, and the recruiting staff signed and dated consents on participants' behalf. Participants were not compensated but received a study-branded child-sized blanket. Agencies received funds to host study-related events (eg, refreshments for the parent workshop).

Design
We conducted a pragmatic, stepped-wedge cluster RCT. (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. 34

Preimplementation Phase
During 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.

Materials
The training and curriculum for teachers, children, and parents in the Early Childhood Sleep Education Program (ECSEP) served as core content. 15 The ECSEP classroom lessons align with preschool curricula; child and parent education fulfills Head Start performance standards. 35,36 Parent-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

Interventions
The study was implemented across the 2018 to 2019 school year. Head Start staff in each wedge received half-day trainings 1 month prior to implementing the ECSEP 1-hour parent workshop, 2-week classroom curriculum, and guided sleep health flip chart discussion (Table 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 (Individual Family Service Plan and Individualized Education Plan) data were abstracted from agency records by Head Start staff. Race and ethnicity data were collected because despite sleep health disparities, such data are limited. Head Start data classifies race as Alaskan Native, American Indian, Asian American, Black, Pacific Islander, White, and other. Ethnicity was classified as Hispanic or not.
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. 37,38 This low-literacy (Յ6th grade) questionnaire has been used in previous research. [39][40][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

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.

Sleep Outcomes by Time Point and Wedge
Across time point and wedge, children averaged at least 10 hours of weeknight sleep ( Table 2) 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.

Parental KASB Scores
At follow-up 4, the intervention was associated with a 1.13 unit increase from baseline in knowledge (95% CI, 0.13-2.12 units) (
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, 0.0-51.6 minutes) 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.

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."

Evaluation
Head Start classroom educators rated the ECSEP program and related training on a scale of 1 to 5 (with 5 being best). Across the 7 agencies, results were mean (SD) ratings of 4.82 (0.15) for learning objectives, 4.86 (0.00) for instructors, and 4.80 (0.09) for teaching methods and program content.

Discussion
This sizeable prospective stepped-wedge cluster RCT implemented a sleep health literacy program for children and parents in Head Start. Assessment of child sleep duration, child sleep difficulties, and parent KASB score outcomes at 9 and 12 months of follow-up failed to show clinically meaningful effects at the individual level. The primary outcome, nighttime sleep duration, increased to clinically insignificant means of 5.6 minutes at 9 months (primary outcome) and 6.8 minutes 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  43 Those 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. 49 Our 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. 54 Site 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. 55 The 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