A Pilot Randomized Control Trial Demonstrating the Efficacy of the SIESTA Sleep Hygiene Intervention

Abstract

Shorter sleep duration can negatively impact children’s daytime functioning and health. Latino children living near urban areas in the Mainland U.S. and Island Puerto Rico (PR) can be exposed to urban poverty and sociocultural stressors that challenge optimal sleep outcomes. Interventions to improve urban Latino children’s sleep health should consider families’ cultural background and environmental context to enhance acceptability and feasibility. This work describes our stepwise, multi-method approach to adapting a culturally and contextually tailored “School Intervention to Enhance Latino Students’ Time Asleep (SIESTA)” for 6–8^th grade Latino children residing in Greater Providence and San Juan, and findings from a pilot randomized control trial demonstrating SIESTA’s efficacy. Results indicated high acceptability and greater improvement of sleep duration and behaviors in SIESTA versus control participants. SIESTA shows potential to improve sleep outcomes in urban Latino middle schoolers. Results will inform a large-scale RCT to evaluate SIESTA’s effectiveness and barriers to implementation.

Refinement and Preliminary Efficacy of a Culturally and Contextually Tailored Sleep Hygiene Intervention for Improving Sleep Duration in Urban Latino Children

Good sleep health (i.e., uninterrupted sleep of sufficient duration) is essential for children’s daytime functioning and physical health.^1,2 Poorer quality sleep characterized by increased awakenings and shorter duration is related to daytime sleepiness, inattention, and academic problems.^3–5 Conversely, experimental studies indicate that increasing sleep duration enhances attention,⁶ and emotion regulation,⁷ decreases impulsivity,⁴ and improves health outcomes (e.g., weight⁸).

Latinos comprise 18.7% of the US population, with growing communities in urban centers.⁹ Latinos in the Mainland US and Island Puerto Rico (PR) who live near urban settings are more likely exposed to stressors of urban poverty (e.g., family stress, suboptimal sleep environments, crowding, noise) that challenge optimal sleep behaviors^10,11 and shorten duration.^11,12 Urban poverty can exacerbate sleep outcomes for those from marginalized backgrounds,¹⁰ particularly Latino children.¹¹ Using population-based sampling in one of the only published studies of sleep in PR youth, we found that over half of the sample did not attain the recommended amount of sleep for their age group.¹² In other studies, mainland urban Latino children were more likely to experience poorer sleep than their Non-Latino White (NLW) peers if their caregivers reported frequent exposure to noises in the home and neighborhood and uncomfortable bedroom temperatures.^13–15

Additionally, Latino families may face specific cultural stressors (e.g., acculturative stress, discrimination, language barriers^10,16) that challenge consistent family sleep practices. Thus, factors related to families’ cultural background (e.g., acculturation, sleep beliefs) and the environment (e.g., neighborhood and household stressors) require consideration when evaluating how to improve sleep outcomes among urban Latino children.

Sleep hygiene, or consistent, adaptive sleep behaviors (i.e., regular sleep/wake schedules, eliminating disruptions in the bedroom), promotes optimal sleep health.^17,18 Published reports show that targeting sleep hygiene can improve sleep quality in children.^19–21 These U.S.-based interventions include sleep hygiene education only, or education and behavioral strategies (e.g., self-monitoring^19,21). While some included ethnically diverse participants,^18,21–23 none were culturally tailored. To our knowledge, our team has developed the only efficacious intervention addressing sleep behaviors in ethnically diverse urban middle school students,²¹ though not originally tailored and tested with specific ethnic groups.

Herein we describe our multimethod, systematic development of a culturally and contextually tailored sleep hygiene intervention for urban Latino middle school children, which also includes evaluating its acceptability and feasibility in a small open trial. We also report results from a pilot randomized control trial (RCT), allowing for evaluation of the refined intervention’s preliminary efficacy, to improve sleep hygiene and sleep outcomes in this targeted group.

Methods: Summary of Intervention Refinement Approach

Our intervention, “School Intervention to Enhance Latino Students’ Time Asleep” (SIESTA), originated from the “Sleep Smart Program” (SS), a pilot intervention with demonstrated efficacy for enhancing sleep hygiene and quality in urban, ethnically diverse early adolescents.²¹ Sleep Smart utilized behavioral strategies for improving sleep outcomes in children.^24–26 The program was evaluated only in one urban school setting²¹ and lacked specific focus on urban and cultural risks and sleep needs salient for urban Latino middle schoolers. During the middle school years, youth become increasingly independent with their sleep routines. Late adolescence is typically a time of suboptimal sleep hygiene, duration and quality, ^27,28 making middle school years an important time for sleep health promotion. We designed SIESTA by refining Sleep Smart to be delivered at public middle schools in Providence, RI and San Juan, PR by community-based, trained Bachelors-level facilitators. Including Puerto Rico as an additional study site enabled us to 1) characterize the sleep needs of island Puerto Rican children and their families, and 2) evaluate intervention receptivity and acceptability in PR.

Our refinement approach is guided by our prior work on sleep and chronic disease management within school, family, and cultural contexts,^29,30 and by our pediatric sleep and health disparities model.¹ Refinement goals included enhancing the intervention’s 1) relevance for urban, Latino middle schoolers and families, 2) effectiveness in both RI and PR middle schools, and 3) caregiver involvement, given their important role in children’s sleep health.³¹ In RI, we included all Latino ethnic subgroups to enhance SIESTA’s broader generalizability. We proposed that enhancing the cultural and contextual relevance of SIESTA would promote intervention efficacy, and that school delivery would enhance feasibility, standardization, ease of implementation, and potential for long-term sustainability.

Procedures for Intervention Refinement

We utilized a stepwise, multi-method approach to refine the manualized, group-based SIESTA intervention for Latino middle schoolers (grades 6–8) in Providence and San Juan. Our approach was guided by Barrera and colleagues’ five stages of cultural adaptations of behavioral health interventions (Figure 1).³² Stage 1 involved identifying elements of the original intervention to retain, setting refinement goals described below, and information-gathering involving a review of a) previous literature, b) results from our in-depth interviews and focus groups with Latino children and caregivers at both sites, and c) feedback from schools to anticipate challenges at both sites. Stage 2 included expert review and integration from the investigative team to develop the first draft of the intervention. Stage 3 involved a preliminary adaptation test and an open trial assessing acceptability and feasibility. Stage 4 involved integration of feedback from an open trial at both sites informing the 2^nd draft of the tailored intervention. Stage 5 involved testing SIESTA in a pilot randomized control trial.

Figure 1.

Stages of Cultural and Contextual Refinement

Stage 1. Identifying which elements to retain from our original intervention: Sleep Smart

Based on social learning theory, Sleep Smart²¹ consisted of 8, 40-minute sessions in an urban middle school. Twice-weekly sessions focused on improving sleep hygiene strategies effective with middle schoolers.^19,21 Caregivers received a weekly newsletter summarizing what their children learned. Core elements retained involved focus on: (a) essential components of sleep health education,³³ including psychoeducation about sleep hygiene (i.e., consistent sleep/wake schedule, healthy sleep environment, avoiding electronics before bed), the importance of healthy sleep practices; (b) the use of educational activities to increase engagement; (c) self-monitoring activities (e.g., a sleep diary); (d) goal-setting activities³⁴; and (e) caregiver involvement.³⁵

Intervention Objectives.

We then developed objectives for each intervention session. Per Table 1, we included several original Sleep Smart objectives, and integrated challenges and resources related to urban middle schoolers’ sleep hygiene practices informed by prior work. ^15,36,37 Objectives were applied to an initial framework of our refined intervention. We included 4 school-based group sessions shown to balance efficiency with integration of key behavioral health principles and students’ engagement.³⁸ We added two caregiver-child sessions to enhance caregivers’ involvement, reinforce key sleep behavioral strategies in child group sessions, develop goals, and allow for a home-based sleep environmental assessment (see Table 1 and Figure 2).

Table 1.

SIESTA Intervention Sessions

Sessions	SIESTA Objectives	Session Activities Consistent with Refinement Goals	Examples of Specific Adaptations to Integrate/Highlight from Information Gathering
Group Session 1	• Learn basic information (as well as misconceptions) about sleep and why it is important to maintain healthy sleep. • Learn about the consequences of inadequate sleep. • Discuss what sleep hygiene means and the importance of it. • Learn how complete an electronic sleep checklist. • Prepare to share material learned with family during home visit session.	• Icebreaker and group rules • Picture activity: Importance of sleep health • Myth or Fact game: Appropriate sleep timing and duration, napping, caffeine use, and electronics • Discuss sleep behaviors important to your family • Demonstrate response to electronic daily sleep assessment • To Do List (homework)	• Integrated parent feedback on keeping electronic daily sleep assessment as brief as possible, how often to receive reminder texts and how feedback should be provided • Integrated child feedback on making activities as engaging as possible
Home Visit 1	• Review objectives of the program. • Complete sleep environment assessment. • Review importance of sleep with caregiver and child. • Provide child an opportunity to demonstrate what he/she learned in first group session. • Develop actionable goals with caregiver and child to improve sleep duration and quality (with guidance from facilitator based on prior data from sleep needs assessment).	• Icebreaker and review of structure of program • Assess child’s sleep environment (Interview) • Facilitator assists child in teaching caregiver about sleep • Child’s current sleep patterns (from electronic daily sleep assessment) are reviewed visually with family • Facilitator uses data to assist family in setting goals for sleep schedule, sleep hygiene, and sleep environment • Anticipate and problem solve barriers • Discuss ways to motivate child to adhere to plan	• Addressed/acknowledged children sharing sleep space with other family members in sleep strategies; possible exposure to light/noise/temperature extremes in in home/neighborhood • Considered impact of after school activities/chores/family demands • Considered caregivers’ challenges with setting limits on electronics and with implementing consistent sleep schedule • Considered caregiver work schedules; utilize other family members for support • Used term “motivator” rather than “reward” as more culturally acceptable, particularly in PR • Identified motivators that are in line with family goals/values (e.g., movie night, a game)
Group Session 2	• Learn to distinguish beneficial versus negative sleep hygiene behaviors. • Understand how napping affects sleep schedules and learn strategies for avoiding afternoon naps that disrupt sleep schedule consistency. • Identify characteristics of healthy and unhealthy sleep spaces. • Review purpose of tracking sleep to improve sleep duration and consistency.	• Red Light/Green Light game (healthy vs. unhealthy sleep hygiene behaviors) • Animated video activity: Characteristics of healthy vs. unhealthy sleep environments consistent with urban setting • Discuss causes and consequences of napping • Sleep disruptors activity (brainstorm strategies to manage night wakings) • Remind students to track progress toward sleep goals • To Do List (homework)	• Ensured that videos were culturally representative • Acknowledged cultural acceptability of napping • Considered napping as a behavior that may emerge to mitigate effect of inconsistent sleep schedules • Integrated common barriers to healthy sleep habits in sleep space • Integrated child feedback on activity/video activities
Follow Up Phone Call #1	• Provide an opportunity for family/child to obtain support and guidance regarding barriers encountered and encouragement to continue implementing goals identified during home visit. • Assess and revise sleep hygiene improvement goals as appropriate.	• Review child’s sleep parameters since last contact (based on electronic daily sleep assessment) • Remind caregiver of family’s sleep goals and identify any that have been challenging • Engage in collaborative problem solving with caregiver as necessary	• Integrated feedback from caregivers that they preferred follow ups about their child’s progress and to receive additional guidance on problem solving strategies to enhance sleep goals if needed
Group Session 3	• Demonstrate an understanding of the importance of keeping a regular sleep schedule. • Identify helpful vs. problematic bedtime routines. • Understand how electronics can make it more difficult to fall asleep and learn strategies to minimize the effects of electronics on sleep. • Learn strategies to avoid unhealthy sleep behaviors.	• Sleep Hygiene vignettes including urban Latino children (identify/problem solve common challenges to sleep hygiene) • Consistent sleep schedule activity (interpret graphs) • Discussion of bedtime routines • Blogging activity (decreasing electronics at bedtime) • Sleep Smart Strategies activity (managing social pressures that challenge sleep hygiene) • To Do List (homework)	• Ensured that vignettes were culturally representative • Integrated child feedback on all activities • Considered multiple family members who can assist in supporting sleep routines/schedules
Follow Up Phone call #2	• Provide an opportunity for family/child to obtain support and guidance regarding barriers encountered and encouragement to continue implementing identified goals. • Assess and revise sleep hygiene improvement goals as appropriate	• Review child’s sleep parameters since last contact (based on electronic daily sleep assessment) • Remind caregiver of family’s sleep goals and identify any that have been challenging • Engage in collaborative problem solving with caregiver as necessary	• Integrated feedback from caregivers that they preferred follow ups about their child’s progress and to receive additional guidance on problem solving strategies to enhance sleep goals if needed
Group Session 4	• Review the effects of caffeine on sleepiness and alertness. • Demonstrate understanding of healthy sleep hygiene behaviors in afternoon routine decision making activity. • Prepare to share and present new knowledge and healthy sleep hygiene behaviors to caregivers at home as part of the final home visit session.	• Discuss effects of caffeine • Caffeine Game (identify hidden sources of caffeine) • Activity: Design a Sleep Smart afternoon (integrate information learned throughout Project SIESTA) • Review material learned in program and prepare to share with caregiver	• Impact of Caffeine on Sleep/Review Caffeine in many common drinks and foods/snacks/Alternative beverages/snacks • Included caffeinated products that are more common in PR • Integrated child feedback on all activities
Home Visit 2	• Review what the child has learned about sleep during group sessions. • Review progress towards goals identified in home visit 1 and subsequent phone follow ups. • Learn strategies to continue to work towards identified goals, and to maintain progress over time. • Learn strategies to address challenges related to consistent sleep hygiene practices that families experience during weekends, vacations and the summer months. • Understand developmentally appropriate parent/child collaboration strategies to achieve quality sleep. • Support caregiver and child to communicate and resolve disagreements related to sleep behaviors.	• Knowledge review about sleep, assisted by child • Child’s current sleep patterns since the last Home Visit (from electronic daily sleep assessment) are reviewed visually with family • Facilitator uses these data to help family reflect on their progress toward goals for sleep duration, sleep hygiene, and sleep environment • Anticipate and problem solve barriers • Discuss ways to maintain progress	• Integrated barriers to sleep hygiene reflective from those commonly shared by caregivers (e.g., how to keep child on track when they are working late hours, or have late family events, how to adjust bedtime routines when children have family chores, how to integrate back and forth with family trips to PR on sleep schedules) • Caregivers shared having reminders of how to maintain sleep strategies would be helpful

Figure 2.

SIESTA Intervention Sessions

Identify Refinement Targets and Information Gathering.

We then identified refinement targets to apply to intervention components. First, we aimed to ensure that the SIESTA intervention sessions would be culturally and contextually tailored to be consistent with the beliefs, characteristics, and behaviors of Latino families. Information gathering efforts, described below, allowed us to address this refinement goal. Tailoring focused on identifying shared experiences of urban living and cultural processes relevant to many Latinos. Given many Latinos share a more collectivistic than individualistic worldview,³⁹ an emphasis on allocentric (group-based) goals framed the treatment approach for enhancing sleep hygiene (e.g., “working as a team” with family members to support healthy sleep habits). Group administration and caregiver involvement also was used to enhance students’ comfort and capitalize on the value of collectivism.^40,41

Intervention content also considered RI caregivers’ acculturation level, language proficiency, cultural traditions relevant to many families, and how these factors may interact with sleep behaviors.^10,11,13,42 For example, for the Healthy Sleep Behaviors Overview (see Table 1), we explored students’ beliefs about healthy sleep behaviors, with consideration of how family members can support them. When role- playing healthy bedtime routines, we considered student’s home environment and how family members can support consistent bedtime routines.

In prior work, although we found more commonality in cultural characteristics within Latino subgroups in RI, and between Latino groups in RI and PR,⁴³ we planned to integrate any ethnic subgroup or site differences in the intervention content and evaluate differences in intervention effects by site and by sub-ethnic group within RI. Of note, most RI Latino families are from PR or Dominican backgrounds, and we previously found no Latino subgroup differences in sleep hygiene or duration.¹⁶ Many families; however, have unique immigration, acculturation and historical experiences related to country of origin¹⁶ that may impact family’s sleep settings and routines. Thus, cultural stress was considered in the RI site’s curriculum; we incorporated how consistent sleep behaviors can be supported while adapting to a new setting.

Intervention content was also adapted to enhance contextual relevance. We identified urban stressors disrupting sleep (e.g., crowding, noise^10,44), to be integrated into intervention modules, highlighting problem solving strategies within family’s control that allow for addressing or “living with” stressors in a sleep-healthy manner. We included content-specific material for mainland (e.g., language barriers), and Island Latino children (e.g., strategies for addressing exposure to changes in light, excessive caffeine use). Although urban poverty and limited school-based resources were more pronounced in the targeted PR districts (e.g., more extended family living in home, higher levels of crime^45,46), these differences did not necessitate altering the main objectives of each session by site. An additional refinement goal included enhancing caregiver involvement throughout the intervention components given their central role in supporting sleep strategies in middle schoolers.⁴⁷ We added two home visits and two telephone check-ins involving caregivers (see Figure 2).

A final refinement goal involved enhancing the intervention school’s involvement and delivery. As part of the information gathering component of Stage 1 and to minimize barriers during school administration, we implemented a series of meetings with school staff at each site. We reviewed logistical details that were critical to the intervention’s success (e.g., how to market the program to families, location of administration, time of day, a school point-person). This information was applied to a procedural “go live” document to prepare for intervention delivery.

In addition to integrating prior results from the literature, we implemented in depth interviews and focus groups to address refinement goals and integrated results from these methods into intervention components. Briefly, we conducted 26 in depth interviews (13 in both sites; 6 in English, 7 Spanish in RI) given the paucity of research on sleep beliefs, behaviors, and routines important to urban Latino caregivers of middle schoolers. Questions focused on assessing sleep-related challenges and resources that may affect children’s sleep behaviors, including family routines and sleep environments, caregiver perceptions about sleep disruptors, barriers and motivators for participating in a family-based sleep intervention, and feedback regarding home-visit procedures.

Key themes from caregiver interviews at each site were integrated into relevant intervention components using a rapid qualitative analysis approach consistent with qualitative methods suggested for tailoring in the context of time constraints.^48,49 Interviews were summarized into executive summaries independently by at least 2 staff members by review of interview notes, debrief forms, and recordings. The qualitative team reviewed summaries and resolved any discrepancies. Using a priori areas and emergent data, thematic analysis was used to identify and summarize main responses. Content was summarized in English for each site into a framework matrix. During cross-site meetings with study investigators, with a table of refinement goals and intervention objectives for each session, we integrated prevalent themes from the in-depth interviews into working drafts of the refined intervention components and activities, and procedures (See Table 1 for examples). Intervention manuals and procedures were then translated into Spanish by the PR team using standard procedures.⁵⁰ Staff added appropriate visuals to intervention components across formats (manual, slides, figures) to enhance engagement.

We then conducted three, 1 ½ hour focus groups (per site; n=5 per group); one with middle schoolers in the targeted districts, and two with caregivers of middle schoolers (in RI, 1 with Spanish speaking and 1 with English speaking caregivers). Eligibility requirements aligned with those of the pilot RCT (see below). Focus group questions were developed for participants to provide feedback on specific content and activities within each session and on the delivery approach. Feedback focused on the helpfulness of specific intervention components, the ease of comprehension of session content, and how to better engage students and their caregivers (see Table 1 for examples).

Stage 2: Preliminary Adaptation Prior to Open Trial

To further prepare for the open trial, the cross-site Investigative team reviewed prevalent themes that emerged from each focus group to finalize the first draft of the tailored manualized intervention and procedures. Procedures for analysis, summarization and integration of focus group data into the intervention mirrored procedures of the in-depth interviews, as described above. Themes from each focus group question were summarized into a table to ensure participants’ feedback was integrated into relevant components of the SIESTA intervention and procedures to be used during the open trials at both sites.

Summary of SIESTA Intervention.

SIESTA is a culturally and contextually tailored sleep hygiene intervention aimed at improving sleep duration for urban Latino middle school children (Table 1). SIESTA involves four 60-minute group sessions administered in the middle school setting with students, and two 90-minute caregiver-child sessions delivered in the home (following the 1^st and 4^th school-based group sessions; Figure 1). During group sessions, children participate in interactive learning activities about sleep to foster engagement and group participation. During family sessions, children share with caregivers what they have learned and develop specific goals for sleep duration/timing, sleep hygiene, and their sleep environment. Barriers and resources that may affect these goals collected during an enrollment visit are reviewed by the facilitator prior to the first caregiver-child home visit to inform goal development and tailored sleep strategies. Brief phone check-ins with caregivers occur after group sessions 2 and 3 to discuss progress with sleep goals and problem-solve barriers.

After group session one, caregivers respond to daily sleep questions about their child, including sleep parameters (bedtime, rise time, and night wakings) and sleep behaviors (napping, timing/use of electronics and caffeine). A link is sent to the caregiver’s cell phone via text (through a customized Qualtrics program), with the option of responding to a series of SMS texts or a link to a survey on the internet. These data are summarized visually and presented by the facilitator using customized figures to display the child’s actual bedtimes/waketimes to their sleep goals, during caregiver-child sessions. Barriers to sleep goals and strategies to optimize progress are discussed (see Figure 2).

Facilitator Training and Fidelity.

To ensure training consistency across sites, identical training procedures were used. Graduate student interns in psychology, public health, and medical training programs at local universities were recruited to serve as facilitators for the intervention, allowing for the future creation of a sustainable dissemination model linking professional training opportunities in the community to neighboring universities. The overall training objectives were for facilitators to understand the intervention content, be comfortable with and confident to deliver the intervention, and to ensure that procedures were consistent across participants and groups. Eight 1.5-hour workshops were led by study investigators at both sites. This training plan was guided by our previous health intervention programs.^38,51 The training curriculum reviewed: a) goals of the proposed research, b) the nature of research and intervention work, c) consequences of inadequate sleep, importance of sleep hygiene, and barriers to appropriate sleep hygiene, d) skills for conducting groups and maintaining child engagement, e) skills for engaging both caregiver and child during family sessions, f) risk guidelines, g) behavioral management strategies, and h) the content of each session. Each facilitator role played sessions with mock participants (10+ hours per facilitator). To standardize training across sites, the PR and RI teams met regularly via zoom to observe these role plays. Trainers observed (or reviewed audiotape of) each facilitator’s first set of live sessions, as well as a random sample of 15% of subsequent sessions. During the intervention, weekly group supervision was provided to review and prepare for specific sessions and discuss facilitation issues. During the Open Trial and RCT, Research Assistants observed intervention sessions and rated facilitators on an adherence scale covering elements of each session. Fidelity scores were generated by dividing the number of covered elements by the total number of session elements; fidelity scores below 85% triggered discussion during supervision.

Stage 3. Open Trial

We enrolled 5 middle school children (3 in RI and 2 in PR) in an open trial to test the preliminary adaptation and acceptability and feasibility of SIESTA. We used the same recruitment procedures and eligibility/exclusion criteria as the pilot RCT (see Methods of Pilot RCT below). We administered all components of SIESTA as described in Figure 2 at each site by co-facilitators (2 per site). During exit interviews following each session, we assessed the content and flow of the sessions, how well each session was received, the effectiveness of the format and training procedures/manual, and the feasibility of recruitment procedures, inclusion/exclusion criteria, facilitator training and intervention procedures. Co-facilitators and intervention study staff took notes during the administration process regarding barriers to procedures, intervention delivery, and specific intervention components that were challenging to administer or perceived to not be received well by participants.

Stage 4. Adaptation Refinement Prior to Pilot RCT

The Investigative team then integrated results from exit interviews conducted after each session during the open trial. Research assistants queried children and caregivers about their experiences after each session, asking about which aspects of the sessions they would recommend being improved, whether specific components were helpful, and the usefulness of specific interactive activities. Both participants and co-facilitators were queried about the adequacy, length, order, and clarity of the sessions. Results and feedback were summarized by session into a table, and evaluated by the Investigative team to integrate into the finalized treatment procedures, the intervention manual, and training materials. Intervention adaptations were then translated and finalized for the pilot RCT.

Stage 5: Pilot Randomized Control Trial

A cross-site pilot RCT using the final SIESTA intervention manuals and procedures was then administered to test whether SIESTA would improve sleep hygiene and sleep duration in a sample of 34 Latino, middle school-aged children (12 in RI and 22 in PR; 17 randomized to each condition). After baseline, students were randomly assigned either to 1) SIESTA, or the 2) Sleep Education plus Child Health control condition (2 groups per condition for each site). We expected participants randomized to SIESTA to have a greater increase in sleep duration and improved sleep hygiene behaviors than those in the attention control condition.

Methods of Pilot RCT: Study Participants.

The sample included urban and Latino 6th, 7th, and 8th grade children (11–13 years old) and their primary caregivers recruited from urban middle schools in the Greater Providence and San Juan area. Inclusion criteria for middle school students specified that child participants must a) be between the ages of 11–13, b) be in 6th-8th grades, c) attend a school within one of the targeted public-school districts, and d) have sleep duration < 9 hours by caregiver report. This sleep duration cut-point was chosen a) based on the average sleep duration found in prior studies including urban children of this age group,^13,52 b) because it is below recommended sleep duration for this age group^53,54 and c) <9hrs of sleep is linked with poor health outcomes.^55,56 Caregivers were asked over the phone: What time does your child usually: a) fall asleep on weekdays, b) wakeup on weekdays? Further, in RI, children’s primary caregiver needed to self-identify as Latino and be able to speak English or Spanish. We delivered the intervention in RI schools in English as the majority of Latino children speak English in the targeted schools. Exclusion criteria included: significant developmental delay, and/or severe psychiatric or chronic medical condition that would preclude study completion or confound analyses. We excluded those whose caregivers reported a current/prior sleep disorder diagnosis (e.g., sleep disordered breathing) through the use of a well-validated caregiver assessment at screening.⁵⁷

In RI, we included children from all Latino ethnic subgroups, as there is a need for sleep interventions tailored for many Latino children. The majority of RI Latinos are Puerto Rican or Dominican, with growing numbers of Central and South Americans.⁵⁸ Including all Latino ethnic subgroups will enhance the intervention’s generalizability and prepare us to disseminate it in a larger RCT.^43,59

Control Condition: Sleep Hygiene Education and Child Health.

We compared SIESTA to an attention control condition that involved basic sleep hygiene education and integrated child health topics, such as nutrition, physical activity, and safety, found in previous work to be of interest to Latinos.³⁸ We considered its content to ensure that it a) was equivalent in contact time to SIESTA, b) was credible and of interest to students, and c) would exert limited treatment effects as it did not involve sleep behavioral approaches effective with this age group, and include content tailored for urban Latinos. A BA-level facilitator from the community delivered the control intervention.

Recruitment Strategy and Procedures.

We enrolled 34 children across both sites (see Figure 4). Seventeen children were randomized to SIESTA and 17 to the Attention Control condition (in RI, 7 to SIESTA, and 5 to attention control; in PR, 10 to SIESTA, and 12 to the attention control). We implemented 2 sets per site (a set is a treatment and attention control condition and had 5–8 children per group).

Figure 4.

SIESTA Consort Diagram

Recruitment sites were urban public middle schools (2 in greater Providence, RI, 2 in San Juan, PR), environmentally similar to one another within each study site. We targeted the larger urban public middle schools with 6^th-8^th graders, and in RI those with the highest proportion of Latino students. Most (80–90%) students were “economically disadvantaged.” Emails introducing the program were sent from each school to families from their respective school administrators. We received approval from the IRB for the current study and support and necessary approvals from the district schools involved in the research. Families were called and provided information about the program. If found eligible, interested primary caregivers and child participants provided verbal and written consent and assent to take part in the study during the enrollment visits.

COVID-19 and Adaptation to Remote Delivery.

In March of 2021 adaptation of the SIESTA program to remote delivery (i.e., via Zoom platform) was needed due to COVID-19. Adaptation occurred after administration of the open trial in RI. All school-based group sessions henceforth occurred remotely, with the children attending from home (as school was not occurring in person). Caregiver-child home-based sessions were also adapted to remote delivery, including an interview-based, home-environment assessment that replaced the walk-through of children’s sleep environment. These adaptations did not change each session’s objectives; rather we focused on adapting activities that could not be implemented remotely. For example, to replace an in-person group activity in which children drew a healthy sleep environment, a remote activity was devised in which children viewed short animations of sleep environments and were asked to identify the healthy and less healthy aspects of them. Adaptation also involved devising remote delivery procedures to enhance participant engagement and troubleshoot technological challenges. We ensured families had internet access and provided a training slide show of technological features to be used during remote delivery (e.g., use of the secure link, features of Zoom to enhance engagement and interaction, such as polling, white board, hand raising, chat feature, etc.), as well as “Zoom etiquette” (e.g. muting when not speaking, keeping camera on, etc.).

All intervention and research session administration for the pilot RCT occurred during the academic year. Eligible middle school students and their caregiver completed a baseline assessment remotely via an online platform (Zoom). Two weeks after baseline (allowing for monitoring sleep quality), participants were randomized to the SIESTA or attention control condition (see Figure 3). The child group and caregiver- child sessions occurred remotely. After treatment completion (end of the last child-caregiver session), children and caregivers completed an end of treatment (EOT) assessment, including repeated assessment of baseline measurements. A 4-month follow-up replicated the EOT assessment. Randomization occurred at the child-level after baseline at the participant level.

Figure 3.

Pilot RCT and Intervention

Measures

Demographics.

Caregivers provided information about children and caregivers’ age, ethnicity, gender, level of education, household income, and marital status using an interview- based assessment from prior work.¹³

Sleep Duration.

Children’s sleep duration (total sleep time from start to end) was assessed via the Actiwatch Spectrum (Phillips Respironics, Pittsburgh, PA, USA). Children wore the Actiwatch on their non-dominant wrist for 2 weeks during baseline, EOT, and 4-month follow-up periods. We used standardized and manualized procedures to score actigraphy data as detailed in our previous publications.⁵²

Sleep Hygiene.

Caregivers completed the Children’s Sleep Hygiene Scale⁶⁰ to report on physiological, cognitive, emotional, environmental, and behavioral factors affecting children’s sleep hygiene in the past two weeks. Caregivers also completed the PROMIS v.1.0 Sleep Disturbance measure⁶¹ to rate the frequency of child’s sleep difficulties in the past week. Children completed the Adolescent Sleep Wake Scale¹⁷ to report on their sleep hygiene behavior.

Exit Interviews and Fidelity Assessments.

Caregivers and children were interviewed at the end of treatment to assess their perception of intervention acceptability. Staff members assessed adherence to all intervention components.

Analysis

A series of generalized linear models were used to examine between-group differences in change in objective measures of sleep duration and self-reported outcomes. Interest was in estimating the magnitude of within-group changes in these measures over time, as well as estimating differences between treatment groups over time. In all cases, within-group effect sizes have been reported as d (d=.5 considered a medium sized effect). Summary statistics for treatment fidelity are reported in Table 2.

Table 2.

Treatment Fidelity

	Mean	Std Deviation	Min-Max
Group Session 1	10.42	.53	10–11
Group Session 2	9	0	9–9
Group Session 3	10	0	10–10
Group Session 4	7	0	7–7
Intervention Fidelity Home Visit 1	21	0	21–21
Intervention Fidelity Home Visit 2	18	0	18–18
Intervention Phone Fidelity	11	-	11–11

Results

Table 3 contains % change in objectively recorded sleep duration by group. Sleep duration increased by 13.3% (d=0.16) among SIESTA participants (from baseline to end of treatment) compared to 7.2% (d=0.14) among the attention control condition, p=.04. These differences were even greater at follow-up with percent change in sleep duration from baseline to follow-up being 14.9% (d=0.75) among SIESTA participants compared to 1.4% (d=.03) among attention controls, p<.01.

Table 3.

Changes in Objectively Recorded Sleep Duration by Group

	Baseline to EOT	Baseline to Follow-up
SIESTA	d=.16, % change=13.3%	d=.75, % change=14.9%
Child Health Attention Control	d=.14, % change=7.2%	d=.03, % change=1.4%

Caregiver and self-reported child sleep disturbances and hygiene behaviors (by group and time) are presented in Table 4. Results indicated greater improvements from baseline to EOT (34.18%/d=0.94 vs. 20.43%/d=0.69), and baseline to follow-up (28.89%/d=0.75 vs. 17.52%/d=0.52) in the PROMIS measure, reflecting a decrease in sleep disturbances, for SIESTA vs. attention controls (p’s<.04). Further, there were greater improvements from baseline to EOT and baseline to follow-up in the Child Sleep Hygiene Scale and Adolescent Sleep Wake Scale for SIESTA vs. controls (p’s<.05).

Table 4.

Changes in Self- and Caregiver- Reported Sleep Disturbances and Sleep Hygiene by Group

	Baseline	EOT	Baseline to EOT (% differences baseline to EOT)	Follow-up	Baseline to Follow-up (% differences baseline to follow-up)
PROMIS
SIESTA	17.41(8.16)	11.46(3.76)	34.18%, d=.94	12.38(4.87)	28.89%, d=.75
Attention Control	15.47(4.56)	12.31(4.59)	20.43%, d=.69	12.76(5.83)	17.52%, d=.52
Child Sleep Hygiene Scale
SIESTA	3.98(.64)	4.53(.71)	−13.8%, d=.77	4.56(.80)	−14.5%, d=.73
Attention Control	4.08(.68)	4.29(.65)	−5.1%, d=.32	4.28(.65)	−4.9%, d=.02
Adolescent Sleep Wake Scale
SIESTA	4.24(1.11)	4.74(1.02)	−11.8%, d=.49	4.90(.91)	−15.6%, d=.73
Attention Control	4.62(.70)	4.72(.95)	−2.2%, d=.11	4.77(.97)	−3.2%, d=.15

Finally, 100% of participants in the SIESTA intervention arm reported being at least “somewhat satisfied” with the intervention (79% reported being very satisfied and 21% reported being somewhat satisfied), indicating the intervention was acceptable. Treatment fidelity results are summarized in Table 2, revealing high adherence to all intervention components across conditions as rated by study staff at both sites.

Discussion

Although efficacious school-based sleep hygiene programs exist, they are not tailored for urban Latino middle schoolers. The current paper describes systematic efforts to culturally and contextually tailor a sleep hygiene intervention to enhance relevance and feasibility for delivery to Latino urban middle school children in two urban settings with a high prevalence of Latinos: Providence, RI and San Juan, PR. We described steps taken to refine an intervention that utilized behavioral sleep hygiene approaches appropriate for this age group and a five -step adaptation approach based on Barrera and colleagues (Figure 1). These systematic efforts allowed us to enhance: a) SIESTA’s cultural and contextual relevance across the two sites, b) its specificity to the school setting in both sites, and c) to build on the caregiver component to enhance its applicability with Latino children. The approach appeared to amplify the effects of our original intervention to improve sleep duration and sleep hygiene in our targeted sample, as demonstrated by the findings of the pilot randomized controlled trial.

Specifically, results through objective methods showed that SIESTA has promise for improving sleep duration in children more so than in those who participated in our attention control condition. Further, children assigned to SIESTA and their caregivers reported fewer sleep disturbances and more optimal sleep hygiene behaviors than their attention control peers. Caregiver and child feedback highlighted that participants found the SIESTA program useful and helpful for learning more about the importance of sleep and strategies to improve sleep.

SIESTA included unique features that may have contributed to its beneficial impact on sleep hygiene and duration. Aside from critical tailoring efforts to improve cultural and contextual relevance, the child-caregiver sessions allowed for review of key educational sleep messages that children learned in the group sessions, and development of sleep goals across three key domains sleep schedule, sleep environment, and sleep hygiene - with problem solving to address actual and anticipated barriers experienced during attainment of each goal. The use of the Qualtrix electronic sleep checklist allowed for critical daily information that informed clear visuals displaying actual effort and proposed goals during meetings with families, outlining progress and allowing for discussions on how to address challenges. Future work will pinpoint specific intervention components critical for improving sleep duration in a larger trial with the targeted population.

Several limitations should be considered and addressed in future work. COVID-19 posed as a challenge to intervention administration during periods with high infection periods and was certainly a confound to administering a sleep intervention during times when schools were closed and children were sleeping more. Waiting until children could resume their school schedule enhanced our ability to proceed with the SIESTA pilot RCT. We developed in-person and remote delivery versions of SIESTA and expect stronger intervention effects with the in- person sessions relative to remote; however, this needs to be tested in a future larger-scaled RCT to evaluate SIESTA’s effectiveness for improving sleep duration via the in-person intervention delivery approach and its generalizability.

Developing an effective sleep hygiene intervention is a critical first step toward our future goal of utilizing SIESTA to improve sleep duration and specific health outcomes in urban Latino youth, the fastest growing ethnic group in the US, with the highest prevalence of co-morbid chronic health conditions. This innovative sleep health intervention has potential for use as a standalone program to improve sleep, or it could be integrated with our evidenced-based disease management interventions. Inclusion of children, caregivers, and school staff and using several sources of data collection allowed for rich opportunities to garner feedback on sleep beliefs, family schedules, sleep disruptors in the child’s sleep environment, and family strengths than challenge and support children’s sleep duration. A phased approach including information gathering and adaptation, followed by an open trial, then a pilot of the finalized SIESTA intervention in an RCT helped to enhance the preliminary efficacy of SIESTA and can be a useful approach for culturally and contextually tailoring sleep health interventions for specific populations. Future research will evaluate SIESTA during a larger trial across both sites in similar urban settings with Latino children and their families. This paper also highlights the critical need for further research and development of sleep health interventions that meet the sleep needs of specific populations and contribute to their overall health and well-being.

Data

The dataset analyzed in the current study is available from the corresponding author upon reasonable request.