Sleep Well! is a multi-phase study, consisting of (1) a qualitative inquiry focused on identifying key barrier and facilitators to adaptation and implementation of evidence-based behavioral sleep interventions, (2) iterative intervention adaptation, and (3) a randomized control trial (RCT) comparing Sleep Well! to enhanced usual care, intended to inform a future hybrid effectiveness-implementation trial.

Study #1: Adapting Evidence-Based Behavioral Sleep Intervention for Urban Primary Care

Summary: This qualitative study assessed caregiver and clinician perspectives to inform adaptation and implementation of evidence-based behavioral sleep interventions in urban primary care with families who are predominantly of lower SES. Semi-structured interviews with 23 caregivers (96% mothers; 83% Black; 65% ≤125% U.S. poverty level) of toddlers and preschoolers with insomnia or insufficient sleep and 22 urban primary care clinicians (physicians, nurse practitioners, social workers, and psychologists; 87% female; 73% White), were guided by the Consolidated Framework for Implementation Research. The qualitative interview data was analyzed using an integrated approach to identify thematic patterns of convergence and divergence in stakeholder perspectives. Participants agreed upon the importance of child sleep and intervention barriers. Participants tended to agree that interventions should be flexible, collaborative, and empower care, and that and caregiver-to-caregiver support and use of technology facilitate implementation. While clinicians identified many family barriers to treatment engagement, caregivers perceived few barriers. Clinicians also raised healthcare setting factors that could support (integrated care) or hinder (space and resources) implementation. Findings indicate adaptations to evidence-based early childhood sleep intervention that may be necessary for effective implementation in urban primary care, which could potentially reduce significant pediatric sleep-related health disparities.

Related Publications: Williamson, A. A., Milaniak, I., Watson, B., Cicalese, O., Fiks, A. G., Power, T. J., Barg, F. K., Beidas, R. S., Mindell, J. A., & Rendle, K. A. (2020). Early childhood sleep intervention in urban primary care: Caregiver and clinician perspectives. Journal of Pediatric Psychology, 45(8): 933-945. doi: 10.1093/jpepsy/jsaa024

+ Received the 2020 Diane J. Willis Award for Outstanding Article in the Journal of Pediatric Psychology

Funding Source(s): National Institute of Child Health and Human Development (K23HD094905); Career Development Award, Sleep Research Society Foundation

Stage: Completed

Study #2: Implementing Evidence-Based Behavioral Sleep Intervention in Urban Primary Care (Aim 2)

Summary: This multimethod, single-arm trial employed  community-engaged research methods to iteratively adapt and test Sleep Well!, an intervention for early childhood insomnia and insufficient sleep, designed for families from lower–SES backgrounds presenting to large metropolitan primary care sites. Fifteen caregiver-child dyads (caregivers: 92.3% mothers, 80.0% Black, 53.3% ≤ 125% US poverty level; children: 73.3% female, 86.7% Black, mean age = 3.0 years) participated. A family advisory board of caregivers (n = 4) and a clinician advisory board of sleep experts, primary care clinicians, and psychologists (n = 13) provided intervention feedback throughout the pilot. Adaptations, primarily relating to intervention delivery methods, were made after each round of feedback. At postintervention, caregivers completed surveys on intervention acceptability and cultural humility (primary outcomes) and completed semistructured interviews. Caregivers also reported on child sleep pre and postintervention. Caregivers reported strong intervention acceptability and cultural humility. There were reductions in child sleep problems, bedroom electronics, sleep onset latency, and night awakening frequency and duration. Nighttime sleep duration and overall insufficient sleep also improved. Result suggest that a brief, early childhood behavioral sleep intervention delivered in primary care with families from primarily lower-SES backgrounds and/or racially minoritized backgrounds is feasible to implement, with strong retention rates, acceptability, and perceptions of cultural humility. Child sleep improvements are positive and warrant replication in a randomized controlled trial.

Related Publications: Williamson, A. A., Okoroji, C., Cicalese, O., Evans, B. C., Ayala, A., Harvey, B., Honore, R., Kratchman, A., Beidas, R. S., Fiks, A. G., Power T. J., & Mindell, J. A. (2022). Sleep Well!: An adapted behavioral sleep intervention implemented in urban primary care. Journal of Clinical Sleep Medicine, 18(4): 1153-1166. doi: 10.5664/jcsm.9822. PMID: 34910624 PMCID: PMC8974371[AW1]

Funding Source(s): National Institute of Child Health and Human Development

CT.gov #: NCT04046341

Stage: Completed

Study #3: Implementing Evidence-Based Behavioral Sleep Intervention in Urban Primary Care: A Randomized Control Trial (Aim 3)

Summary: This randomized clinical trial (RCT) is a pilot study of Sleep Well!, a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The intervention, which includes evidence-based behavioral sleep approaches and strategies to engage and empower families, was implemented with caregiver-child dyads (child ages 1-5 years with a sleep problem) who were recruited from CHOP urban primary care sites. This RCT aims to (1) determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families and (2) examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention and follow-up.

CT.gov #: NCT04473222

Stage: Data analysis is ongoing

Mentors

Family Partners

Amanda Ayala

Kristina Boling-Smith

Bethany Harvey

Rachel Honore

Amy Kratchman

L’Vonne McMillan 

Study Coordinators

Olivia Cicalese, MS

Ebere Uwah, MD

Interventionists

Jae Ahn 

Margaret Crane

Mallory Garnett

Alison Hartman 

Chim Okoroji  

Yin Cai