RESUMEN
STUDY OBJECTIVES: To describe the adaptation, feasibility, and initial outcomes of Sleep Well!, an intervention for early childhood insomnia and insufficient sleep, designed for families from lower-socioeconomic status backgrounds presenting to large metropolitan primary care sites. METHODS: 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 in this multimethod, single-arm trial. 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. Most adaptations were related to intervention delivery methods, with some related to sleep strategies. 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. RESULTS: Thirteen (86.6%) families completed Sleep Well! and 12 (80.0%) completed pre- and postintervention measures. Caregivers reported strong intervention acceptability and cultural humility. There were preintervention to postintervention 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. Qualitative data also showed strong intervention acceptability and perceived flexibility, with few participation barriers. CONCLUSIONS: A brief, early childhood behavioral sleep intervention delivered in primary care with families from primarily lower-socioeconomic status 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. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Implementing Behavioral Sleep Intervention in Urban Primary Care; URL: https://clinicaltrials.gov/ct2/show/NCT04046341; Identifier: NCT04046341. CITATION: Williamson AA, Okoroji C, Cicalese O, et al. Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care. J Clin Sleep Med. 2022;18(4):1153-1166.