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Randomized Controlled Trial
. 2022 Apr 1;18(4):1153-1166.
doi: 10.5664/jcsm.9822.

Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care

Ariel A Williamson  1   2 , Chimereodo Okoroji  1 , Olivia Cicalese  1 , Brittney C Evans  3 , Amanda Ayala  1 , Bethany Harvey  1 , Rachel Honore  1 , Amy Kratchman  1 , Rinad S Beidas  2   4   5 , Alexander G Fiks  1   2 , Thomas J Power  1   2 , Jodi A Mindell  1   2   6
Affiliations
Randomized Controlled Trial

Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care

Ariel A Williamson et al. J Clin Sleep Med. .

Abstract

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.

Keywords: health disparities; insomnia; intervention; pediatric; primary care; sleep health.

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Conflict of interest statement

Dr. Williamson was supported by the Sleep Research Society Foundation and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (K23HD094905). Dr. Fiks is the co-inventor of decision support software known as the Care Assistant; he has earned no income and does not hold a patent from this invention. In the past, Dr. Fiks received an independent research grant from Pfizer that supported his research team but did not support his salary. Dr. Beidas receives royalties from Oxford University Press, has served as a consultant to the Camden Coalition of Healthcare Providers, currently serves as a consultant to United Behavioral Health, and serves on the Clinical and Scientific Advisory Committee for Optum Behavioral Health. The remaining authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Overview of study design.
See Williamson et al for initial qualitative inquiry results. See Table S1 for a description of each advisory board. (a) = clinician advisory board, (b) = family advisory board, (c) = expanded clinical advisory board.
Figure 2
Figure 2. Participant recruitment, enrollment, and retention.
*One family participated in the previous qualitative study. COVID-19 = coronavirus disease 2019.
Figure 3
Figure 3. Summary of peripheral and core adaptations made throughout intervention adaptation and testing.
COVID-19 = coronavirus disease 2019
Figure 4
Figure 4. Intervention acceptability and cultural humility ratings.
(A) Intervention acceptability ratings at postintervention (n = 12). (B) Cultural humility ratings at postintervention (n = 10).
See this image and copyright information in PMC

Comment in

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