Clinical Trial

The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers

Recruiting
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Record status
This record was last updated December 27, 2024 (before its estimated May 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-12-11; most recent amendment 2024-12-23.
Trial Details
NCT Number NCT06737055
Lead Sponsor Rhode Island Hospital
Collaborators: Bradley Hospital
Conditions Sleep, Postpartum Depression, Pregnancy Related, Insomnia, Sleep Deprivation, Sleep Hygiene, Sleep Disturbance
Enrollment 55 participants
Start Date 2023-08-08
Primary Completion 2025-05-31 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-27