NCT06737055

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).

Conditions

• Sleep
• Postpartum Depression
• Pregnancy Related
• Insomnia
• Sleep Deprivation
• Sleep Hygiene
• Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Education about behavioral strategies to improve sleep	In collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period.

Timeline

• Start date: 2023-08-08
• Primary completion: 2025-05-31
• Completion: 2025-06-30
• First posted: 2024-12-17
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States