Recruiting

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

ClinicalTrials.gov IDNCT06737055

PhaseNA

Enrollment55

SponsorRhode Island Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

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.

Primary outcomes

Phase 1 Reach (Throughout training period, i.e., for about 6 months; one time measure.)
Phase 1 Effectiveness (At enrollment and 1 month after training.)
Phase 1 Acceptability (1 month after training)
Phase 2 Reach (one time measure during enrollment period, ~ 6 months)
Phase 2 Effectiveness (6 weeks after enrollment)
Phase 2 Effectiveness - Insomnia Severity Index (at enrollment and 6 weeks after enrollment)
Phase 2 Effectiveness - Implementation (from enrolllment through 6 weeks after enrollment)

Eligibility information

Phase 1 Inclusion Criteria: To qualify for Phase 1 enrollment, participants must be: * over 18 years of age; * working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community center); * in a role where they would be expected to meet with the same client on at least 4 occasions during the perinatal period; in situations where a team-based approach is used to provide services and a client may not see the exact same person at each visit, team members will qualify if they all enroll in the study (e.g., two nurse midwives who provide coverage for each other may both enroll); * have access to a smart phone to view the training videos, complete the assessments, and access the free CBTi Coach app; speak and read English or Spanish; * express interest in providing their clients with additional tools to manage sleep disturbances in pregnancy and the postpartum period. Phase 1 Exclusion Criteria: The investigators will exclude potential participants who: * already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching practices); * those who do not have longitudinal relationships with clients (e.g., intake workers). Phase 2 Inclusion Criteria: To qualify, Phase 2 participants must be: * expectant parents OR new parents up to 1 year postpartum; * age 18 to 45 years old; * receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1; * speak and read English or Spanish; * have access to a smart phone to view the training videos and complete the assessments; * have clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7. Phase 2 Exclusion Criteria: The investigators will exclude potential participants whose infants will not be living in the home or who will have a nighttime caregiver.

Study locations

Rhode Island Hospital, Providence, Rhode Island 02903 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.