The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
Rhode Island Hospital · with Bradley Hospital · NCT06737055
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–99 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 55
- US sites recruiting
- 1
- Study start
- August 8, 2023
- Record last updated
- December 27, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Education about behavioral strategies to improve sleep
Conditions: Sleep; Postpartum Depression; Pregnancy Related; Insomnia; Sleep Deprivation; Sleep Hygiene; Sleep Disturbance
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Rhode Island Hospital
Providence, RI 02903
Site contact: Katherine M Sharkey, MD, PhD · 401-793-3497 · katherine_sharkey@brown.edu
Study contacts (from the official record)
- Katherine M Sharkey, MD, PhD · 401-793-3497 · katherine_sharkey@brown.edu
Similar studies in Rhode Island
All sleep studies in Rhode Island →- RecruitingPhase 3
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
Merck Sharp & Dohme LLC
- Location
- Providence, RI + 12 other US sites
- Eligibility basics
- Ages 18–70
- RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Harmony Biosciences Management, Inc.
- Location
- East Providence, RI + 39 other US sites
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteers
A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
Rhode Island Hospital
- Location
- Providence, RI
- Eligibility basics
- Ages 11–13