The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
Key facts
- Who runs it
- Rhode Island Hospital
- Where
- Providence, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 55 people, planned
- Started
- 8 Aug 2023
- Planned end
- 30 Jun 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Education about behavioral strategies to improve sleep
- Record updated
- 27 December 2024
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Other 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in United States
- Rhode Island HospitalProvidence, United StatesContact: Katherine M Sharkey, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Home VisitorsTreatment being tested
The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity.
Treatment: Education about behavioral strategies to improve sleep
- Expectant and New ParentsTreatment being tested
Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep. To qualify for enrollment, Phase 2 participants must be: * expectant parents OR new parents up to 1 year postpartum * 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 sleep diaries and assessments * are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver
Treatment: Education about behavioral strategies to improve sleep
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06737055, who can take part
- Record updated
- 27 December 2024