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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT06737055
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Education about behavioral strategies to improve sleep — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 8, 2023
Status verified
Dec 2024
Primary completion
May 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Home Visitors
    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.
  • Experimental: Expectant and New Parents
    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

Primary Outcome Measure

Phase 1 Reach [ Time Frame: Throughout training period, i.e., for about 6 months; one time measure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903
Katherine M Sharkey, MD, PhD
[email protected]
401-793-3497

Find similar trials in Providence, RI

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Rhode Island Hospital· Providence, RI

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