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

Rhode Island Hospital · with Bradley Hospital · NCT06737055

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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
All sleep studies in Rhode Island →
The Dream Team: Testing Implementation of a Sleep Intervention for… (NCT06737055) | Bored Studies