RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-08
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06737055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * over 18 years of age;
  2. * working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community center);
  3. * 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);
  4. * 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;
  5. * express interest in providing their clients with additional tools to manage sleep disturbances in pregnancy and the postpartum period.
  1. * already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching practices);
  2. * those who do not have longitudinal relationships with clients (e.g., intake workers).

Contacts and Locations

Study Contact

Katherine M Sharkey, MD, PhD
CONTACT
401-793-3497
katherine_sharkey@brown.edu

Principal Investigator

Katherine M Sharkey, MD, PhD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Katherine M Sharkey, MD, PhD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • Home visitors
  • sleep diaries
  • education
  • implementation
  • RE-AIM

Additional Relevant MeSH Terms

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