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

Launched by RHODE ISLAND HOSPITAL · Dec 11, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Home Visitors Sleep Diaries Education Implementation Re Aim

ClinConnect Summary

This clinical trial, called "The Dream Team," is focused on helping expectant and new mothers who are struggling with sleep issues, which can affect their health and well-being. The study will test a special sleep program that includes short videos and a free app designed to improve sleep habits. In the first phase, the researchers will work with care workers who support pregnant and new mothers to develop this program. In the second phase, these care workers will use the program with mothers experiencing sleep difficulties to see how well it works and how it can be maintained over time.

To take part in the trial, participants must meet certain criteria. For Phase 1, care workers need to be over 18 and work directly with expectant or new mothers in community settings, like clinics or home visiting programs. For Phase 2, new or expectant mothers aged 18 to 45 who are experiencing significant sleep problems and are receiving community-based health services can participate. Participants can expect to engage with helpful training materials and resources aimed at improving their sleep quality. This trial is an exciting opportunity to address sleep challenges during a crucial time in a mother’s life!

Gender

ALL

Eligibility 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.

About Rhode Island Hospital

Rhode Island Hospital, a leading academic medical center and a key component of the Lifespan health system, is committed to advancing medical research and improving patient care through innovative clinical trials. As a principal teaching hospital for The Warren Alpert Medical School of Brown University, it integrates cutting-edge research with high-quality clinical services. The hospital's extensive clinical trial program spans various fields, including oncology, cardiology, neurology, and more, aiming to enhance treatment options and patient outcomes. By fostering collaboration among researchers, clinicians, and patients, Rhode Island Hospital plays a pivotal role in translating scientific discoveries into effective therapies and improving healthcare delivery.

Locations

Providence, Rhode Island, United States

Patients applied

0 patients applied

Trial Officials

Katherine M Sharkey, MD, PhD

Principal Investigator

Rhode Island Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported