Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID06737055

The Dream Team: Testing a Behavioral Sleep Intervention for Expectant and New Mothers Delivered by Direct Care Workers

Led by Rhode Island Hospital · Updated on 2024-12-27

55

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

Sponsors

R

Rhode Island Hospital

Lead Sponsor

B

Bradley Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Disrupted and insufficient sleep is common among pregnant women and can lead to negative health outcomes for both mothers and their infants, including complications during pregnancy and childbirth as well as chronic illnesses like major depression and obesity. This research aims to develop and test a behavioral sleep intervention designed specifically for expectant and new mothers, delivered by direct care workers. The study follows the RE-AIM framework to evaluate how well this intervention can be implemented and maintained in community settings. The study consists of two phases. Phase 1 involves creating and refining short educational videos about improving perinatal sleep, which accompany a free behavioral sleep app called CBTi Coach. These videos are developed with input from direct care workers and a video production company to ensure they are engaging and relevant. Direct care workers who support perinatal women are trained to deliver this intervention. In Phase 2, these trained workers use the intervention with expectant and new parents who have sleep difficulties, and the researchers study how well the intervention reaches and benefits the participants. Participants in the study will be involved in viewing the training videos and using the sleep app. Researchers will collect data on various outcomes including how many people the intervention reaches, its effectiveness in improving sleep, acceptability to users, and how well it is implemented and maintained over time. Assessments include measures taken at enrollment, one month, six weeks, and throughout the training period, with questionnaires such as the Insomnia Severity Index. The study monitors both direct care workers and their clients over approximately six months to gather comprehensive data on the intervention's impact and feasibility.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Phase 1 participants must be over 18 years old
  • Phase 1 participants must work with expectant and new mothers in community settings
  • Phase 1 participants must have roles involving at least 4 meetings with the same client during the perinatal period or be part of a team where all members enroll
  • Phase 1 participants must have access to a smartphone and speak English or Spanish
  • Phase 1 participants must be interested in providing clients with tools to manage sleep disturbances
  • Phase 2 participants must be expectant or new parents up to 1 year postpartum
  • Phase 2 participants must be 18 to 45 years old
  • Phase 2 participants must receive community-based health or mental health services from Phase 1 participants
  • Phase 2 participants must speak English or Spanish
  • Phase 2 participants must have access to a smartphone
  • Phase 2 participants must have clinically significant sleep difficulties (Insomnia Severity Index score > 7)
Not Eligible

You will not qualify if you...

  • Phase 1 participants with certification or specialty in perinatal sleep (e.g., CBTi therapists, sleep coaches) are excluded
  • Phase 1 participants who do not have ongoing relationships with clients (e.g., intake workers) are excluded
  • Phase 2 participants whose infants will not live in the home or who will have a nighttime caregiver are excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

Loading map...

Research Team

K

Katherine M Sharkey, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

The Dream Team: Testing a Behavioral Sleep Intervention for Expectant and New Mothers Delivered by Direct Care Workers | DecenTrialz