Testing a sleep intervention for expectant and new mothers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and pilot a behavioral sleep intervention for perinatal women, addressing the common issue of disrupted sleep during pregnancy and postpartum. The intervention includes educational videos designed to accompany a free behavioral sleep app, with input from direct care workers who support at-risk mothers. The project will be conducted in two phases: the first focuses on refining the intervention, while the second involves direct care workers delivering the training to mothers and assessing the intervention's effectiveness and scalability. The study is grounded in the RE-AIM framework to evaluate its reach, effectiveness, adoption, implementation, and maintenance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Katherine M Sharkey, MD, PhD — Rhode Island Hospital
• Study coordinator: Katherine M Sharkey, MD, PhD
• Email: katherine_sharkey@brown.edu
• Phone: 401-793-3497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.