No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
55 (estimated)
Sponsor
Rhode Island Hospital · Other
Who this trial is looking for
This trial is looking for expectant mothers or new parents who have difficulty sleeping. Participants will learn about a sleep program designed to help manage their sleep issues during and after pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I am a new parent or expecting a baby.
I am between 18 and 45 years old.
I am receiving community-based health or mental health services.
I speak and read English or Spanish.
I have access to a smartphone.
I have significant sleep difficulties.
You may not be able to join if
My infant does not live at home with me.
I have a nighttime caregiver for my infant.
I already have a specialty in perinatal sleep.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 s…
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.
Trial Locations
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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 ex…
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.
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