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The Dream Team: Sleep Intervention for Perinatal Women

This study, called "The Dream Team," is testing a new way to help expectant and new mothers with sleep problems. Researchers are developing educational videos about healthy sleep habits, which will be shared by direct care workers (like home visitors) who support these mothers. The goal is to see how well this "behavioral sleep intervention" works to improve sleep and potentially reduce the risk of conditions like postpartum depression. The study is currently in Phase 1, where researchers are working with direct care workers to create and improve the intervention. To join Phase 1, you must be over 18 and work with expectant and new mothers in a community setting, meeting with clients at least four times during their pregnancy or after birth. The study will measure how many people are reached, how effective the intervention is, and how well it's accepted by participants.

Study design
This is an interventional study with a planned enrollment of 55 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures effectiveness and acceptability one month after training.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06737055

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

Recruiting
NAAges 18–99InterventionalHealth services
Rhode Island Hospital
~55 participants
Updated 2024-12-27 on ClinicalTrials.gov
What's tested:Education about behavioral strategies to improve sleep

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Reach
Measured over Throughout training period, i.e., for about 6 months; one time measure.
+6 more outcomes measured

Conditions

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

Explore related trials

InsomniaPostpartum DepressionPregnancy RelatedSleep Disorder

Where it's being run

1 sites across 1 states
Rhode Island1

Study leadership

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

Who to contact

Katherine M Sharkey, MD, PhD
[email protected]
401-793-3497
Email the study team

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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).

What this trial measures

  • Phase 1 ReachThroughout training period, i.e., for about 6 months; one time measure.

    Reach: Number of eligible workers who enroll in the training and number of workers who complete the training

  • Phase 1 EffectivenessAt enrollment and 1 month after training.

    Effectiveness: Participants are tested before and after training on sleep and circadian rhythm knowledge. Questions are based on the learning objectives for the educational modules. A successful outcome will be defined as \>= 70% of sleep knowledge questions answered correctly.

  • Phase 1 Acceptability1 month after training

    Acceptability: Participants will complete an online questionnaire to assess their perceptions of the training videos including Likert scales where they will report on (a) how prepared they feel to deliver the intervention; (b) ease of use; (c) compatibility with other resources they provide; and (d) the likelihood that they will use the app with their clients. This questionnaire will also include a short answer section for participants to report facilitators and barriers to use of the intervention.

  • Phase 2 Reachone time measure during enrollment period, ~ 6 months

    Reach: Investigators will track what percent of clients who are referred actually enroll, the number of pregnant vs. postpartum women who enroll, and the number of fathers/partners who enroll.

  • Phase 2 Effectiveness6 weeks after enrollment

    Effectiveness: Clients will complete a brief survey to assess their perceptions of the acceptability and utility of the intervention.

  • Phase 2 Effectiveness - Insomnia Severity Indexat enrollment and 6 weeks after enrollment

    Participants will complete the 7-item Insomnia Severity Index (ISI, range 0-28, higher scores indicate more sleep disturbance) at enrollment and 6 weeks after enrollment.

  • Phase 2 Effectiveness - Implementationfrom enrolllment through 6 weeks after enrollment

    Implementation: After clients enroll, investigators will assess quantitative implementation measures related to whether clients engage with the intervention as intended through metadata provided by the app and website (i.e., time spent on the app in minutes and time spent viewing videos in minutes).