Recruiting

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

Sponsor:

Rhode Island Hospital

Code:

NCT06737055

Conditions

Sleep

Postpartum Depression

Pregnancy Related

Insomnia

Sleep Deprivation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Education about behavioral strategies to improve sleep

Study Details

Brief summary:

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.

Conditions

Sleep

Postpartum Depression

Pregnancy Related

Insomnia

Sleep Deprivation

Study ID

NCT06737055

Start date

Aug 8, 2023

Status verified date

Dec, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Home Visitors

The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity.

experimental: Expectant and New Parents

Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep.

To qualify for enrollment, Phase 2 participants must be:

expectant parents OR new parents up to 1 year postpartum
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 sleep diaries and assessments
are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver

Interventions

Education about behavioral strategies to improve sleep

In collaboration with direct care workers, the investigators are developing an intervention to help home visitors support clients who experience sleep difficulties in the perinatal period. The intervention consists of a series of educational videos about promoting healthy sleep and addressing sleep difficulties during pregnancy and the postpartum period.

Primary outcome measure

Phase 1 Reach [ Time Frame: Throughout training period, i.e., for about 6 months; one time measure. ]
Phase 1 Effectiveness [ Time Frame: At enrollment and 1 month after training. ]
Phase 1 Acceptability [ Time Frame: 1 month after training ]
Phase 2 Reach [ Time Frame: one time measure during enrollment period, ~ 6 months ]
Phase 2 Effectiveness [ Time Frame: 6 weeks after enrollment ]
Phase 2 Effectiveness - Insomnia Severity Index [ Time Frame: at enrollment and 6 weeks after enrollment ]
Phase 2 Effectiveness - Implementation [ Time Frame: from enrolllment through 6 weeks after enrollment ]

Central Contacts and Locations

Central contacts

Katherine M Sharkey, MD, PhD

401-793-3497 katherine_sharkey@brown.edu

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Katherine M Sharkey, MD, PhD

401-793-3497 katherine_sharkey@brown.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Dec 27, 2024

Last verified

Dec, 2024

Keywords

Home visitors
sleep diaries
education
implementation
RE-AIM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2024-12-27.