Clinical trial NCT06737055: The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
Official title: The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Postpartum Depression
Pregnancy Related
Insomnia
Sleep Deprivation
Sleep Hygiene
Sleep Disturbance
Keywords: Home visitors
sleep diaries
education
implementation
RE-AIM
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Bradley Hospital
First posted: 2024-12-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an implementation science project to develop and test an educational program for teaching home visitors and expectant and new parents about sleep. The study uses the RE-AIM framework.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).

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 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.

Primary outcomes:
measure: Phase 1 Reach
timeFrame: Throughout training period, i.e., for about 6 months; one time measure.
measure: Phase 1 Effectiveness
timeFrame: At enrollment and 1 month after training.
measure: Phase 1 Acceptability
timeFrame: 1 month after training
measure: Phase 2 Reach
timeFrame: one time measure during enrollment period, ~ 6 months
measure: Phase 2 Effectiveness
timeFrame: 6 weeks after enrollment
measure: Phase 2 Effectiveness - Insomnia Severity Index
timeFrame: at enrollment and 6 weeks after enrollment
measure: Phase 2 Effectiveness - Implementation
timeFrame: from enrolllment through 6 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Katherine M Sharkey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: