NCT06737055 · Rhode Island Hospital
The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Phase 1 Reach
Time frame: Throughout 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 Effectiveness
Time frame: At 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 Acceptability
Time frame: 1 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 Reach
Time frame: one 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 Effectiveness
Time frame: 6 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 Index
Time frame: at 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 - Implementation
Time frame: from 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Providence, Rhode Island
Collaborators
Bradley Hospital
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 27, 2024 · Source of record for eligibility and locations