RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

RI