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

NCT06737055 | Recruiting

• 1 other identifier: 1848819
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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; Sleep Hygiene; Sleep Disturbance

Keywords

Home visitors; sleep diaries; education; implementation; RE-AIM

Outcome Measures

Primary Outcomes (7)

• Phase 1 Reach

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

  Throughout training period, i.e., for about 6 months; one time measure.

• Phase 1 Effectiveness

  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.

  At enrollment and 1 month after training.

• Phase 1 Acceptability

  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.

  1 month after training

• Phase 2 Reach

  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.

  one time measure during enrollment period, ~ 6 months

• Phase 2 Effectiveness

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

  6 weeks after enrollment

• Phase 2 Effectiveness - Insomnia Severity Index

  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.

  at enrollment and 6 weeks after enrollment

• Phase 2 Effectiveness - Implementation

  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).

  from enrolllment through 6 weeks after enrollment

Study Arms (2)

Home Visitors

EXPERIMENTAL

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.

Behavioral: Education about behavioral strategies to improve sleep

Expectant and New Parents

EXPERIMENTAL

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

Behavioral: Education about behavioral strategies to improve sleep

Interventions

Education about behavioral strategies to improve sleep BEHAVIORAL

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.

Also known as: Dream Team Training

Expectant and New Parents; Home Visitors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• The investigators will exclude potential participants whose infants will not be living in the home or who will have a nighttime caregiver.

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Bradley Hospital: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Sleep Hygiene; Parasomnias

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Katherine M Sharkey, MD, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine M Sharkey, MD, PhD

CONTACT

401-793-3497; katherine_sharkey@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: December 17, 2024
• Study Start: August 8, 2023
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The informed consent documents will be posted on a federal website after enrollment closes and no later than 60 days after the last study visit of any participant. English language consent forms will be posted at ClinicalTrials.gov and Non-English consent forms will be posted to Regulations.gov. Additionally, results will be reported no later than one year after the actual completion date listed in ClinicalTrials.gov.
• Access Criteria: By request to the PI.

Locations

US (1)