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NCT Number: NCT06737055

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

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.

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Key information

Conditions

Sleep Behavior Depression, Postpartum Depressive Disorder Dyssomnias Female Urogenital Diseases and Pregnancy Complications Health Behavior Insomnia Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Postpartum Depression Pregnancy Complications Pregnancy Related Puerperal Disorders Signs and Symptoms Sleep Deprivation Sleep Disorders, Intrinsic Sleep Disturbance Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Katherine M Sharkey, MD, PhD

CONTACT

[email protected]

401-793-3497

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dream Team Training

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine M Sharkey, MD, PhD

CONTACT

[email protected]

401-793-3497

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Bradley Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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