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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorRhode Island Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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).

expectant parents OR new parents up to 1 year postpartum;

age 18 to 45 years old;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Home VisitorsExperimental treatment 1 intervention
Group B: Expectant and New ParentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 Reach

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

Time frame
Throughout training period, i.e., for about 6 months; one time measure.
2

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.

Time frame
At enrollment and 1 month after training.
3

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.

Time frame
1 month after training
4

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.

Time frame
one time measure during enrollment period, ~ 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Rhode Island Hospital

Lead sponsor

Bradley Hospital

Collaborator