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NCT03420755 · ClinicalTrials.gov registry record · NA
Integrating Text Messages Into the Mothers and Babies Course
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT03420755 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 63 participants.
The verdict
NCT03420755, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
This project is aimed at enhancing the effectiveness and scalability of the Mothers and Babies 1-on-1 Course (MB) among home visiting programs. MB is a manualized 12-session postpartum depression prevention intervention guided by cognitive-behavioral therapy and attachment theory. Each session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit. Previous MB trials suggest that the intervention is less successful for women who exhibit smaller changes in hypothesized intervention mechanisms and less fully engaged in completion of personal projects. This study will determine the feasibility and acceptability of conducting MB-TXT, in which home visiting clients receive MB supplemented by a series of weekly text messages focused on skill reinforcement, personal project reminders, and self-monitoring of depressive symptoms. The investigators will also calculate a preliminary effect size that could be used to calculate sample size necessary for a future fully powered randomized controlled trial that examines MB-TXT efficacy. The investigators will use a stepped wedge design-a form of randomized controlled trial that involves sequential, but random, roll-out of the intervention over multiple time periods. The investigators have created two HV program clusters. Both clusters will initially implement MB 1-on-1 and will recruit MB participants for one quarter (i.e., three months) before crossing over to recruit MB-TXT participants for one quarter. MB-TXT's core curriculum is identical to MB 1-on-1 and adds a series of text messages throughout the curriculum. Feasibility and acceptability data will be collected from clients and home visitors to assess percentages of received text messages, home visitor adherence to sending texts at specified intervals, and clients' perceptions of text message utility and clarity. If the investigators are able to integrate MB-TXT and home visiting programs and generate improved mental health outcomes for clients, the
Interventions
- BEHAVIORAL Mothers and Babies 1-on-1
- BEHAVIORAL Mothers and Babies Plus Text
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03420755
The ClinicalTrials.gov registry entry for NCT03420755 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mothers and Babies 1-on-1 is the first listed.
NCT03420755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03420755 about?
NCT03420755 is a clinical study titled "Integrating Text Messages Into the Mothers and Babies Course". This project is aimed at enhancing the effectiveness and scalability of the Mothers and Babies 1-on-1 Course (MB) among home visiting programs. MB is a manualized 12-session postpartum depression prevention intervention guided by cognitive-behavioral therapy and attachment theory. Each session lasts...
What is the current status of trial NCT03420755?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2017-06-07. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03420755?
The interventions under investigation include: Mothers and Babies 1-on-1 (BEHAVIORAL), Mothers and Babies Plus Text (BEHAVIORAL).
Who is sponsoring clinical trial NCT03420755?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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