CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Fathers and Babies (FAB) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03427528
NCT03427528N/ACompleted

Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners

Northwestern University·interventional·Posted Feb 9, 2018·Updated Jul 18, 2022

In Brief

A clinical study evaluating Fathers and Babies (FAB) and MB 1-on-1 plus TXT for Perinatal Depression and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for home visiting clients. Focus groups with prior study participants, their male partners, and home visiting staff will be used to develop the FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male partner and help him support his partner's mental health. Feasibility, acceptability, and outcome measures will be supplemented with assessments of fathers' mental health and partners' relationships. Participant assessments will be conducted at baseline, 3 and 6 months in this uncontrolled pilot study. The public health significance and innovation of this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD into home visiting programs and generate improved mental health outcomes for home visiting clients and their partners, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visitation as a service delivery model for families with infants and young children is rapidly proliferating through federal funding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartFeb 15, 2018
Primary CompletionSep 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.4 years ago

Interventions

Fathers and Babies (FAB)behavioral

The initial FAB session was delivered in person or by phone by the home visitor working with the mother, and lasted 30 min on average. Subsequent sessions were delivered, in-person, via text message with embedded links to online content, or a mix of both in-person and text messages, depending on the preference and availability of the father. Fathers received three to six text messages per FAB session.

MB 1-on-1 plus TXTbehavioral

Home visiting clients received the Mothers and Babies with -Text Messages intervention in person during regular scheduled home visits (i.e., MB 1-on-1 plus MB-TXT). After each in person session home visiting clients receive three messages to reinforce skill practice and remind them about their personal projects.