Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study
NCT ID: NCT03427528
Last Updated: 2022-07-18
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-15
Study Completion Date
2020-09-04
Brief Summary
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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.
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Detailed Description
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Enhancements to Mothers and Babies are warranted to address the mental health of both parents, via the home visitation service delivery model where many of the most at-risk families enter into provider-client relationships during their child's infancy and early childhood.
Previous postpartum depression preventive interventions-including MB-have neglected to intervene with partners of pregnant women, despite the growing recognition that paternal depression also exerts influence on children's social-emotional development and occurs in a similar time-frame. Thus, in an otherwise successful intervention, these limitations-mixed success in improving hypothesized intervention mechanisms and limited engagement of fathers-may mitigate intervention efficacy. Paternal depression is hypothesized to mediate the relationship between MB modules and maternal mental health outcomes.
This study addresses this limitation. The investigators will collaborate with 10-12 home visiting (HV) programs serving primarily low-income families. The investigators will recruit 24 mother-father dyads for an uncontrolled pilot in which mothers will receive MB-TXT and fathers will receive FAB, a pilot curriculum developed using existing materials and data collected via qualitative research with home visiting clients, their partners, and home visiting staff.
Aim 1. To develop and determine the feasibility and acceptability of a) conducting the MB-DAD intervention protocol and b) assessing paternal and dyadic outcomes across two home visiting programs. Focus groups with prior trial participants, their male partners, and home visiting staff will generate information on a) intervention content, b) frequency of contact, and c) relationship to MB materials received by their partner.
Previous postpartum depression preventive interventions-including MB-have neglected to intervene with partners of pregnant women, despite the growing recognition that paternal depression also exerts influence on children's social-emotional development and occurs in a similar time-frame. Thus, in an otherwise successful intervention, these limitations-mixed success in improving hypothesized intervention mechanisms and limited engagement of fathers-may mitigate intervention efficacy. Paternal depression is hypothesized to mediate the relationship between MB modules and maternal mental health outcomes.
This study addresses this limitation. The investigators will collaborate with 10-12 home visiting (HV) programs serving primarily low-income families. The investigators will recruit 24 mother-father dyads for an uncontrolled pilot in which mothers will receive MB-TXT and fathers will receive FAB, a pilot curriculum developed using existing materials and data collected via qualitative research with home visiting clients, their partners, and home visiting staff.
Aim 1. To develop and determine the feasibility and acceptability of a) conducting the MB-DAD intervention protocol and b) assessing paternal and dyadic outcomes across two home visiting programs. Focus groups with prior trial participants, their male partners, and home visiting staff will generate information on a) intervention content, b) frequency of contact, and c) relationship to MB materials received by their partner.
Conditions
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Postpartum Depression
Depression
Perinatal Depression
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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FAB Pilot Study (Father/Male Participants)
Fathers (male partners) received Fathers and Babies (FAB). FAB is a 12-session intervention with content that mirrors content found in MB, but was father-centric.
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.
Group Type
EXPERIMENTAL
Fathers and Babies (FAB)
Intervention Type
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 TEXT (Mother/Female Participants)
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) while her partner received Fathers and Babies in parallel. MB 1-on-1 is 12-sessions and is a postpartum depression preventive intervention. MB includes an introductory module followed by three cognitive-behavioral therapy modules: (1) pleasant activities, (2) thoughts, and (3) contact with others. After each in person session home visiting clients receive three messages to reinforce skill practice and remind them about their personal projects.
Group Type
EXPERIMENTAL
MB 1-on-1 plus TXT
Intervention Type
BEHAVIORAL
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.
Interventions
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Fathers and Babies (FAB)
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.
Intervention Type
BEHAVIORAL
MB 1-on-1 plus TXT
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
English-speaking women \>18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Male partners of English-speaking women \>18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Note: Both parents/partners are required to participate in this study, not just one or the other.
Male partners of English-speaking women \>18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Note: Both parents/partners are required to participate in this study, not just one or the other.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
lead
Responsible Party
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Darius Tandon
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Darius Tandon, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU00203918-B
Identifier Type: -
Identifier Source: org_study_id
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