Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03427528
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2018-01-29
Brief Title:
Development Feasibility and Acceptability of Fathers and Babies FAB A Pilot Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 partners 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
Detailed Description:
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 childs 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 childrens 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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21MD011320-01 | NIH | None | httpsreporternihgovquickSearch1R21MD011320-01 |