Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depression
  • Perinatal Depression
  • Postpartum Depression
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 child's infancy and early childhood. Previous postpartum depress...

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.

Tracking Information

NCT #
NCT03427528
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Darius Tandon, PhD Northwestern University