Skip to main content
Clinical Trials/NCT03427528
NCT03427528
Completed
Not Applicable

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

Northwestern University1 site in 1 country60 target enrollmentFebruary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perinatal Depression
Sponsor
Northwestern University
Enrollment
60
Locations
1
Primary Endpoint
Change in Depressive Symptoms
Status
Completed
Last Updated
3 years ago

Overview

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 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.

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 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.

Registry
clinicaltrials.gov
Start Date
February 15, 2018
End Date
September 4, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Darius Tandon

Associate Professor

Northwestern University

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Depressive Symptoms

Time Frame: Baseline and Post Intervention at 3 and 6 months

Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63. 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.

Change in Perceived Stress

Time Frame: Baseline and Post Intervention at 3 and 6 months

Perceived Stress Scale 10-item Scale (PSS-10) (Cohen \& Williamson, 1988). The PSS-10 is a 10-item survey that asks respondents to indicate on a 5-point scale the extent to which they appraised certain situations as stressful over the past month, with higher scores indicating greater perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. 0-13 are considered low stress Scores ranging from 14-26 are considered moderate stress Scores ranging from 27-40 are considered high perceived stress

Change in Anxiety

Time Frame: Baseline and Post Intervention at 3 and 6 months

Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer et al., 2006). The GAD-7 is a 7-item survey, each item asks respondents to indicate on a 4-point scale the extent to which they endorse different symptoms of anxiety over the past two weeks with higher scores indicating greater anxiety symptoms. The highest score is 21. Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety

Secondary Outcomes

  • Instrumental Social Support Support Survey (Cyranowski et al., 2013).(Baseline and Post Intervention at 3 and 6 months)
  • Change in Social Support Effectiveness(Baseline and Post Intervention at 3 and 6 months)
  • Emotional Support Support (Cyranowski et al., 2013)(Baseline and Post Intervention at 3 and 6 months)

Study Sites (1)

Loading locations...

Similar Trials