Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development (MBN)

July 11, 2022 updated by: Kathleen Baggett, Georgia State University
A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To address the life course needs of depressed mothers and their infants, brief, accessible, and integrated interventions that target both maternal depression and specific nurturing parent behaviors demonstrated to improve infant social-emotional communication outcomes are needed. In prior programmatic research, two separate web-based, remote coaching interventions for: (a) parent nurturing behaviors that improve infant outcomes (Baby-Net R34; R01) [13], and (b) maternal depression (Mom-Net R34; R01) [14] were developed. Compared to controls, the Baby-Net program demonstrated medium to large effects on observed nurturing parent behavior and on infant social-emotional competencies in the context of play [13] and in the context of book activities [15]. Mom-Net demonstrated low attrition and high levels of feasibility, program use, and satisfaction [14]. Compared to controls, Mom-Net participants demonstrated significant reductions in depression and improved preschool parenting behavior [14]. A substantial advantage of the mobile, remote coaching approach is that it overcomes multiple logistical barriers that often prevent low-income mothers from participating in community/home visiting treatment programs [2]. Thus, this prior research on web-based maternal depression and specific nurturing parenting behavior in infancy, provides a strong empirical basis for the Mom & Baby Net program. Investigators will rigorously test the merged Mom & Baby Net intervention effects with 184 low-income mothers with depression and their infants via a 2-arm, intent-to-treat, randomized controlled trial.

The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is currently underway and scheduled to conclude in March 2022. Following IRB-approved pilot work, the randomized controlled trial was IRB- approved on November 17, 2017. Immediately following IRB approval, recruitment was initiated. Between February 15, 2018 and March 11, 2021, we successfully consented a sample of 184 women and their infants into the randomized controlled trial. The sample is predominantly Black and socioeconomically disadvantaged.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mother is 18 years of age
  • Mother speaks English
  • Mother lives in metro-Atlanta area
  • Mother has baby younger than 12 months of age
  • Mother has positive depression screen (PHQ2)

Exclusion Criteria:

Stressors that mother specifies at the time of screening that would interfere with study participation such as: maternal homelessness, mental or physical health condition (diagnosed with schizophrenia or treatment/medication for hallucinations/delusions), current inpatient treatment for mental health or substance abuse. Infant exclusion criteria include factors that could render research participation stressful, such as intensive treatment for a genetic or health condition or not in permanent legal guardian custody

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mom & Baby Net
CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral
Behavioral: Mom & Baby Net
CBT skills based mobile intervention targeting maternal depression and sensitive responsive parenting practices for optimizing infant social-communication promotion and provision of community resources and referral
Active Comparator: Depression & Developmental Awareness System
Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition)
Behavioral: Depression & Developmental Awareness System
Supportive, person-centered mobile intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and provision of community resources and referral (active control condition)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ9
Time Frame: Pre, Post, and Follow-Up
Depression symptoms and severity
Pre, Post, and Follow-Up
Landry Parent Child Interaction Rating Scales
Time Frame: Pre and Post
Rating scale used for coding observed parent and child behavior during semi-structured free play.
Pre and Post
Indicator of Parent Child Interaction (IPCI)
Time Frame: Pre and Post
Direct observation, semi-structured direct infant-mother interaction looking at books
Pre and Post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia State University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Oregon Research Institute

Investigators

  • Principal Investigator: Kathleen Baggett, PhD, Georgia State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HD086894 (U.S. NIH Grant/Contract)
  • R01HD086894-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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