Skip to main content
OpenTrials
Completed

NCT Number: NCT03464630

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

A mobile remote coaching program study to improve maternal mood and increase parenting practices that lead to better infant social-emotional and communication outcomes

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maternal Depression and Parent Practices, Postpartum Infant Development

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30302, United States

About this study

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 a total sample of 368 participants (184 mothers with depression and 184 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 total sample of 368 participants (184 women and 184 infants) into the randomized controlled trial. The sample is predominantly Black and socioeconomically disadvantaged.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mom & Baby Net

Behavioral

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

Depression & Developmental Awareness System

Behavioral

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)

Primary outcomes

  1. PHQ9

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome

  2. Landry Parent Child Interaction Rating Scales - Mother Positive Behavior

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

    mother positive behavior (values = 4-20; higher scores = better outcomes);

  3. Landry Parent Child Interaction Rating Scales - Mother Negative Behavior

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Dichotomized rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

    mother negative behavior (values = 0-1; higher scores = worse outcomes)

  4. Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Rating scale used for coding observed parent and child behavior during semi-structured free play. Reported outcomes include:

    child positive/engagement behavior (values = 2-10; higher scores = better outcomes)

  5. Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

    Mother Maintain/Extend (values = 0-100%; higher = better outcomes);

  6. Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

    Mother Overall Positive (values = 0-100%; higher = better outcomes)

  7. Indicator of Parent Child Interaction (IPCI) - Child Positive Social

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

    Child Positive Social (values = 0-100%; higher = better outcomes);

  8. Indicator of Parent Child Interaction (IPCI) - Child Engagement

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes:

    Child Engagement (values = 0-100%; higher = better outcomes)

  9. Knowledge of Infant Social-Emotional Development and Promotion

    Time frame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

    Rating scale used to assess understanding of the concepts of infant social-emotional behavior and its promotion by caregivers, assessing both definitional and applied concept knowledge; values = 0-28 higher scores = better outcomes

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

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

Registry information

Acronym: MBN

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2018
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.