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

Not Applicable

Completed

Conditions: Infant Development
Maternal Depression and Parent Practices, Postpartum

Interventions: Behavioral: Mom & Baby Net
Behavioral: Depression & Developmental Awareness System

Registration Number: NCT03464630

Lead Sponsor: Georgia State University

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

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 368

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mom & Baby Net	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
Depression & Developmental Awareness System	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)

Primary Outcome Measures

Name	Time	Method
Landry Parent Child Interaction Rating Scales - Mother Negative Behavior	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)
Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend	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);
Indicator of Parent Child Interaction (IPCI) - Child Positive Social	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);
Landry Parent Child Interaction Rating Scales - Mother Positive Behavior	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);
PHQ9	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
Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior	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)
Indicator of Parent Child Interaction (IPCI) - Child Engagement	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)
Knowledge of Infant Social-Emotional Development and Promotion	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
Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive	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)