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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Depression and Parent Practices, Postpartum, Infant Social-Emotional and Social Communication Competency Development

Intervention / Treatment
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* Behavioral: Mom & Baby Net
* Behavioral: Depression & Developmental Awareness System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arm, randomized controlled intent to treat trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mom & Baby Net<br>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<br>* 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<br>|
| Active Comparator: Depression & Developmental Awareness System<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Treatment Maternal depression postpartum, Optimizing Maternal parenting practices, Optimizing Infant social-emotional competency development, Optimizing Infant social communication competency development, Direct observation of mother-Infant interaction, M health intervention, Remote coaching