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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2022-07-01

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

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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 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.

Conditions

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Maternal Depression and Parent Practices, Postpartum Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm, randomized controlled intent to treat trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Assessment coders and participants are naive to treatment condition

Study Groups

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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

Group Type EXPERIMENTAL

Mom & Baby Net

Intervention Type 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

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)

Group Type ACTIVE_COMPARATOR

Depression & Developmental Awareness System

Intervention Type 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)

Interventions

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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

Intervention Type 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)

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes