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

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Georgia State University

Status

Completed

Conditions

Maternal Depression and Parent Practices, Postpartum
Infant Development

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03464630
R01HD086894-01A1 (U.S. NIH Grant/Contract)
1R01HD086894

Details and patient eligibility

About

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

Full 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.

Enrollment

368 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

368 participants in 2 patient groups

Mom & Baby Net
Experimental group
Description:
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
Treatment:
Behavioral: Mom & Baby Net
Depression & Developmental Awareness System
Active Comparator group
Description:
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)
Treatment:
Behavioral: Depression & Developmental Awareness System

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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