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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mom & Baby Net
Depression & Developmental Awareness System
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression and Parent Practices, Postpartum focused on measuring 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, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Georgia State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mom & Baby Net

Depression & Developmental Awareness System

Arm 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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2018
Last Updated
July 11, 2022
Sponsor
Georgia State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Oregon Research Institute, The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03464630
Brief Title
Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
Acronym
MBN
Official Title
Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Oregon Research Institute, The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression and Parent Practices, Postpartum, Infant Social-Emotional and Social Communication Competency Development
Keywords
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, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arm, randomized controlled intent to treat trial
Masking
ParticipantOutcomes Assessor
Masking Description
Assessment coders and participants are naive to treatment condition
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mom & Baby Net
Arm Type
Experimental
Arm 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
Arm Title
Depression & Developmental Awareness System
Arm Type
Active Comparator
Arm 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)
Intervention Type
Behavioral
Intervention Name(s)
Mom & Baby Net
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Depression & Developmental Awareness System
Intervention 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)
Primary Outcome Measure Information:
Title
PHQ9
Description
Depression symptoms and severity
Time Frame
Pre, Post, and Follow-Up
Title
Landry Parent Child Interaction Rating Scales
Description
Rating scale used for coding observed parent and child behavior during semi-structured free play.
Time Frame
Pre and Post
Title
Indicator of Parent Child Interaction (IPCI)
Description
Direct observation, semi-structured direct infant-mother interaction looking at books
Time Frame
Pre and Post

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Baggett, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34456828
Citation
Baggett KM, Davis B, Mosley EA, Miller K, Leve C, Feil EG. Depressed and Socioeconomically Disadvantaged Mothers' Progression Into a Randomized Controlled Mobile Mental Health and Parenting Intervention: A Descriptive Examination Prior to and During COVID-19. Front Psychol. 2021 Aug 12;12:719149. doi: 10.3389/fpsyg.2021.719149. eCollection 2021.
Results Reference
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PubMed Identifier
33276610
Citation
Baggett KM, Davis B, Sheeber LB, Ammerman RT, Mosley EA, Miller K, Feil EG. Minding the Gatekeepers: Referral and Recruitment of Postpartum Mothers with Depression into a Randomized Controlled Trial of a Mobile Internet Parenting Intervention to Improve Mood and Optimize Infant Social Communication Outcomes. Int J Environ Res Public Health. 2020 Dec 2;17(23):8978. doi: 10.3390/ijerph17238978.
Results Reference
background
PubMed Identifier
34406122
Citation
Baggett KM, Davis B, Sheeber L, Miller K, Leve C, Mosley EA, Landry SH, Feil EG. Optimizing Social-Emotional-Communication Development in Infants of Mothers With Depression: Protocol for a Randomized Controlled Trial of a Mobile Intervention Targeting Depression and Responsive Parenting. JMIR Res Protoc. 2021 Aug 18;10(8):e31072. doi: 10.2196/31072.
Results Reference
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Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development

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