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

NCT03464630 | Completed Results

• 2 other identifiers: 1R01HD086894R01HD086894-01A1
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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

Conditions

Maternal Depression and Parent Practices, Postpartum; Infant Development

Keywords

Treatment Maternal depression postpartum; Optimizing Maternal parenting practices; Optimizing Infant development; Optimizing Infant behavior; Direct observation of mother-Infant interaction; M health intervention; Remote coaching; RCT

Outcome Measures

Primary Outcomes (9)

• PHQ9

  Depression symptoms; Patient Health Questionnaire-9; values = 0-27; higher scores = worse outcome

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Landry Parent Child Interaction Rating Scales - Mother Positive Behavior

  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);

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Landry Parent Child Interaction Rating Scales - Mother Negative Behavior

  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)

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior

  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)

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend

  Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Maintain/Extend (values = 0-100%; higher = better outcomes);

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive

  Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Mother Overall Positive (values = 0-100%; higher = better outcomes)

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Indicator of Parent Child Interaction (IPCI) - Child Positive Social

  Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Positive Social (values = 0-100%; higher = better outcomes);

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Indicator of Parent Child Interaction (IPCI) - Child Engagement

  Direct observation, semi-structured direct infant-mother interaction looking at books. Reported includes: Child Engagement (values = 0-100%; higher = better outcomes)

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

• Knowledge of Infant Social-Emotional Development and Promotion

  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

  Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)

Study Arms (2)

Mom & Baby Net

EXPERIMENTAL

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

Depression & Developmental Awareness System

ACTIVE COMPARATOR

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

Interventions

Mom & Baby Net 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

Mom & Baby Net

Depression & Developmental Awareness System 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)

Depression & Developmental Awareness System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Georgia State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Oregon Research Institute: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

Related Publications (3)

• 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.

  PMID: 34456828 BACKGROUND

• 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.

  PMID: 33276610 BACKGROUND

• 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.

  PMID: 34406122 BACKGROUND

Results Point of Contact

• Title: Dr. Kathleen Baggett
• Organization: Georgia State University

kbaggett@gsu.edu

404-413-1571

Study Officials

• Kathleen Baggett, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessment coders and participants are naive to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two arm, randomized controlled intent to treat trial

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 14, 2018
• Study Start: February 15, 2018
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)