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

• ClinicalTrials.gov Identifier: NCT03464630
• Recruitment Status: Active, not recruiting
• First Posted: March 14, 2018
• Last Update Posted: February 1, 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
• Information provided by (Responsible Party): Kathleen Baggett, Georgia State University

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

Condition or disease	Intervention/treatment	Phase
Maternal Depression and Parent Practices, Postpartum; Infant Social-Emotional and Social Communication Competency Development	Behavioral: Mom & Baby Net; Behavioral: Developmental Awareness System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arm, randomized controlled intent to treat trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Assessment coders and participants are naive to treatment condition
• Primary Purpose: Treatment
• Official Title: Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
• Actual Study Start Date: February 15, 2018
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mom & Baby Net; CBT skills based M-health intervention targeting maternal depression and and sensitive responsive parenting practices for optimizing infant social-communication promotion	Behavioral: Mom & Baby Net; Skills based maternal depression treatment and targeted infant social-communication promotion
Active Comparator: Depression & Developmental Awareness System; Supportive, person-centered M-health intervention targeting maternal awareness of maternal depression symptoms, infant developmental milestones, and community resources (active control condition)	Behavioral: Developmental Awareness System; Depression and infant develop awareness

Outcome Measures

Primary Outcome Measures :

1. Landry Parent Child Interaction Rating Scales [ Time Frame: Change in parent and child scores from pre-assessment to post-assessment (8.5 months after pre-assessment) and from pre-assessment to the 1-month post follow up assessment, 3-month post follow up assessment , and 6-month post follow up assessment. ]
   Rating scale used for coding observed parent and child behavior. A total score is summed for parent behaviors and child behaviors, respectively, and can range from 7-35 for parent behaviors and 5-25 for child behaviors, with high scores representing positive behavior (better outcomes).
2. PHQ9 [ Time Frame: Change in maternal depression symptoms from pre-assessment to post-assessments (8.5 months after pre-assessment) and from pre-assessment to the 1-month post follow up assessment, 3-month post follow up assessment , and 6-month post follow up assessment. ]
   Depression screening

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Mom is 18 years of age
• Mom speaks English
• Mom lives in metro-Atlanta area
• Mom has baby younger than 12 months of age

Exclusion Criteria:

• stressors that may interfere with mother or infant 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

Contacts and Locations

Locations

United States, Georgia

Georgia State University

Atlanta, Georgia, United States, 30302

Sponsors and Collaborators

Georgia State University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oregon Research Institute

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Kathleen Baggett, PhD; Georgia State University

  Study Documents (Full-Text)

Documents provided by Kathleen Baggett, Georgia State University:

Informed Consent Form  [PDF] November 16, 2018

More Information

Additional Information:

Optimizing Social-Emotional and Social Communication Development in Infants of Mothers with Depression: Randomized Controlled Trial Protocol of a Mobile Intervention Targeting Depression and Responsive Parenting 

Publications:

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.

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). pii: E8978. doi: 10.3390/ijerph17238978.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kathleen Baggett, Associate Professor, Georgia State University
• ClinicalTrials.gov Identifier: NCT03464630
• Other Study ID Numbers: 1R01HD086894 ( U.S. NIH Grant/Contract ); R01HD086894-01A1 ( U.S. NIH Grant/Contract )
• First Posted: March 14, 2018
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Kathleen Baggett, Georgia State University:

Treatment Maternal depression postpartum; Optimizing Maternal parenting practices; Optimizing Infant social-emotional competency develoment; Optimizing Infant social communication competency development; Direct observation of mother-Infant interaction; M health intervention; Remote coaching; RCT

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders