Clinical trial NCT03464630: Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
Official title: Reducing Maternal Depression and Promoting Infant Social-Emotional Health & Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Oregon Research Institute
name: The University of Texas Health Science Center, Houston
First posted: 2018-03-14
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, randomized controlled intent to treat trial
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: PHQ9
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Landry Parent Child Interaction Rating Scales - Mother Positive Behavior
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Landry Parent Child Interaction Rating Scales - Mother Negative Behavior
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Landry Parent Child Interaction Rating Scales - Child Positive/Engagement Behavior
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Indicator of Parent Child Interaction (IPCI) - Mother Maintain/Extend
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Indicator of Parent Child Interaction (IPCI) - Mother Overall Positive
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Indicator of Parent Child Interaction (IPCI) - Child Positive Social
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Indicator of Parent Child Interaction (IPCI) - Child Engagement
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
measure: Knowledge of Infant Social-Emotional Development and Promotion
timeFrame: Pre-intervention at Baseline (T1 data collected); [Intervention Period (8 months)]; Post-intervention (T2 data collected; 1 month post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Kathleen Baggett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.