NCT03464630

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Georgia State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Maternal Depression and Parent Practices, Postpartum
• Infant Development

Interventions

Type	Name	Description
BEHAVIORAL	Mom & Baby Net	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	Depression & Developmental Awareness System	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)

Timeline

• Start date: 2018-02-15
• Primary completion: 2022-06-01
• Completion: 2022-07-01
• First posted: 2018-03-14
• Last updated: 2024-06-20
• Results posted: 2024-06-20

Locations

1 site across 1 country: United States