Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 16, 2021
Open Peer Review Period: Jun 16, 2021 - Jun 22, 2021
Date Accepted: Jun 24, 2021
(closed for review but you can still tweet)
Optimizing Social-Emotional-Communication Development in Infants of Mothers with Depression: A Randomized Controlled Trial Protocol of a Mobile Intervention Targeting Depression and Responsive Parenting
ABSTRACT
Background:
Postpartum depression interferes with maternal engagement in interventions shown to be effective in improving infant social-emotional and communication outcomes. There is an absence of integrated interventions with demonstrated effectiveness in both reducing maternal depression and promoting parent-mediated practices that optimize infant social-emotional and communication competencies. Interventions targeting maternal depression are often separate from parent-mediated interventions. To address the life course needs of depressed mothers and their infants, we need brief, accessible, and integrated interventions that target both maternal depression and specific parent practices shown to improve infant social-emotional and communication trajectories.
Objective:
Evaluate the efficacy of a mobile internet intervention, Mom and Baby Net (MBN), with remote coaching to improve maternal mood and promote parent practices that optimize infant social-emotional and communication development.
Methods:
This is a 2-arm, randomized controlled, intent-to-treat trial. Primary outcomes include maternal depression symptoms and observed parent and infant behavior. Outcomes are measured via direct observational assessment and standardized questionnaires. The sample is being recruited within the urban core of a large southern city in the U.S. Study enrollment was initiated in 2017 and concluded in 2020. Participants are biological mothers with elevated depression symptoms, 18 years of age or older, who have custody of an infant less than 12 months of age. Exclusion criteria at the time of screening include maternal homelessness or shelter residence, inpatient mental health and/or substance abuse treatment, or maternal or infant treatment of a major mental or physical illness that would hinder meaningful study participation.
Results:
The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is underway. 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 African American and socioeconomically disadvantaged.
Conclusions:
Data collection is scheduled to conclude in March 2022. We anticipate that relative to the attention control condition, which is focused on education around maternal depression and infant developmental milestones with matching technology and coaching structure, mothers in the MBN intervention will experience greater reductions in depression and gains in sensitive and responsive parent practices, and that their infants will demonstrate greater gains in social-emotional and communication behavior. Clinical Trial: Clinicaltrials.gov, identifier NCT03464630, https://clinicaltrials.gov/ct2/show/NCT03464630
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