PMID- 34406122 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230920 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 10 IP - 8 DP - 2021 Aug 18 TI - 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. PG - e31072 LID - 10.2196/31072 [doi] LID - e31072 AB - BACKGROUND: Postpartum depression interferes with maternal engagement in interventions that are effective in improving infant social-emotional and social-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 social-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 social-communication trajectories. OBJECTIVE: The aim of this study is to evaluate the efficacy of a mobile internet intervention, Mom and Baby Net, with remote coaching to improve maternal mood and promote parent practices that optimize infant social-emotional and social-communication development. METHODS: This is a two-arm, randomized controlled intent-to-treat trial. Primary outcomes include maternal depression symptoms and observed parent and infant behaviors. Outcomes are measured via direct observational assessments and standardized questionnaires. The sample is being recruited from the urban core of a large southern city in the United States. Study enrollment was initiated in 2017 and concluded in 2020. Participants are biological mothers with elevated depression symptoms, aged 18 years or older, and 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 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 (RCT) was September 1, 2016. Data collection is ongoing. Following the institutional review board (IRB)-approved pilot work, the RCT was approved by the IRB on November 17, 2017. Recruitment was initiated immediately following IRB approval. Between February 15, 2018, and March 11, 2021, we successfully recruited a sample of 184 women and their infants into the RCT. The sample is predominantly African American and socioeconomically disadvantaged. CONCLUSIONS: Data collection is scheduled to be concluded 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 Mom and Baby Net 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 social-communication behavior. TRIAL REGISTRATION: ClinicalTrials.gov NCT03464630; https://clinicaltrials.gov/ct2/show/NCT03464630. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31072. CI - (c)Kathleen M Baggett, Betsy Davis, Lisa Sheeber, Katy Miller, Craig Leve, Elizabeth A Mosley, Susan H Landry, Edward G Feil. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.08.2021. FAU - Baggett, Kathleen M AU - Baggett KM AUID- ORCID: 0000-0002-3696-128X AD - Georgia State University, Atlanta, GA, United States. FAU - Davis, Betsy AU - Davis B AUID- ORCID: 0000-0003-3037-6546 AD - Oregon Research Institute, Eugene, OR, United States. FAU - Sheeber, Lisa AU - Sheeber L AUID- ORCID: 0000-0003-1293-943X AD - Oregon Research Institute, Eugene, OR, United States. FAU - Miller, Katy AU - Miller K AUID- ORCID: 0000-0002-7358-9130 AD - Georgia State University, Atlanta, GA, United States. FAU - Leve, Craig AU - Leve C AUID- ORCID: 0000-0003-1320-6115 AD - Oregon Research Institute, Eugene, OR, United States. FAU - Mosley, Elizabeth A AU - Mosley EA AUID- ORCID: 0000-0001-9534-2457 AD - Georgia State University, Atlanta, GA, United States. FAU - Landry, Susan H AU - Landry SH AUID- ORCID: 0000-0002-7820-3559 AD - University of Texas Health Sciences Center, Houston, TX, United States. FAU - Feil, Edward G AU - Feil EG AUID- ORCID: 0000-0002-1004-8900 AD - Oregon Research Institute, Eugene, OR, United States. LA - eng SI - ClinicalTrials.gov/NCT03464630 GR - R01 HD086894/HD/NICHD NIH HHS/United States PT - Journal Article DEP - 20210818 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC8411326 OTO - NOTNLM OT - infant social-emotional and social-communication development OT - maternal depression OT - mobile intervention OT - mobile phone OT - parenting OT - remote coaching OT - trial protocol COIS- Conflicts of Interest: KMB, BD, SHL, and EGF are the developers of the InfantNet program, and LS is the developer of the MBN program. Each of these programs contributed to the platform for the development of the ePALS MBN program, which was developed by KMB, BD, LS, and EGF. EDAT- 2021/08/19 06:00 MHDA- 2021/08/19 06:01 PMCR- 2021/08/18 CRDT- 2021/08/18 12:21 PHST- 2021/06/16 00:00 [received] PHST- 2021/06/24 00:00 [accepted] PHST- 2021/06/23 00:00 [revised] PHST- 2021/08/18 12:21 [entrez] PHST- 2021/08/19 06:00 [pubmed] PHST- 2021/08/19 06:01 [medline] PHST- 2021/08/18 00:00 [pmc-release] AID - v10i8e31072 [pii] AID - 10.2196/31072 [doi] PST - epublish SO - JMIR Res Protoc. 2021 Aug 18;10(8):e31072. doi: 10.2196/31072.