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      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


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          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.


          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.


          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.


          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.


          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)


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          The Patient Health Questionnaire-2: validity of a two-item depression screener.

          A number of self-administered questionnaires are available for assessing depression severity, including the 9-item Patient Health Questionnaire depression module (PHQ-9). Because even briefer measures might be desirable for use in busy clinical settings or as part of comprehensive health questionnaires, we evaluated a 2-item version of the PHQ depression module, the PHQ-2. The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). The PHQ-2 was completed by 6000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-2 depression severity increased from 0 to 6, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-2 score > or =3 had a sensitivity of 83% and a specificity of 92% for major depression. Likelihood ratio and receiver operator characteristic analysis identified a PHQ-2 score of 3 as the optimal cutpoint for screening purposes. Results were similar in the primary care and obstetrics-gynecology samples. The construct and criterion validity of the PHQ-2 make it an attractive measure for depression screening.
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                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2021
                18 August 2021
                : 10
                : 8
                : e31072
                [1 ] Georgia State University Atlanta, GA United States
                [2 ] Oregon Research Institute Eugene, OR United States
                [3 ] University of Texas Health Sciences Center Houston, TX United States
                Author notes
                Corresponding Author: Kathleen M Baggett kbaggett@ 123456gsu.edu
                Author information
                ©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.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 16 June 2021
                : 22 June 2021
                : 23 June 2021
                : 24 June 2021
                Custom metadata
                This paper was peer reviewed by the Center for Scientific Review Special Emphasis Panel - Member Conflict: Developmental Risk Prevention, Aging and Social Behavior (National Institutes of Health). See the Multimedia Appendix for the peer-review report;

                maternal depression,parenting,infant social-emotional and social-communication development,mobile intervention,remote coaching,trial protocol,mobile phone


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