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Summaries of RCT Grants

Randomized controlled trial of 123-MOMS to reduce maternal depression among new mothers and improve early childhood cognitive development

The program will be delivered using a telehealth approach via iPads provided to study participants.

Grant Recipient: Yale University

Principal Investigator:

Costas Meghir, Ph.D., Yale University

Orazio Attanasio, Ph.D, Yale University 

Linda Mayes, Ph.D., Yale University

Term: 2021 — 2025

Funding: $284,930

Summary: This project is an RCT of 123-MOMS — a manualized program that consists of three main components: (i) cognitive-behavioral therapy (CBT) for mothers in their second trimester of pregnancy; (ii) individual parenting training immediately postpartum for eight weeks; and (iii) parent-led infant stimulation for 12 months postpartum. The program will be delivered using a telehealth approach via iPads provided to study participants. 

A prior RCT of Mothers and Babies, a related intervention that provided CBT to pregnant mothers, found it substantially reduced depressive symptoms and depressive episodes at six months post-intervention, while three RCTs of telehealth adaptations of CBT found clinically significant, albeit also short-term, reductions in depressive symptoms. In general, while prior studies of interventions similar to 123-MOMS provide encouraging signals of meaningful effects on depression, these studies tended to have only short-term follow-ups and some had additional study limitations (e.g., relatively high levels of missing data on depression). Thus, a well-conducted RCT with a longer-term follow-up period is needed to determine whether 123-MOMS can produce meaningful impacts that are sustained beyond a few months.

This RCT will randomly assign 300 pregnant women to either (i) a treatment group that will receive MOMS-123 as well as iPads with data connectivity to implement the intervention or to (ii) a control group that will be provided with iPads and data connectivity and will have access to usual community services. Women are eligible to participate in the study if they are in their second trimester of pregnancy, living below 250% of the federal poverty level, and have symptoms of depression. Under this project, the study will measure the program’s effect on two primary outcomes: maternal depression and child cognitive development through one year post-intervention. These outcomes will be measured using standardized and well-established assessments (i.e., the Center for Epidemiologic Studies Depression Scale (CES‑D) and the Bayley‑4 assessment of infant cognitive development). Secondary outcomes will include birth weight, gestational age at delivery, language and socio-emotional development, maternal employment, and earnings.

The study’s pre-specified analysis plan is linked here.