123-MOMS: RCT Evaluation of a Three-Phase Intervention on Maternal Mental Health and Child Development to Lay the Foundations for Economic Opportunity and Wellbeing.

Last registered on October 15, 2022

Pre-Trial

Trial Information

General Information

Title
123-MOMS: RCT Evaluation of a Three-Phase Intervention on Maternal Mental Health and Child Development to Lay the Foundations for Economic Opportunity and Wellbeing.
RCT ID
AEARCTR-0006445
Initial registration date
September 14, 2020

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 18, 2020, 2:17 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
October 15, 2022, 8:32 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
Yale University

Other Primary Investigator(s)

PI Affiliation
Yale School of Medicine and Child Study Center
PI Affiliation
Yale University, Department of Economics
PI Affiliation
Yale School of Meddicine and Child Study center
PI Affiliation
Yale Child Study Center

Additional Trial Information

Status
In development
Start date
2022-10-01
End date
2026-07-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
A key mechanism for the perpetuation of poverty across generations is the accumulated developmental deficits of children from deprived backgrounds, who often lack a nurturing and stimulating environment. Moreover, poverty is associated with an incidence of maternal depression of at least 50%, which, in turn leads to reduced economic opportunities and reduced engagement with children potentially perpetuating poverty intergenerationally. Addressing these effects of poverty on maternal mental health and on child development is an urgent policy matter. We propose to test an intervention delivered virtually via Telehealth with sequential complementary components: (i) Cognitive Behavioral Therapy and information about parenting skills for low-income pregnant women with depressive symptoms; and (ii) group sessions fostering child stimulation until the child is 15 months old. To evaluate the impacts, we will recruit approximately 500 low-income women with depressive symptoms and allocate them randomly to treatment and control. Outcomes will include child development measured by the Bayley and maternal and child health and development indicators available in the electronic medical records, as well as mother’s mental health and economic outcomes. Long term follow-up will eventually allow a better understanding of the impact of human capital interventions on both mother and child.
External Link(s)

Registration Citation

Citation
Attanasio, Orazio et al. 2022. "123-MOMS: RCT Evaluation of a Three-Phase Intervention on Maternal Mental Health and Child Development to Lay the Foundations for Economic Opportunity and Wellbeing.." AEA RCT Registry. October 15. https://doi.org/10.1257/rct.6445-2.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
The target population are low-income pregnant women with depressive symptoms. The intervention contains three components:

Cognitive Behavioral Therapy from recruitment in the second trimester of pregnancy until birth, followed by parenting sessions promoting mother child attachment, immediately after birth. We then implement a version of Reach-up and Learn to promote child stimulation.

The intervention will be delivered online and will involve groups
Intervention Start Date
2022-10-01
Intervention End Date
2025-07-31

Primary Outcomes

Primary Outcomes (end points)
Maternal Mental Health, Child Cognitive and Language Development.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary outcomes will include parenting quality (Parent Child Relationship Inventory), social connectedness and substantiated child welfare referrals. We will also evaluate access to and use of welfare programs, child care facilities and other services. At endline we will collect information on maternal employment and earnings.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Women who attend the Yale/New Haven health system will be recruited and once consent has been obtained as well as baseline data they will be screened for eligibility and depression. Eligible women will be randomized to treatment and control group, forming groups of about 6-8 treated women and 6-8 women in control. Both treatment and control group will receive a tablet with internet connection as well as basic services (information on safe sleep and nutrition for their children.) Once a group is formed the intervention will start for the group randomized into treatment.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer
Randomization Unit
The randomization unit is an individual.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
The designed is not clustered.
Sample size: planned number of observations
300 women and their newborn child.
Sample size (or number of clusters) by treatment arms
150 women in treatment, 150 in control (with tablet)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.32 of a standard deviation
IRB

Institutional Review Boards (IRBs)

IRB Name
Yale University IRB
IRB Approval Date
2021-07-13
IRB Approval Number
2000029148
Analysis Plan

Analysis Plan Documents

123 Moms Preanalysis Plan

MD5: 8033bb7fc6ba078db41d048e42328873

SHA1: 7e65f514598fe86a7c938fefac8c81fbd0781523

Uploaded At: October 15, 2022