Early intervention on mother-child interaction and screen use. Impact on children's mental health and development.

Last registered on March 07, 2025
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Pre-Trial

Trial Information

General Information

Title
Early intervention on mother-child interaction and screen use. Impact on children's mental health and development.
RCT ID
AEARCTR-0015504
Initial registration date
March 05, 2025

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
March 07, 2025, 8:27 AM EST

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

Locations

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Primary Investigator

Name
Marion Goussé
Affiliation
CREST-ENSAI
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Other Primary Investigator(s)

PI Name
Hélène Le Forner
PI Affiliation
Université de Rennes - CREM
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PI Name
Avner Seror
PI Affiliation
CNRS - AMSE
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Additional Trial Information

Status
In development
Start date
2025-04-01
End date
2027-04-01
Keywords
Education
Additional Keywords
JEL code(s)
D10, D91, Z10
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
We are evaluating the effect of a family intervention for mothers who have just given birth. The intervention consists of 16 hours of counseling and home support during the baby's first month. We assess the impact of this intervention on the quality of the mother-child relationship, the mental health of young mothers, and the child's development. We also evaluate the effect of an enhanced treatment that warns about the harmful use of screens on the quality of interactions.
External Link(s)

Registration Citation

Citation
Goussé, Marion, Hélène Le Forner and Avner Seror. 2025. "Early intervention on mother-child interaction and screen use. Impact on children's mental health and development.." AEA RCT Registry. March 07. https://doi.org/10.1257/rct.15504-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2025-04-01
Intervention End Date
2027-04-01

Primary Outcomes

Primary Outcomes (end points)
Mental health of mothers at 1month after birth and 6 months after birth.
Physical development of the child at 1 month and at 6 months.
Quality of the mother child interaction at 1 month and at 6 month.
Effect of the standard intervention and the intervention focused on screen usage.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
At birth, mothers are selected by midwives and nurses to receive a home intervention from a trained care professional who helps them care for their newborn and provides advice.
Among the selected mothers, we will randomize the type of support they receive from the trained care professional—either standard assistance or assistance with a specific focus on screen usage and child development.
We will also establish a control group by working with midwives and nurses to collect data from mothers who were nearly selected for the intervention but were excluded due to budget constraint.
At the end of the intervention, we will collect data through a self-administered survey conducted in the presence of the trained care professional. We will also collect data six months later through a self-administered online survey. For the control group, we will also collect data one month after birth through a self-administered online survey.
Experimental Design Details
Not available
Randomization Method
randomization done in office by a computer
Randomization Unit
Randomization unit is a couple mother-child.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
No clusters.
Sample size: planned number of observations
We expect 300 mothers over 2 years. 230 mothers who receive the intervention and 70 mothers in the control group.
Sample size (or number of clusters) by treatment arms
115 mothers for the first treatment, 115 mothers for the second treatment and 70 mothers in the control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Comité d’éthique de la Recherche de l’Université d’Aix-Marseille
IRB Approval Date
2024-12-12
IRB Approval Number
2024-01-23-02
Analysis Plan