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A Pilot Intervention Study to Increase Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity
The goal of this randomized controlled pilot trial is to evaluate the feasibility, acceptability, and clinical utility of a baby carrier intervention aimed at improving maternal sensitivity and mother-infant bonding in prenatally anxious/depressed mothers. The study has three main questions: 1. Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)? 2. Does the intervention improve maternal sensitivity compared to a waitlist control group? 3. Does the intervention increase mother-infant neural synchrony compared to a waitlist control group, measured using functional near-infrared spectroscopy? Participants will A. Choose between two soft ergonomic baby carriers and be expected to use the baby carrier for the prescribed amount of time (intervention group). B. Have two home visits, one at the start (at postpartum week 8) and another one at the end of the study (at postpartum week 16). C. Complete questionnaires about depression and anxiety symptoms, mother-infant bonding, and rate protocol burden. D. Share their feelings and lived experiences about the frequent use of a baby carrier and increased physical contact with their baby through open-ended interview questions (intervention group).
The intervention involves mothers in the experimental group using a soft ergonomic baby carrier for a prescribed amount of time over a period of six weeks. Weekly adherence self-reports will be collected via REDCap. Participants will be recruited from the Perinatal Multisite Databank (PMD), an ongoing clinical cohort of individuals receiving psychiatric services during pregnancy and the first six months postpartum in the province of Quebec, Canada.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Lady Davis Institute of the Jewish General Hospital
Montreal, Quebec, Canada
Start Date
January 1, 2025
Primary Completion Date
January 1, 2026
Completion Date
May 1, 2026
Last Updated
December 10, 2024
40
ESTIMATED participants
Baby Carrier Intervention
BEHAVIORAL
Lead Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Collaborators
Data Source & Attribution
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