Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.

Enrolling by invitation · Not applicable

Conditions studied: Prenatal Anxiety, Prenatal Depression, Maternal Sensitivity

In brief

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).

Key facts

Study ID

NCT06726304

Run by

Sir Mortimer B. Davis - Jewish General Hospital

People needed

40

Starts

2025-02-12

Expected to finish

2027-05-31

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• be able to communicate in English or French
• diagnosed with a depressive or anxiety disorder (or both) during their intake visit within the Perinatal Multisite Databank (PMD)
• residing in the greater Montreal area
• have given birth to a healthy baby

You may not qualify if…

• having known alcohol or substance use issues,
• having been diagnosed with psychosis or schizophrenia during the PMD intake assessment, or have had thoughts of harming the self or the baby
• having physical restrictions that may prevent the regular use of a baby carrier
• taking any medications regularly that cause potential participants to feel drowsy or dizzy
• already using a baby carrier with their current baby for more than 5 hours a week

Where it is running

• Lady Davis Institute of the Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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