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

NCT06726304 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-28

No results posted yet for this study

Summary

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).

Conditions

  • Prenatal Anxiety
  • Prenatal Depression
  • Maternal Sensitivity

Interventions

BEHAVIORAL

Baby Carrier Intervention

Mothers in the intervention group will have the opportunity to choose between two different soft ergonomic baby carriers and will receive instructions on how to use the carrier of their choice. Infants will be placed chest-to-chest in the carrier, supported by the mother's upper torso for a prescribed amount of time during the period of six weeks.

Sponsors & Collaborators

  • Brain Canada

    collaborator OTHER

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-12
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726304 on ClinicalTrials.gov