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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Primary completion date: Jan 2026 to Apr 30, 2027
    • Study completion date: May 2026 to May 31, 2027
    • Start date changed from estimate of Jan 2025 to Feb 12, 2025
    • Site contact updated
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06726304
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Collaborators: Brain Canada
Conditions
(from sponsor)
Prenatal Anxiety, Prenatal Depression, Maternal Sensitivity
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov