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

Not Applicable

Not yet recruiting

• Conditions: Prenatal Anxiety; Prenatal Depression; Maternal Sensitivity

• Registration Number: NCT06726304
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief 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).

Detailed Description

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months	From the beginning of recruitment to the end of the last assessment (at 16 weeks postpartum)	To assess the feasibility of the baby carrier intervention, including recruitment, enrollment, and retention rates, using the ratio of eligible versus enrolled participants and enrolled versus retained participants.

Secondary Outcome Measures

Name	Time	Method
Acceptability: Adherence to the baby carrier intervention	From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)	Acceptability will be evaluated based on i) compliance with the prescribed length of baby carrier usage according to self-reports, ii) rating the burden of the protocol low-moderate, and iii) report benefits associated with babywearing in the interview.

Trial Locations

Locations (1)

Lady Davis Institute of the Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada