Clinical trial NCT06726304: Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.
Official title: A Pilot Intervention Study to Increase Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prenatal Anxiety
Prenatal Depression
Maternal Sensitivity
Keywords: baby carrier
maternal sensitivity
inter-personal neural synchrony
perinatal anxiety
perinatal depression
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Brain Canada
First posted: 2024-12-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioural intervention with rolling recruitment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months
timeFrame: From the beginning of recruitment to the end of the last assessment (at 16 weeks postpartum)
Secondary outcomes:
measure: Acceptability: Adherence to the baby carrier intervention
timeFrame: From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)
Other outcomes:
measure: Utility of the baby carrier intervention
timeFrame: From baseline assessment (at week 8) to final assessment (at week 16) of maternal sensitivity
measure: Inter-personal Neural Synchrony
timeFrame: During the second home visit (at week 16 postpartum)
measure: Qualitative Analysis of Maternal Experiences with Babywearing
timeFrame: During the second home visit (at week 16 postpartum)
Locations:
city: Montreal
country: Canada
facility: Lady Davis Institute of the Jewish General Hospital
state: Quebec
Study officials:
References: