Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.
NCT ID: NCT06726304
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-31
2026-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Baby Carrier Intervention Group
Participants and their babies will be visited twice by trained research staff in their home. Once at the beginning of the study (at 8 weeks postpartum) and for a second time at the end of the study (at 16 weeks postpartum). During the first visit, mothers will choose between two soft ergonomic baby carriers and be given instructions regarding the expected frequency and length of usage. Maternal sensitivity will be observed during a 15-minute free play session of the mother-baby dyad. During the second home visit, inter-personal neural synchrony in mother-baby dyads will be assessed during a joint attention task (9 minutes). Participants will also be interviewed about their lived experiences with babywearing and increased physical contact with their baby (30-40 minutes). Finally, participants will complete questionnaires about mother-infant bonding, depression and anxiety symptoms, and rate the burden of the protocol.
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.
Waitlist Control Group
The waitlist control group will be assessed using the same measures as the intervention group (described above) except for the open-ended interview questions about their lived experiences with regular babywearing and increased physical contact with their baby.
At the end of the second home visit, all waitlist control participants will be offered to choose between the same two ergonomic baby carrier models as the intervention group, and will be provided with the same instructions regarding the recommended frequency and length of use as intervention group participants at the beginning of the study.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Brain Canada
OTHER
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
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Eszter Szekely
Co-Principal Investigator
Locations
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Lady Davis Institute of the Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Eszter Szekely, PhD
Role: primary
Other Identifiers
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2024-989
Identifier Type: -
Identifier Source: org_study_id