Prenatal AnxietyNCT06726304
Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.
A study testing Baby Carrier Intervention in people with Prenatal Anxiety and Prenatal Depression, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Anxiety, Prenatal Depression, Maternal Sensitivity
- What is being tested?
- Baby Carrier Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Lady Davis Institute of the Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Pilot Intervention Study To Increase Physical Contact Between Prenatally Anxious/Depressed Mothers And Their Infants To Improve Maternal Sensitivity
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:
- Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)?
- Does the intervention improve maternal sensitivity compared to a waitlist control group?
- Does the intervention increase mother-infant neural synchrony compared to a waitlist control group, measured using functional near-infrared spectroscopy?
Read more
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).
- 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).
- Complete questionnaires about depression and anxiety symptoms, mother-infant bonding, and rate protocol burden.
- 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).
Read the 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.
- Conditions
- Prenatal Anxiety, Prenatal Depression, Maternal Sensitivity
- Being tested
- Baby Carrier Intervention
- Keywords
- baby carrier, maternal sensitivity, inter-personal neural synchrony, perinatal anxiety, perinatal depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Carrier InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Baby Carrier Intervention Group | Experimental | 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. Receives: Behavioral: Baby Carrier Intervention |
| Waitlist Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months
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.
Measured: From the beginning of recruitment to the end of the last assessment (at 16 weeks postpartum)
Secondary outcomes (1)
Acceptability: Adherence to the baby carrier intervention
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.
Measured: From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start12 Feb 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioural intervention with rolling recruitment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada
- Responsible party
- Principal investigator, Eszter Szekely, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726304
- Sponsor's protocol ID
- 2024-989
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention Study To Increase Physical Contact Between Prenatally Anxious/Depressed Mothers And Their Infants To Improve Maternal Sensitivity
- ClinicalTrials.gov ID
- NCT06726304
- Acronym / sponsor ID
- 2024-989
- Conditions
- Prenatal Anxiety, Prenatal Depression, Maternal Sensitivity
- Keywords
- baby carrier, maternal sensitivity, inter-personal neural synchrony, perinatal anxiety, perinatal depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- Brain Canada
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)?
- Does the intervention improve maternal sensitivity compared to a waitlist control group?
- 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).
- 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).
- Complete questionnaires about depression and anxiety symptoms, mother-infant bonding, and rate protocol burden.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Behavioural intervention with rolling recruitment
| Arm | Type | Receives |
|---|---|---|
| Baby Carrier Intervention Group | Experimental | Behavioral: Baby Carrier InterventionParticipants 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. |
| Waitlist Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby Carrier InterventionMothers 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. | Behavioural | Baby Carrier Intervention Group |
Primary outcome
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months
Time frame: 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.
1 secondary outcome
Acceptability: Adherence to the baby carrier intervention
Time frame: From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Carrier Intervention in people with Prenatal Anxiety and Prenatal Depression, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months (time frame: From the beginning of recruitment to the end of the last assessment (at 16 weeks postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.