A Pilot Intervention Study To Increase Physical Contact Between Prenatally Anxious/Depressed Mothers And Their Infants To Improve Maternal Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months
研究概览
简要总结
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).
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Baby Carrier Intervention (Behavioral)
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.
结局指标
主要结局
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months
时间窗: 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.
次要结局
- 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))
研究者
Eszter Szekely
Co-Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital