Clinical trial NCT06305325: Coparenting Intervention to Prevent Postpartum Depression
Official title: eHealth Antenatal Coparenting Intervention to Prevent Postpartum Depression Among Primiparous Women, Karachi, Pakistan: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Anxiety
Keywords: online
postpartum depression
Coparenting relationship
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2024-03-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: coparenting framework: it has 3 levels. First is the individual level, which consists of the parent's individual characteristics, which comprises of attitudes, parental beliefs, and emotional and mental health. It has a bidirectional relationship with coparenting and the overall inter-parental relationship. Individual child factors, such as temperament may also play a role in shaping the coparenting relationship. The second level is the family level. It comprises the overall interpersonal relationship, referring to the existing ability of couples to demonstrate support and respect for each other. It could influence the coparental relationship or in reverse, the coparental relationship may influence the overall inter-parental relationship. The third level is the extra-familial level. It has two components: support and stress that are based on a stress-coping perspective. The role of environmental support is viewed as enhancing the coparenting relationship
Primary purpose: PREVENTION

Brief summary: The goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eACoP) in primiparous Pakistani women. The secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. Two hundred and twelve primiparous couples were randomized into an intervention or a control group from the Aga Khan University Hospital. Couples were randomized using consecutively numbered sealed envelopes. Couples in the intervention group received the eACoP intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. Both the intervention group and control group received standard care.


Eligibility criteria: Inclusion Criteria:

* primiparous
* Both women and their partners willing to participate and indicated by signed consent
* Up to 24 weeks of gestation (first and second trimester of pregnancy)
* Singleton pregnancy
* Able to speak, read, and understand English or Urdu
* Have access to internet

Exclusion Criteria:

* Did not have access to internet
* Had an EPDS score of \>12.

Primary outcomes:
measure: feasibility-recruitment rate, adherence, and follow-up rate
timeFrame: recruitment-at the time of recruitment during pregnancy pre intervention, adherence rate-during the intervention, follow up rate- 6 weeks and 12 weeks after the delivery of an infant
measure: Acceptability- Participants satisfaction
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: baseline, 4-6 weeks and 12-weeks postpartum
measure: anxiety
timeFrame: baseline, 4-6 weeks and 12-weeks postpartum
measure: Coparenting Relationship
timeFrame: baseline, 4-6 weeks and 12-weeks postpartum
measure: Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship.
timeFrame: baseline, 4-6 weeks and 12-weeks postpartum
measure: Postpartum Childcare Stress
timeFrame: 12-weeks postpartum
measure: Infant Development
timeFrame: 12 weel postpartum
measure: partner support
timeFrame: baseline and 12 weeks postpartum
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: SinDH
Study officials:
affiliation: Brock University
name: Salima Sulaiman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dennis CL, Brown HK, Brennenstuhl S. The Postpartum Partner Support Scale: Development, psychometric assessment, and predictive validity in a Canadian prospective cohort. Midwifery. 2017 Nov;54:18-24. doi: 10.1016/j.midw.2017.07.018. Epub 2017 Jul 29.
citation: Dennis CL, Brown HK, Brennenstuhl S. Development, Psychometric Assessment, and Predictive Validity of the Postpartum Childcare Stress Checklist. Nurs Res. 2018 Nov/Dec;67(6):439-446. doi: 10.1097/NNR.0000000000000308.
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citation: Spanier, G. B. (1976). Measuring dyadic adjustment: New scales for assessing the quality of marriage and similar dyads. Journal of Marriage and the Family, 38(1), 15-28. https://doi.org/10.2307/350547
citation: Squires, J. & Bricker, D. (2009). Ages & Stages Questionnaires [R], (ASQ-3): A Parent- Completed Child-Monitoring System. Brookes Publishing Company.
citation: Feinberg ME, Brown LD, Kan ML. A Multi-Domain Self-Report Measure of Coparenting. Parent Sci Pract. 2012 Jan 1;12(1):1-21. doi: 10.1080/15295192.2012.638870. Epub 2012 Jan 20.