eHealth Antenatal Coparenting Intervention to Prevent Postpartum Depression Among Primiparous Women, Karachi, Pakistan: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brock University
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- feasibility-recruitment rate, adherence, and follow-up rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Control Group
control group received the standard care. It included antenatal classes offered at the CC clinic, which comprised of four face-to-face sessions in clinic. These classes focus on pregnancy and postpartum care including baby growth in each trimester, minor discomforts, diet, exercise, personal hygiene, complications during pregnancy, labour and delivery stages, breastfeeding, care of newborn baby, and family planning methods. The 2-3 hour long face-to-face classes are offered every week on Saturdays in the clinic
eHealth antenatal Coparenting Intervention
This intervention focuses on developing conflict management, problem solving, communication, and mutual support to foster positive joint parenting of an infant. A modification in the delivery of this intervention was made in the current study in order to make it deliver online. The eACoP intervention included eight antenatal videos from Feinberg's Family Foundation intervention. A website for the eACoP intervention was developed, and all the videos were uploaded to the website. These videos were 30-40 minutes each. The videos were in English and subtitles in Urdu were added to the videos. These videos were accompanied by an activity-based coparenting workbook. The coparenting workbook includes a worksheet and homework for each video and was also translated into Urdu
Intervention: eHealth Antenatal Coparenting Intervention (Behavioral)
Outcomes
Primary Outcomes
feasibility-recruitment rate, adherence, and follow-up rate
Time Frame: 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
feasibility refers to how well the eACoP intervention was implemented. It included recruitment rate, adherence, and follow-up rate. The recruitment log was completed to assess the recruitment rate by the Research Assistant (RA) at the time of recruitment and used to determine a) eligibility rate; b) enrollment rate; c) refusal rates; and d) reasons for non-participation. The eligibility rate was defined as the percentage of screened people who met eligibility criteria. The enrollment rate was defined as the percentage of eligible couples who consented to take part in the study. The intervention Activity Log was completed by the RA weekly by telephone to assess the adherence rate and used to determine a) compliance with intervention material and reasons for non-compliance; and b) completion of workbook and reasons for not completion. The non-compliance form was used to assess reasons for non-compliance. The follow-up rate recorded on follow-up log
Acceptability- Participants satisfaction
Time Frame: immediately after the intervention
It is a 14-item self-report questionnaire designed to measure an individual's satisfaction with an intervention which also included four open ended questions. Higher scores indicate higher levels of satisfaction.
Secondary Outcomes
- Coparenting Relationship(baseline, 4-6 weeks and 12-weeks postpartum)
- anxiety(baseline, 4-6 weeks and 12-weeks postpartum)
- Depressive Symptoms(baseline, 4-6 weeks and 12-weeks postpartum)
- partner support(baseline and 12 weeks postpartum)
- Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship.(baseline, 4-6 weeks and 12-weeks postpartum)
- Postpartum Childcare Stress(12-weeks postpartum)
- Infant Development(12 weel postpartum)
Investigators
Salima Sulaiman
Assistant Professor
Brock University