Coparenting Intervention to Prevent Postpartum Depression

NCT06305325 | Completed

• 1 other identifier: 35957
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Anxiety

Keywords

online; postpartum depression; Coparenting relationship

Outcome Measures

Primary Outcomes (2)

• feasibility-recruitment rate, adherence, and follow-up rate

  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

  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

• Acceptability- Participants satisfaction

  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.

  immediately after the intervention

Secondary Outcomes (7)

• Depressive Symptoms

  baseline, 4-6 weeks and 12-weeks postpartum

• anxiety

  baseline, 4-6 weeks and 12-weeks postpartum

• Coparenting Relationship

  baseline, 4-6 weeks 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

Study Arms (2)

Control Group

NO INTERVENTION

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

EXPERIMENTAL

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

Behavioral: eHealth Antenatal Coparenting Intervention

Interventions

eHealth Antenatal Coparenting Intervention BEHAVIORAL

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

eHealth antenatal Coparenting Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brock University: lead
• University of Toronto: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

Location

Related Publications (7)

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• 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.

  PMID: 28780475 BACKGROUND

• 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.

  PMID: 30067584 BACKGROUND

• Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

  BACKGROUND

• 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

  BACKGROUND

• Squires, J. & Bricker, D. (2009). Ages & Stages Questionnaires [R], (ASQ-3): A Parent- Completed Child-Monitoring System. Brookes Publishing Company.

  BACKGROUND

• 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.

  PMID: 23166477 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Salima Sulaiman, PhD

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: September 23, 2018
• Primary Completion: November 22, 2019
• Study Completion: February 22, 2020
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)