Coparenting Intervention to Prevent Postpartum Depression

Anxiety Clinical Trial

Official title:

eHealth Antenatal Coparenting Intervention to Prevent Postpartum Depression Among Primiparous Women, Karachi, Pakistan: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06305325
• Other study ID #: 35957
• Status: Completed
• Phase: N/A
• Start date: September 23, 2018
• Est. completion date: February 22, 2020

Study information

• Verified date: March 2024
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 22, 2020
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	SinDH

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	University of Toronto

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. — View 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. — View 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. — View 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

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Depressive Symptoms	Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure, asking about the depressive symptomatology during the past week. It is a reliable and valid instrument with a sensitivity of 85% and specificity of 77%. The sensitivity of the Urdu version is 98%. Each item is scored on a four-point scale with a total score ranges from 0-30. The minimum is 0 and the maximum total score is 30. Couples who score greater than twelve are likely to be suffering from depressive symptomatology.	baseline, 4-6 weeks and 12-weeks postpartum
Secondary	anxiety	The State-Trait Anxiety Inventory (STAI) is a twenty item self-report questionnaire with each item scored on a four-point Likert scale; 1 = "not at all" to 4 = "very much so", with a total score ranging from 20 to 80. Couples who score > 40 are likely to be suffering symptoms of anxiety. Internal consistency of the STAI-S ranges from 0.91 to 0.95. The coefficient alpha of the Urdu version was 0.87.	baseline, 4-6 weeks and 12-weeks postpartum
Secondary	Coparenting Relationship	The Coparenting Relationship Scale (CRS) was used to measure coparental quality in couples. The CRS is a thirty-five item self-report questionnaire, consisting of seven subscales. It has good reliability and strong stability with Cronbach's alphas ranging from 0.91 to 0.94 across genders. Each item is scored on a seven-point Likert scale from "that is not true of us" (score 0) to "very true of us" (score 6). Six of the scales are scored on the same Likert scale except exposure to conflict scale which is scored on six-point Likert scale from "never" (score 0) to "several times a week" (score 6). The CRS tool is in English and was translated into Urdu. The Urdu version was back translated into English. the pilot testing of the tool was done with ten pregnant couples from a community Health Center (CHC), an out-patient clinic at the Aga Khan University Hospital (AKUH), were asked to complete the scale.	baseline, 4-6 weeks and 12-weeks postpartum
Secondary	Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship.	The Revised Dyadic Adjustment Scale (RDAS) was used to measure couple relationship satisfaction and discriminate between distressed and non-distressed relationship. The RDAS has 14 items, each of which asks the respondents to rate certain aspects of their relationship on a six-point Likert scale. Only one question "Do you and your mate engage in outside interests together"? ask the respondents to rate on a five-point Likert scale. Scores on the RDAS range from 0 to 69 with higher scores indicating greater relationship satisfaction and lower scores indicating greater relationship distress. The cut-off score for the RDAS was = 48 such that scores of 48 and above indicate non-distress and scores of 47 and below indicates relationship distress. Cronbach's alpha for the RDAS is 0.90. The RDAS has been used in the postpartum population in previous studies.	baseline, 4-6 weeks and 12-weeks postpartum
Secondary	Postpartum Childcare Stress	The Postpartum Childcare Stress Checklist (PCSC) was used to identify parental perceptions of childcare stress. The PCSC has 19 items, asking the participants to rate their experience of events mentioned in the items over the past 4 weeks. Each item is rated as "yes or (1)" or "No or (2)". The PCSC explores the participant's experience related to the relationship with the partner, caring for the infant, social interactions, and establishing a new routine. Scores on the PCSC range from 1 to 19 with higher scores indicating lower childcare stress and lower scores indicating greater childcare stress. The PCSC had internal consistency of 0.81 (Dennis et al., 2018). The PCSC tool is available in English and was translated into Urdu. The Urdu version was back translated into English. The tool has not been used in Pakistan and has not been tested for reliability and validity for this population	12-weeks postpartum
Secondary	Infant Development	The Ages and Stages Questionnaire (ASQ-3) was used to identify infants at risk of delays in development at communication, gross motor, fine motor, problem solving, and personal-social domains at 12-week postpartum. The ASQ-3 is comprised of 30 age-appropriate questions to which parents respond with three categories: yes (10 points), sometimes (5 points), and not yet (0 points). Scores for each area range from 0 to 60 with higher scores indicating lower risk of delays in overall development. It is a reliable and valid instrument with a sensitivity and specificity of 87.4% and 95.7% respectively	12 weel postpartum
Secondary	partner support	The Postpartum Partner Support Scale (PPSS) is a new instrument, which was used to measure postpartum partner support in couples. The PPSS tool is a twenty-item self-report, asking about the partner support during the past four weeks. Each item is scored on a four-point Likert scale; 1 = "Strongly Disagree" to 4 = "Strongly Agree. Higher scores are indicative of a more positive partner support. The Cronbach's alpha for the PPSS is 0.96. The PPSS tool is available in English and was translated into Urdu.	baseline and 12 weeks postpartum