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Postpartum DepressionNCT06305325

Coparenting Intervention to Prevent Postpartum Depression

A study testing eHealth Antenatal Coparenting Intervention in people with Postpartum Depression and Anxiety, run by Brock University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Postpartum Depression, Anxiety
What is being tested?
eHealth Antenatal Coparenting Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 sitePakistan
Study dates
23 Sep 2018to 22 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Aga Khan University

    Karachi, Sindh

Other trials in Pakistan

About this study

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

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.

Being tested
eHealth Antenatal Coparenting Intervention
Keywords
online, postpartum depression, Coparenting relationship
Medical subject headings
Depression, Postpartum, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eHealth Antenatal Coparenting InterventionBehavioural

    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

Study groups in NCT06305325
Study groupRoleWhat they receive
Control GroupNo interventioncontrol 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 InterventionExperimentalThis 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
Receives: Behavioral: eHealth Antenatal Coparenting Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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.

    Measured: immediately after the intervention

Secondary outcomes (7)

  1. 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.

    Measured: baseline, 4-6 weeks and 12-weeks postpartum

  2. 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.

    Measured: baseline, 4-6 weeks and 12-weeks postpartum

  3. 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.

    Measured: baseline, 4-6 weeks and 12-weeks postpartum

  4. 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.

    Measured: baseline, 4-6 weeks and 12-weeks postpartum

  5. 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

    Measured: 12-weeks postpartum

  6. 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

    Measured: 12 weel postpartum

  7. 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.

    Measured: baseline and 12 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start23 Sep 2018
  3. Primary completion22 Nov 2019
  4. Study completion22 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305325
Sponsor's protocol ID
35957
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD are confidential and linked to participants ID. I am bound with Ethics Review to nor disclose their information

Publications

  • 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.

    PubMed 3651732

  • 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.

    PubMed 28780475

  • 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.

    PubMed 30067584

  • 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.

  • 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

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

  • 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.

    PubMed 23166477

Questions about this trial

What is this clinical trial studying?

A study testing eHealth Antenatal Coparenting Intervention in people with Postpartum Depression and Anxiety, run by Brock University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06305325, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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