Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With A… (NCT07722949) | Clinical Trial Compass
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Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder
Pakistan77 participantsStarted 2026-07-15
Plain-language summary
This study aims to evaluate the feasibility of a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) in Pakistan. The study will use an exploratory sequential mixed-methods design comprising a qualitative needs assessment followed by a pilot randomized controlled feasibility trial. Qualitative interviews will identify caregivers' training needs and inform the cultural adaptation of the COPE intervention. Eligible caregivers will then be randomly assigned to either an intervention group receiving the culturally adapted COPE program in addition to routine care or a control group receiving routine care alone. The intervention consists of four weekly nurse-led sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Psychological wellbeing will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21) at baseline and one month after the intervention. The study will also evaluate recruitment, retention, intervention adherence, acceptability, and implementation feasibility to inform the design of a future definitive randomized controlled trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female primary caregivers aged 18 years or older.
* Primary caregiver of a child with a confirmed diagnosis of Autism Spectrum Disorder (ASD).
* Able to communicate in Urdu.
* Willing and able to provide written informed consent.
* Available to attend all intervention sessions and follow-up assessments.
Exclusion Criteria:
* Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.
* Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.
* Caregivers unable to communicate effectively in Urdu.
* Caregivers who decline or are unable to provide informed consent.
* Caregivers who are unavailable to complete the intervention or follow-up assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Depression Score
Timeframe: Baseline and 1 month after completion of the intervention.
2
Anxiety
Timeframe: Baseline and 1 month after completion of the intervention.
3
Stress
Timeframe: Baseline and 1 month after completion of the intervention.