Clinical Trial

Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder

Study acronym: COPE-ASD
Recruiting
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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.
Trial Details
NCT Number NCT07722949
Lead Sponsor Khyber Medical University Peshawar
Collaborators: Children Hospital Faisalabad
Conditions Autism Spectrum Disorder, Psychological Distress, Depression, Anxiety
Enrollment 77 participants
Start Date 2026-07-15
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-23