Culturally tailored nurse-led COPE program for caregivers of children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a two-phase design starting with qualitative interviews to identify caregiver needs and adapt the COPE intervention for the Pakistani context. A pilot randomized feasibility trial will then enroll eligible caregivers to receive either the culturally adapted COPE program plus routine care or routine care alone. The COPE program includes four weekly sessions focusing on psychoeducation, cognitive restructuring, coping strategies, positive parenting, emotional regulation, and family resilience. Outcomes will assess feasibility and preliminary signals of impact on caregiver psychological wellbeing. The trial aims to inform larger studies and expand access to caregiver support in settings with limited mental health resources.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children Hospital Complex and Institute of Child Health
  Faisalābad, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Zeenaf Aslam, RN, MSN,PHD* — Institute of Nursing Sciences, Khyber Medical University Peshawar
• Study coordinator: Zeenaf Aslam, RN, MSN,PHD*
• Email: zeenafch@gmail.com
• Phone: +92 332 6613345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.