NCT07722949Recruiting
Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder
Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Khyber Medical University Peshawar
- Diseases
- Autism
- NCT number
- NCT07722949
What you commit to
- Study type: Interventional
- Planned participants: 77
- From 15 Jul 2026 to the primary completion date, 30 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation.
Other
- Caregivers currently participating in another structured psychosocial, behavioral, or parenting intervention.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children Hospital Complex and Institute of Child Health Coordinator of this site? Confirm its status | Faisalābad | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.