RecruitingNot ApplicableNCT07722949

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)

Sponsor

Khyber Medical University Peshawar

Enrollment

77 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Psychological Distress Depression Anxiety Autism Spectrum Disorder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Culturally Adapted Nurse-Led COPE Intervention and Routine Hospital Care for people with anxiety, autism spectrum disorder, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCulturally Adapted Nurse-Led COPE Intervention

The intervention is a culturally adapted, nurse-led behavioral and psychoeducational program based on the Creating Opportunities for Parent Empowerment (COPE) framework. It is designed to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) by enhancing coping skills, emotional regulation, problem-solving abilities, and parenting confidence. The intervention comprises four weekly sessions of approximately 45 minutes each and includes education about ASD, cognitive restructuring, stress management, positive parenting strategies, guided problem-solving, and development of long-term coping and family resilience. The program is delivered by trained nurses using standardized educational materials, including presentations, audiovisual aids, and printed booklets.

OTHERRoutine Hospital Care

Participants receive the standard care routinely provided by the hospital for families of children with Autism Spectrum Disorder. No components of the culturally adapted nurse-led COPE intervention are provided during the study period.