Recruiting

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

ClinicalTrials.gov IDNCT07722949

PhaseNA

Enrollment77

SponsorKhyber Medical University Peshawar

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Autism Spectrum Disorder, Psychological Distress, Depression, Anxiety

About this study

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.

Interventions

Behavioral: Culturally 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.
Other: Routine 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.

Primary outcomes

Change in Depression Score (Baseline and 1 month after completion of the intervention.)
Anxiety (Baseline and 1 month after completion of the intervention.)
Stress (Baseline and 1 month after completion of the intervention.)

Eligibility information

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.

Study locations

Children Hospital Complex and Institute of Child Health, Faisalābad, Punjab Province 38000 Pakistan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.