NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07722949

RecruitingNA

Sponsor: Khyber Medical University Peshawar

Conditions: Autism Spectrum Disorder, Psychological Distress, Depression, Anxiety

Interventions: Culturally Adapted Nurse-Led COPE Intervention, Routine Hospital Care

Countries: Pakistan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Faisalābad, Punjab Province, Pakistan