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

RecruitingNAAges 18 Years - anyAllKhyber Medical University Peshawar
NCT07722949 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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,

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Culturally Adapted Nurse-Led COPE Intervention
  • Routine Hospital Care
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Where

1 site
Children Hospital Complex and Institute of Child Health
Faisalฤbad, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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