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Taking people in PakistanNo phase

Nurse-led coping program for caregivers of children with autism

Tests a culturally adapted nurse-led program supporting caregivers of children with autism.

Plain-language title generated from the registry record
Registry title: Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder

Key facts

Where
Faisalābad, PakistanSee the site

Where in Pakistan

  • Children Hospital Complex and Institute of Child HealthFaisalābad, PakistanTaking people

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Khyber Medical University Peshawar
Trial code
NCT07722949
Record updated
23 July 2026
Original description
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.Read full original descriptionShow less

Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)

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.

Inclusion: 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: Caregivers with a diagnosed severe psychiatric illness or cognitive impairment that would interfere with participation; 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.

ClinicalTrials.gov NCT07722949