NCT07722949 Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder
| NCT ID | NCT07722949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Khyber Medical University Peshawar |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 77 participants in total. It began in 2026-07-15 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zeenaf Aslam, RN, MSN,PHD*
PRINCIPAL INVESTIGATOR
Institute of Nursing Sciences, Khyber Medical University Peshawar
Frequently Asked Questions
Who can join the NCT07722949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07722949 currently recruiting?
Yes, NCT07722949 is actively recruiting participants. Contact the research team at zeenafch@gmail.com for enrollment information.
Where is the NCT07722949 trial being conducted?
This trial is being conducted at Faisalābad, Pakistan.
Who is sponsoring the NCT07722949 clinical trial?
NCT07722949 is sponsored by Khyber Medical University Peshawar. The principal investigator is Zeenaf Aslam, RN, MSN,PHD* at Institute of Nursing Sciences, Khyber Medical University Peshawar. The trial plans to enroll 77 participants.