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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Children Hospital Complex and Institute of Child Health
RECRUITING
Faisalābad
Contact Information
Primary
Zeenaf Aslam, RN, MSN,PHD*
zeenafch@gmail.com
+92 332 6613345
Backup
Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
coordinator.ctu@kmu.edu.pk
+923460113227
Time Frame
Start Date: 2026-07-15
Estimated Completion Date: 2027-05-25
Participants
Target number of participants: 77
Treatments
Experimental: Culturally Adapted Nurse-Led COPE Intervention
Participants randomized to the experimental arm will receive a culturally adapted, nurse-led Creating Opportunities for Parent Empowerment (COPE) intervention in addition to routine hospital care. The intervention consists of four weekly sessions (approximately 45 minutes each) delivered over four weeks by trained nurses. The sessions include psychoeducation about Autism Spectrum Disorder (ASD), cognitive restructuring, coping strategies, positive parenting, emotional regulation, stress management, and long-term family resilience. Educational materials, including audio-visual aids and printed booklets, will be used to facilitate the intervention.
Other: Routine Care
Participants randomized to the control arm will receive routine hospital care only. They will not receive the culturally adapted nurse-led COPE intervention during the study period. Psychological wellbeing will be assessed at the same time points as the intervention group using the study outcome measures.
Related Therapeutic Areas
Sponsors
Collaborators: Children Hospital Faisalabad
Leads: Khyber Medical University Peshawar

This content was sourced from clinicaltrials.gov