Condition: Autism Spectrum Disorder · Psychological Distress · Depression · Sponsor: Khyber Medical University Peshawar
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.
This description comes directly from the study's public registry record.
Zeenaf Aslam, RN, MSN,PHD* · +92 332 6613345 · zeenafch@gmail.com
Dr Syed Muhammad Shabbir Ali Naqvi, PhD* · +923460113227 · coordinator.ctu@kmu.edu.pk
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| Children Hospital Complex and Institute of Child Health | Faisalābad, Punjab Province, Pakistan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07722949