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.
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.
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.
Parallel
Culturally Adapted Nurse-Led COPE Intervention
BehavioralThe intervention is a culturally adapted, nurse-led behavioral and psychoeducational program based on the Creating Opportunities for Parent Empowerment (COPE) framework. It is designed to improve the psychological wellbeing of primary caregivers of children with Autism Spectrum Disorder (ASD) by enhancing coping skills, emotional regulation, problem-solving abilities, and parenting confidence. The intervention comprises four weekly sessions of approximately 45 minutes each and includes education about ASD, cognitive restructuring, stress management, positive parenting strategies, guided problem-solving, and development of long-term coping and family resilience. The program is delivered by trained nurses using standardized educational materials, including presentations, audiovisual aids, and printed booklets.
Routine Hospital Care
Other interventionParticipants receive the standard care routinely provided by the hospital for families of children with Autism Spectrum Disorder. No components of the culturally adapted nurse-led COPE intervention are provided during the study period.
Change in Depression Score
Change in depression score measured using the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale. The depression subscale consists of 7 items, each scored from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The summed subscale score is multiplied by 2, yielding a final score ranging from 0 to 42, with higher scores indicating greater depressive symptoms. The primary outcome is the change in depression score from baseline to one-month follow-up between the intervention and control groups.
Anxiety
Change in anxiety score measured using the Depression Anxiety Stress Scale-21 (DASS-21) Anxiety subscale. The anxiety subscale consists of 7 items, each scored from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The summed subscale score is multiplied by 2, yielding a final score ranging from 0 to 42, with higher scores indicating greater anxiety symptoms. The primary outcome is the change in anxiety score from baseline to one-month follow-up between the intervention and control groups
Stress
Change in stress score measured using the Depression Anxiety Stress Scale-21 (DASS-21) Stress subscale. The stress subscale consists of 7 items, each scored from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The summed subscale score is multiplied by 2, yielding a final score ranging from 0 to 42, with higher scores indicating greater stress symptoms. The primary outcome is the change in stress score from baseline to one-month follow-up between the intervention and control groups.
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PakistanClick on the lead sponsor to view all of their trials.
Khyber Medical University Peshawar
Lead sponsor
Children Hospital Faisalabad
Collaborator
