Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder

Sponsor
Khyber Medical University Peshawar
Study ID
NCT07722949
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Culturally Adapted Nurse-Led COPE Intervention — BEHAVIORAL
    The 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
    Participants 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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Mar 30, 2027
Completion
May 25, 2027

Study Design

Enrollment
77 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Depression Score [ Time Frame: Baseline and 1 month after completion of the intervention. ]

Central Contacts

Find similar trials

Nationwide
Autism spectrum disorder trialsDepression trialsPediatrics trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies