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

July 20, 2026 updated by: Khyber Medical University Peshawar

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Parents and primary caregivers of children with Autism Spectrum Disorder (ASD) frequently experience substantial psychological distress due to the long-term demands of caregiving, including elevated levels of stress, anxiety, and depression. In Pakistan, limited access to structured caregiver support programs, inadequate mental health services, financial constraints, and social stigma further increase caregiver burden. Although previous parent-mediated interventions conducted in Pakistan have demonstrated benefits for child developmental outcomes, few have specifically addressed the psychological wellbeing of caregivers. The Creating Opportunities for Parent Empowerment (COPE) program is an evidence-based, nurse-led psychoeducational intervention designed to improve parental coping, problem-solving, emotional regulation, and confidence through cognitive-behavioral strategies and structured education. This study seeks to culturally adapt the COPE intervention to ensure its relevance and acceptability within the Pakistani context.

The study will employ an exploratory sequential mixed-methods design. In the first phase, qualitative semi-structured interviews will be conducted with primary caregivers of children with ASD to identify their educational and psychosocial support needs. Findings from the thematic analysis will be used to culturally adapt the COPE intervention. In the second phase, a pilot randomized controlled feasibility trial will be conducted in which eligible caregivers will be randomly assigned to either an intervention group receiving the culturally adapted nurse-led COPE program in addition to routine hospital care or a control group receiving routine hospital care alone. The intervention will comprise four weekly sessions of approximately 45 minutes each, covering understanding ASD, cognitive restructuring, coping strategies, positive parenting, emotional support, and long-term family resilience.

Baseline and one-month follow-up assessments will be conducted using the Depression Anxiety Stress Scale-21 (DASS-21) to evaluate changes in depression, anxiety, and stress. In addition to clinical outcomes, the study will assess feasibility indicators including participant recruitment, retention, intervention adherence, acceptability, and implementation. Qualitative data will be analyzed using Braun and Clarke's thematic analysis approach, while quantitative data will be analyzed using IBM SPSS Statistics version 27 with appropriate descriptive and inferential statistical methods. The findings will provide essential evidence regarding the feasibility and acceptability of the culturally adapted nurse-led COPE intervention and will inform the planning of a fully powered randomized controlled trial aimed at improving the psychological wellbeing of caregivers of children with ASD in Pakistan.

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zeenaf Aslam, RN, MSN,PHD*
  • Phone Number: +92 332 6613345
  • Email: zeenafch@gmail.com

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Recruiting
        • Children Hospital Complex and Institute of Child Health
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Culturally Adapted Nurse-Led COPE Intervention
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.
Other Names:
  • Creating Opportunities for Parent Empowerment (COPE), COPE Program Culturally Adapted, COPE
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.
Other: Routine Hospital Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Score
Time Frame: Baseline and 1 month after completion of the intervention.
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.
Baseline and 1 month after completion of the intervention.
Anxiety
Time Frame: Baseline and 1 month after completion of the intervention.
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
Baseline and 1 month after completion of the intervention.
Stress
Time Frame: Baseline and 1 month after completion of the intervention.
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.
Baseline and 1 month after completion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Collaborators

Children Hospital Faisalabad

Investigators

  • Principal Investigator: Zeenaf Aslam, RN, MSN,PHD*, Institute of Nursing Sciences, Khyber Medical University Peshawar
  • Principal Investigator: Dr Dildar Muhammad, PhD, Institute of Nursing Sciences, Khyber Medical University Peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

May 25, 2027

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/DIR/CTU/2026/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in publications, including demographic characteristics, baseline data, intervention adherence, and outcome data (DASS-21 depression, anxiety, and stress scores), will be made available to qualified researchers. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal. All shared datasets will be fully de-identified to protect participant confidentiality and will comply with institutional ethical requirements and applicable data protection regulations.

IPD Sharing Time Frame

Data will become available within 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD Sharing Access Criteria

Qualified researchers whose proposed use of the data has been approved by the principal investigator and the Institutional Ethics Committee may access the de-identified data after submission of a methodologically sound research proposal and execution of a Data Sharing Agreement. Data will be used only for non-commercial scientific research consistent with the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Culturally Adapted Nurse-Led COPE Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe