Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder
COPE-ASD
Feasibility of Culturally Adapted, Nurse-Led COPE Intervention on Psychological Wellbeing of Primary Caregivers of Child With Autism Spectrum Disorder (CASD)
1 other identifier
interventional
77
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2026
CompletedFirst Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
July 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2027
July 23, 2026
July 1, 2026
9 months
July 20, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline and 1 month after completion of the intervention.
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
Baseline and 1 month after completion of the intervention.
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.
Baseline and 1 month after completion of the intervention.
Study Arms (2)
Culturally Adapted Nurse-Led COPE Intervention
EXPERIMENTALParticipants 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.
Routine Care
OTHERParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khyber Medical University Peshawarlead
- Children Hospital Faisalabadcollaborator
Study Sites (1)
Children Hospital Complex and Institute of Child Health
Faisalābad, Punjab Province, 38000, Pakistan
Related Publications (6)
Rahman A, Divan G, Hamdani SU, Vajaratkar V, Taylor C, Leadbitter K, Aldred C, Minhas A, Cardozo P, Emsley R, Patel V, Green J. Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): a randomised controlled trial. Lancet Psychiatry. 2016 Feb;3(2):128-36. doi: 10.1016/S2215-0366(15)00388-0. Epub 2015 Dec 17.
PMID: 26704571BACKGROUNDRonk FR, Korman JR, Hooke GR, Page AC. Assessing clinical significance of treatment outcomes using the DASS-21. Psychol Assess. 2013 Dec;25(4):1103-10. doi: 10.1037/a0033100. Epub 2013 Jun 3.
PMID: 23730826BACKGROUNDAlibekova R, Kai Chan C, Crape B, Kadyrzhanuly K, Gusmanov A, An S, Bulekbayeva S, Akhmetzhanova Z, Ainabekova A, Yerubayev Z, Yessimkulova F, Bekisheva A, Ospanova Z, Rakhimova M. Stress, anxiety and depression in parents of children with autism spectrum disorders in Kazakhstan: prevalence and associated factors. Glob Ment Health (Camb). 2022 Oct 11;9:472-482. doi: 10.1017/gmh.2022.51. eCollection 2022.
PMID: 36618742BACKGROUNDZeidan J, Fombonne E, Scorah J, Ibrahim A, Durkin MS, Saxena S, Yusuf A, Shih A, Elsabbagh M. Global prevalence of autism: A systematic review update. Autism Res. 2022 May;15(5):778-790. doi: 10.1002/aur.2696. Epub 2022 Mar 3.
PMID: 35238171BACKGROUNDBatool SS, Khurshid S. Factors Associated with Stress Among Parents of Children with Autism. J Coll Physicians Surg Pak. 2015 Oct;25(10):752-6. doi: 10.2015/JCPSP.752756.
PMID: 26454393BACKGROUNDAlghamdi K, Alahmadi S, Sayedahmad A, Mosleh H. Psychological Well-Being of Mothers of Children With Autism in Saudi Arabia. Cureus. 2022 Mar 18;14(3):e23284. doi: 10.7759/cureus.23284. eCollection 2022 Mar.
PMID: 35449665BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label pilot feasibility randomized controlled trial. Due to the nature of the behavioral intervention, participants, care providers, and investigators will be aware of treatment allocation. Outcome assessments will be based on participant-completed questionnaires.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
July 23, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
May 25, 2027
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available within 6 months after publication of the primary study results and will remain available for 5 years thereafter.
- 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.
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.