Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder (COPE-ASD)
20 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
77
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Zeenaf Aslam, RN, MSN,PHD*
- Numero di telefono: +92 332 6613345
- Email: zeenafch@gmail.com
Backup dei contatti dello studio
- Nome: Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- Numero di telefono: +923460113227
- Email: coordinator.ctu@kmu.edu.pk
Luoghi di studio
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 38000
- Reclutamento
- Children Hospital Complex and Institute of Child Health
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Contatto:
- Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- Numero di telefono: +923460113227
- Email: coordinator.ctu@kmu.edu.pk
-
Contatto:
- Zeenaf Aslam, RN,MSN,PhD*
- Numero di telefono: +92 332 6613345
- Email: zeenafch@gmail.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
|
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.
Altri nomi:
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Altro: 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.
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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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Depression Score
Lasso di tempo: 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.
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Baseline and 1 month after completion of the intervention.
|
|
Anxiety
Lasso di tempo: 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
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Baseline and 1 month after completion of the intervention.
|
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Stress
Lasso di tempo: 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.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Zeenaf Aslam, RN, MSN,PHD*, Institute of Nursing Sciences, Khyber Medical University Peshawar
- Investigatore principale: Dr Dildar Muhammad, PhD, Institute of Nursing Sciences, Khyber Medical University Peshawar
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Ronk 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.
- Zeidan 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.
- 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.
- Alibekova 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.
- Batool 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.
- Alghamdi 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 luglio 2026
Completamento primario (Stimato)
30 marzo 2027
Completamento dello studio (Stimato)
25 maggio 2027
Date di iscrizione allo studio
Primo inviato
20 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
20 luglio 2026
Primo Inserito (Effettivo)
23 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KMU/DIR/CTU/2026/07
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Data will become available within 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .