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

20. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

77

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Zeenaf Aslam, RN, MSN,PHD*
  • Telefonnummer: +92 332 6613345
  • E-mail: zeenafch@gmail.com

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Creating Opportunities for Parent Empowerment (COPE), COPE Program Culturally Adapted, COPE
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Depression Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Khyber Medical University Peshawar

Samarbejdspartnere

Children Hospital Faisalabad

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2026

Primær færdiggørelse (Anslået)

30. marts 2027

Studieafslutning (Anslået)

25. maj 2027

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KMU/DIR/CTU/2026/07

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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