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

20 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

77

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Zeenaf Aslam, RN, MSN,PHD*
  • Numéro de téléphone: +92 332 6613345
  • E-mail: zeenafch@gmail.com

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Recrutement
        • Children Hospital Complex and Institute of Child Health
        • Contact:
        • Contact:
          • Zeenaf Aslam, RN,MSN,PhD*
          • Numéro de téléphone: +92 332 6613345
          • E-mail: zeenafch@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Autres noms:
  • Creating Opportunities for Parent Empowerment (COPE), COPE Program Culturally Adapted, COPE
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Depression Score
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Khyber Medical University Peshawar

Collaborateurs

Children Hospital Faisalabad

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juillet 2026

Achèvement primaire (Estimé)

30 mars 2027

Achèvement de l'étude (Estimé)

25 mai 2027

Dates d'inscription aux études

Première soumission

20 juillet 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KMU/DIR/CTU/2026/07

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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