Feasibility of a Culturally Adapted Nurse-Led COPE Intervention for Caregivers of Children With Autism Spectrum Disorder (COPE-ASD)
20 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
77
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Zeenaf Aslam, RN, MSN,PHD*
- Номер телефона: +92 332 6613345
- Электронная почта: zeenafch@gmail.com
Учебное резервное копирование контактов
- Имя: Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- Номер телефона: +923460113227
- Электронная почта: coordinator.ctu@kmu.edu.pk
Места учебы
-
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Punjab Province
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Faisalābad, Punjab Province, Пакистан, 38000
- Рекрутинг
- Children Hospital Complex and Institute of Child Health
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Контакт:
- Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- Номер телефона: +923460113227
- Электронная почта: coordinator.ctu@kmu.edu.pk
-
Контакт:
- Zeenaf Aslam, RN,MSN,PhD*
- Номер телефона: +92 332 6613345
- Электронная почта: zeenafch@gmail.com
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
|
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Другой: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Depression Score
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Zeenaf Aslam, RN, MSN,PHD*, Institute of Nursing Sciences, Khyber Medical University Peshawar
- Главный следователь: Dr Dildar Muhammad, PhD, Institute of Nursing Sciences, Khyber Medical University Peshawar
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
15 июля 2026 г.
Первичное завершение (Оцененный)
30 марта 2027 г.
Завершение исследования (Оцененный)
25 мая 2027 г.
Даты регистрации исследования
Первый отправленный
20 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
20 июля 2026 г.
Первый опубликованный (Действительный)
23 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
23 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
20 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KMU/DIR/CTU/2026/07
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
Data will become available within 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Критерии совместного доступа к 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .