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)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Zeenaf Aslam, RN, MSN,PHD*
- 전화번호: +92 332 6613345
- 이메일: zeenafch@gmail.com
연구 연락처 백업
- 이름: Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- 전화번호: +923460113227
- 이메일: coordinator.ctu@kmu.edu.pk
연구 장소
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Punjab Province
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Faisalābad, Punjab Province, 파키스탄, 38000
- 모병
- Children Hospital Complex and Institute of Child Health
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연락하다:
- Dr Syed Muhammad Shabbir Ali Naqvi, PhD*
- 전화번호: +923460113227
- 이메일: coordinator.ctu@kmu.edu.pk
-
연락하다:
- Zeenaf Aslam, RN,MSN,PhD*
- 전화번호: +92 332 6613345
- 이메일: zeenafch@gmail.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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다른: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Depression Score
기간: Baseline and 1 month after completion of the intervention.
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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.
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Anxiety
기간: Baseline and 1 month after completion of the intervention.
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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
기간: 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.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Zeenaf Aslam, RN, MSN,PHD*, Institute of Nursing Sciences, Khyber Medical University Peshawar
- 수석 연구원: Dr Dildar Muhammad, PhD, Institute of Nursing Sciences, Khyber Medical University Peshawar
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- KMU/DIR/CTU/2026/07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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