- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05998382
2023년 2월 터키 지진에 노출된 자폐아동에 대한 부모중재 개입 프로그램의 효과
2023년 2월 터키 지진에 노출된 자폐스펙트럼장애아동의 자폐증 증상, 행동문제 및 부모의 스트레스 수준에 대한 부모중재 개입 프로그램의 효과 원문보기 KCI 원문보기 인용
After devastating natural events such as earthquakes, individuals with special needs experience much more difficulties. There is a limited number of studies investigating the impact of disasters on individuals with autism. Studies show that resilience and recovery of pre-disaster functioning in young people with autism largely depends on their immediate inclusion in routine, intensive rehabilitation programs and the stabilization of daily life routines as much as possible. Children with autism had to interrupt their education due to many reasons such as the destruction of special education centers due to the earthquake and the temporary or permanent relocation of families to different cities. The fact that individuals with autism stayed away from education after the earthquake caused parents' stress and anxiety levels to increase. Parent involvement, a standard intervention practice in ASD, shows that teaching intervention strategies to parents can improve children's outcomes and increase parental effectiveness. Researchers aim in this study is to investigate the effect of the online group-based parent-mediated intervention program on autism symptoms, the effect on behavioral problems and the effect on parental mental health of children with autism spectrum disorder whose education life was interrupted 8 months after the earthquake, who had major changes in their lives (such as loss of relatives, loss of health, work, home, anxiety, having to change cities ...).
Online group-based intervention program ist designed to improve the interaction, play, speech and learning skills of children with autism symptoms, taking into account the earthquake conditions.
연구 개요
상태
상세 설명
Earthquakes are considered to be destructive, uncontrollable natural disasters that cause the most migration and threaten life the most. After the earthquake that occurred in L'Aquila, the capital of Abruzzo region of Italy on April 2009, children and adolescents with autism who were and were not exposed to the earthquake were followed up for 1 year in terms of adaptation skills. It was observed that adaptive skills (communication, daily living skills, socialization and motor skills) were clinically and statistically decreased one month after the earthquake in individuals with autism exposed to the earthquake. Compared to the unexposed group, adaptive skills were also found to be significantly lower. It was found that adaptation skills were 30% lower in the 6th month of the earthquake compared to the beginning and 15% lower in the 1st year.
Studies show that the recovery of resilience and pre-disaster functions in young people with autism largely depends on their immediate inclusion in routine, intensive rehabilitation programs and fixation of daily life routines as much as possible. However, after the February 06, 2023 Kahramanmaraş earthquake, many rehabilitation centers where individuals with autism received special education support were destroyed. This has made it difficult for individuals with autism to access special education support. What we know about the impact of trauma in children is that the response to traumatic events is mediated by caregivers and important people in the child's life. The fact that individuals with autism stayed away from education after the earthquake may cause parents' stress and anxiety levels to increase and their ability to cope with trauma to be negatively affected, which may naturally cause individuals with autism to be more affected by trauma.
Parental involvement in intervention in Autism Spectrum Disorder (ASD) is a standard intervention practice and research shows that teaching parents intervention strategies can improve children's outcomes and increase parental effectiveness. Parent-mediated interventions that are naturalistic, developmental and behavioral are effective in improving social and communication skills for children with ASD.
Learning that their child has ASD causes serious stress on families from the moment the diagnosis is made. High levels of parental stress have been shown to negatively affect the effectiveness of parent-mediated interventions (possibly due to interference with parental learning). Therefore, it is important to determine intervention strategies by considering parental stress in parent-mediated intervention programs.
One of the challenges for parents and children with ASD is the limited access to education, the costly nature of the education process, and sometimes the inability to make the necessary arrangements for the family to benefit from education (such as caring for other children, arranging work schedules). Online group-based trainings make it easier for families to overcome these challenges. They can access education from their own homes, it is much more cost-effective and it can be easier to make environmental arrangements. Group-based training can also help families to support and learn from each other.
The parent training program to be implemented is an online group-based intervention program implemented by parents to improve the interaction, play, speech and learning skills of children with autism symptoms. Through this program, families will be able to overcome the time, place and economic difficulties that prevent them from accessing education, and since it is a program implemented by parents, they will have the opportunity to apply it to children in a natural environment throughout the day. It will also partially prevent families from being away from education due to the destruction of education centers, relocation of educators to different cities or inaccessibility due to reasons such as death. There are a limited number of studies on the processes of readjustment of children with Autism Spectrum Disorder to daily life after natural disasters such as earthquakes that cause serious losses. There is no study on this theme conducted in Turkey.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Ankara, 터키 (Türkiye)
- Hergüner Therapy Private Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The diagnosis of autism must be made by a specialist
- Being in the age range of 24-72 months
- Living in one of the 10 provinces where the earthquake was felt intensely during the earthquake
Exclusion Criteria:
- Having a genetic disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: intervention group
There is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program. |
The program is an online group-based parent-mediated intervention program implemented in 2 sessions of 2 hours once a week for 6 weeks. In the first part of the weekly sessions, the topic of that week is explained to the parents. In the second part, videos recorded by the parents are watched and feedback is given to the parents. At the end of the session, written materials about that week's practices and homework are sent to the parents |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
change in autism symptom severity
기간: baseline and 6 weeks
|
Researcher examined the effect of intervention on autism symptom severity by using the change in Social Communication Checklist-Revised (SCC-R) scores. After the intervention program, whether there were significant changes in the total scores and subscales of Social Communication Checklist-Revised (SCC-R) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.Social Communication Checklist-Revised (SCC-R): The SCC-R is a 70-item checklist.They are summed for domain scores and a Total Score. Respondents indicate whether a child uses each skill, "Rarely/Not Yet (1)," "Sometimes, but not consistently (2)," or "Usually, at least 75% of the time (3)". The total score would then be between 70 and 215. An increase in the Total Score means that social communication skills have increased. |
baseline and 6 weeks
|
|
change in behavior problems
기간: baseline and 6 weeks
|
Researcher examined the effect of intervention on behaviour problems by using the change in 1/2-5 age Child Behavior Checklist- 1/2-5 CBCL) scores. After the intervention program, whether there were significant changes in the total scores and subscales of 1/2-5 Child Behavior Checklist was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions. 1/2-5 Child Behavior Checklist: CBCL 1.5-5 is a 99-item. The item is marked as 0 if the child does not have it, 1 if it is sometimes or somewhat true for the child, and 2 if it is very true or often true. An increase in total score means that behaviour problems is exacerbated. |
baseline and 6 weeks
|
|
change in parental stress level
기간: baseline and 6 weeks
|
It was measured by the change in the Depression Anxiety Stress Scale After the intervention program, whether there were significant changes in the total scores and subscales of Depression Anxiety Stress Scale (DASS-21) was determined by the paired t test if it met the normal distribution conditions, and the Wilcoxon test if it did not meet the normal distribution conditions.DASS-21 contains 21 items and has 3 subscales: depression, stress and anxiety. It is a Likert-type scale. As the total score increases, the severity of depression, stress and anxiety increases. |
baseline and 6 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Sabri Hergüner, Assoc., Hergüner Therapy Privat Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- February2023earthquakeinTurkey
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
all collected IPD, all IPD that underlie results in a publication
IPD 공유 기간
Data can be shared 6 months after the study is publish
IPD 공유 액세스 기준
Assoc. Prof. Dr. Sabri Hergüner will review the requests.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .