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临床试验/NCT07027319
NCT07027319招募中不适用

The Effect of Triple P Training Applied to Parents of Children With Autism Spectrum Disorder on Children's Repetitive Behaviors and Parents' Mood and Burnout Levels

Özlem Teke1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
General mental state of parents of children with autism spectrum disorder

研究概览

简要总结

This project will be conducted in a private autism center in order to investigate the effects of Triple P training, which will be given to parents of children with Autism Spectrum Disorder, on the children's repetitive behaviors and the parents' burnout levels. The study is a randomized controlled trial and the study sample will consist of parents of children with Autism Spectrum Disorder. The children/parents included in the study sample will be numbered according to the order of arrival and 35 will be assigned to the intervention group and 35 will be assigned to the control group. During the randomization phase of the study, 70 children/parents with ASD will be randomly assigned to the intervention and control groups using Statistical Analysis Software. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS v26.0, IBM Corp., Armonk, NY, USA). Descriptive data will be analyzed as mean, frequency and percentage. The conformity of quantitative data to normal distribution will be evaluated using the Kolmogorov-Smirnov test. Paired sample t-test will be used to compare dependent groups with normal distribution, independent sample t-test will be used to compare independent groups with normal distribution. P value will be considered significant if it is less than 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
0 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Having a child diagnosed with Autism Spectrum Disorder between the ages of 0 and 12
  • •Being willing to participate in the study
  • •Parents who speak Turkish

排除标准

  • •Parents of children with Autism Spectrum Disorder who are 13 years of age or older
  • •Parents who do not speak Turkish

研究组 & 干预措施

Control group

No Intervention

This group will not be given any training other than the training they receive from the institution.

Parenting Education

Experimental

The intervention group will receive 8 sessions of Triple P (positive parenting training).

干预措施: Parenting Education (Other)

结局指标

主要结局

General mental state of parents of children with autism spectrum disorder

时间窗: T1: Baseline T2: 8 weeks T3: 3 months post-intervention

General Health Questionnaire-28-Will be used to evaluate the general mental state of parents of children with autism spectrum disorder. The scale, developed by Goldberg and utilizing the "GSA-type scoring" method, is used as a four-item scale in which the first two items are scored negatively and the last two items positively. Accordingly, items a and b are scored as "0" (zero), while items c and d are scored as "1" (one). The total score on the scale can range from a minimum of 0 to a maximum of 28. Individuals who score 4 or below are considered to be "normal" in terms of mental health, whereas those who score 5 or above are evaluated as being in the "at-risk group" regarding their mental health.

次要结局

未报告次要终点

研究者

发起方
Özlem Teke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Özlem Teke

MSc

Uskudar University

研究点 (1)

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