跳至主要内容
临床试验/NCT05960981
NCT05960981已完成不适用

Effects of Parent-Mediated Intervention on Restricted and Repetitive Behaviors in Children With ASD

Sabri Hergüner1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Change in restricted repetitive behavior

研究概览

简要总结

Our primary aim in the study is to investigate the effect of an online group-based 8-week parent-mediated intervention program targeting social communication on restrictive repetitive behaviors. Our second aim is to investigate the factors affecting the change in restrictive repetitive behavior. Our hypotheses are that after completing the 8-week online group-based parent-mediated intervention program, the participants' social interaction skills will increase, their restrictive repetitive behaviors will decrease, and their emotion regulation problems will decrease.

详细描述

Repetitive motor movements, preoccupations with objects, strict adherence to routines and rituals, and a resistance to change are all examples of restricted repetitive behaviors (RRBs). These behaviors are not exclusive to autism spectrum disorder (ASD) and can also be observed in children with intellectual disabilities and typically developing children. However, children with ASD tend to exhibit RRBs more frequently, severely, and intensely.

Studies have shown that as typically developing children improve their language and social interaction skills, the frequency of RRBs tends to decrease. On the other hand, research involving children with ASD has demonstrated that RRBs are associated with a decline in social interaction abilities. However, there are also studies suggesting that RRBs are unrelated to social communication skills. Anxiety has been found to be connected to RRBs in children with ASD, and one study even identified emotion regulation problems as the strongest predictor of RRBs.

RRBs can consume a significant amount of time, limit opportunities for social interactions, and hinder the acquisition of new skills in children. They can also have a negative impact on family functioning and well-being. Parents often find managing RRBs to be the most stressful and challenging aspect of dealing with ASD. Unfortunately, research on restricted repetitive behaviors is limited, with a primary focus on pharmacological treatments and behavioral interventions that predominantly utilize single-case designs. Various strategies have been employed with some success to address RRBs, such as blocking, interrupting, and redirecting for lower-order RRBs, as well as cognitive behavioral therapy and differential reinforcement strategies for higher-order RRBs. However, managing RRBs remains a significant challenge for parents, as the available interventions have limited effectiveness.

RRBs create considerable difficulties for both children with ASD and their families. In this study, we aim to investigate the impact of an 8-week online group-based parent-mediated intervention on restricted repetitive behaviors. Additionally, we will explore the factors that influence the improvement of these behaviors. This research endeavor is expected to provide valuable insights and contribute to the existing knowledge on effectively managing RRBs. The findings have the potential to benefit both professionals and parents by equipping them with enhanced coping strategies. Furthermore, this study will contribute to the expansion of scientific literature regarding the effects of parent-mediated interventions on addressing RRBs, thereby advancing our understanding in this area.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
24 Months 至 72 Months(Child)
性别
All
接受健康志愿者

入选标准

  • the child had a confirmed clinical diagnosis of ASD,
  • the child was aged between 2 and 6 years,
  • the parents were able to speak and read Turkish sufficiently,
  • parents agreed not to start any other new intensive interventions during the study,
  • same parent could attend each session

排除标准

  • a medical condition that impacted development (e.g., Fragile X, Down syndrome, tuberous sclerosis
  • enrolment in any other parent-mediated intervention(s) during the study

结局指标

主要结局

Change in restricted repetitive behavior

时间窗: baseline and 2.5 months

We examined the effect of intervention on RRBs by using the change in Repetitive Behavior Scale-Revised (RBS-R) scores. After the intervention program, whether there were significant changes in the total scores and subscales of Repetitive Behavior Scale-Revised (RBS-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.Repetitive Behavior Scale-Revised (RBS-R): The RBS-R is a 43-item parent rating scale. All items are rated on a four-point Likert scale of severity; the higher the scores, the more severe the conditions (i.e., 0 = behavior does not occur, 1 = behavior occurs and is a mild problem, 2 = behavior occurs and is a moderate problem, 3 = behavior occurs and is a severe problem). The scale can be scored between 0-129.

Chance in social communication

时间窗: baseline and 2.5 months

We examined the effect of intervention on social cominication 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.

change in emotion disregulation

时间窗: baseline and 2.5 months

We examined the effect of intervention on emotion disregulation by using the change in Child Behavior Checklist-Dysregulation Profile(CBCL-DP) scores. After the intervention program, whether there were significant changes in the total scores and subscales of Child Behavior Checklist-Dysregulation Profile (CBCL-DP) 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.Child Behavior Checklist-Dysregulation Profile (CBCL-DP): CBCL 1.5-5 is a 99-item. The CBCL-DP score is computed by the sum of the Attention, Aggression, and Anxious/Depressed subscales of the CBCL 1.5-5. 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 emotional dysregulation is exacerbated.

次要结局

  • Factors predicting change in restrictive repetitive behaviors(baseline and 2.5 months)

研究者

发起方
Sabri Hergüner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sabri Hergüner

associate professor

Herguner Therapy Private Clinic

研究点 (1)

Loading locations...

相似试验

Effects of Parent-Mediated Intervention on... | 临床试验