Clinical trial NCT05960981: Effects of Parent-Mediated Intervention on Restricted and Repetitive Behaviors in Children With ASD
Official title: Effects of Parent-Mediated Intervention on Restricted and Repetitive Behaviors in Children With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder;
Social communication
Restricted and repetitive behavior
Parent mediated intervention
Lead sponsor: Herguner Therapy Private Clinic
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 65
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in restricted repetitive behavior
timeFrame: baseline and 2.5 months
measure: Chance in social communication
timeFrame: baseline and 2.5 months
measure: change in emotion disregulation
timeFrame: baseline and 2.5 months
Secondary outcomes:
measure: Factors predicting change in restrictive repetitive behaviors
timeFrame: baseline and 2.5 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hergüner Therapy Private Clinic
Study officials:
affiliation: Hergüner Therapy Private Clinic
name: Sabri Hergüner, assoc.Prof.
role: STUDY_DIRECTOR
References: