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

NCT05960981 | Completed

• 1 other identifier: HergunerTheraPC
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism spectrum disorder;; Social communication; Restricted and repetitive behavior; Parent mediated intervention

Outcome Measures

Primary Outcomes (3)

• Change in restricted repetitive behavior

  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.

  baseline and 2.5 months

• Chance in social communication

  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.

  baseline and 2.5 months

• change in emotion disregulation

  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.

  baseline and 2.5 months

Secondary Outcomes (1)

• Factors predicting change in restrictive repetitive behaviors

  baseline and 2.5 months

Study Arms (1)

Intervention grup

EXPERIMENTAL

The work is one-armed. It consists of only those in the intervention group. After the study was announced, informed consent was obtained from those who agreed to participate in the study. Afterwards, the participants filled out the Demographic Data Form, Repetitive Behavior Scale-Revised (RBS-R), Social Communication Checklist-Revised (SCC-R), Child Behavior Checklist-Dysregulation Profile (CBCL-DP) forms before the intervention program started. When the 8-week online group-based parent mediated intervention program was over, they filled out formsRepetitive Behavior Scale-Revised (RBS-R), Social Communication Checklist-Revised (SCC-R), Child Behavior Checklist-Dysregulation Profile (CBCL-DP) again in the first week.

Behavioral: Online-delivered Group-based Parent Mediated Intervention for Young Children with ASD

Interventions

Online-delivered Group-based Parent Mediated Intervention for Young Children with ASD BEHAVIORAL

The program consists of eight weekly 2-hour group sessions, with each group consisting of 8 to 10 families. During the sessions, supervisors present the strategies to the parents and explain how to integrate them into their interactions with their children. Sample videos are shown to illustrate the strategies, and group discussions allow parents to discuss their application. In the second half of each session, the parents' recorded videos are watched, and supervisors provide feedback on whether the strategies were accurately implemented. At the end of each session, supervisors address any questions the parents may have.

Intervention grup

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sabri Hergüner: lead

Study Sites (1)

Hergüner Therapy Private Clinic

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Sabri Hergüner, assoc.Prof.

  Hergüner Therapy Private Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 27, 2023
• Study Start: March 12, 2022
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be shared 6 months after the study is published
• Access Criteria: Assoc.Prof. Dr. Sabri Hergüner will review the requests.

Locations

TU (1)