The Effect of Parent Mediated Intervention Program on Children With ASD Exposed to Earthquake in Turkey in February 2023

NCT05998382 | Unknown

• 1 other identifier: February2023earthquakeinTurkey
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Earthquake; Behavior Problem of Childhood and Adolescence

Keywords

Autism spectrum disorder;; Social communication; Behavior Problem; Parent mediated intervention; earthquake; parental stress

Outcome Measures

Primary Outcomes (3)

• change in autism symptom severity

  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

  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

  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

Study Arms (1)

intervention group

EXPERIMENTAL

There is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program.

Behavioral: Online group-based parent-mediated intervention program

Interventions

Online group-based parent-mediated intervention program BEHAVIORAL

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

intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Having a genetic disease

Sponsors & Collaborators

• Sabri Hergüner: lead

Study Sites (1)

Hergüner Therapy Private Clinic

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication; Mental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Behavior

Study Officials

• Sabri Hergüner, Assoc.

  Hergüner Therapy Privat Clinic

  STUDY DIRECTOR

Central Study Contacts

Sabri Hergüner, Assoc.

CONTACT

+905337428150; sabriherguner@gmail.com

Sümeyra Fırat, specialist

CONTACT

+905449765255; drsumeyrafirat@gmail.com

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

Model Details: It will be realized with the participation of 24-72 months old children with autism spectrum disorder and their parents who were exposed to earthquake. The program will be announced via social media. After the applicants are evaluated, the families who will participate in the program will be given detailed information about the study and informed consent will be obtained. Before the training begins, families will be asked to fill out the Sociodemographic Data Form, Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist. Families will participate in the training program that will last 6 weeks. At the end of the 6th week, families will be asked to fill in the Social Communication Checklist-Revised-Preschool Turkish Version, Depression Anxiety Stress Scale, ½-5 years old Child Behavior Checklist Scale again. The change from time t1-baseline to time t2-6 weeks later was calculated by arithmetic method.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

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 publish
• Access Criteria: Assoc. Prof. Dr. Sabri Hergüner will review the requests.

Locations

TU (1)