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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Online group-based parent-mediated intervention program
Sponsored by
Sabri Hergüner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder;, Social communication, Behavior Problem, Parent mediated intervention, earthquake, parental stress

Eligibility Criteria

24 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Having a genetic disease

Sites / Locations

  • Hergüner Therapy Private Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 31, 2023
Sponsor
Sabri Hergüner
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1. Study Identification

Unique Protocol Identification Number
NCT05998382
Brief Title
The Effect of Parent Mediated Intervention Program on Children With ASD Exposed to Earthquake in Turkey in February 2023
Official Title
The Effect of Parent-Mediated Intervention Program on Children's Autism Symptoms, Behavioral Problems and Parents' Stress Level in Children With Autism Spectrum Disorder Exposed to Earthquake in Turkey in February 2023
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sabri Hergüner

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Earthquakes are considered to be destructive, uncontrollable natural disasters that cause the most migration and threaten life the most. After the earthquake that occurred in L'Aquila, the capital of Abruzzo region of Italy on April 2009, children and adolescents with autism who were and were not exposed to the earthquake were followed up for 1 year in terms of adaptation skills. It was observed that adaptive skills (communication, daily living skills, socialization and motor skills) were clinically and statistically decreased one month after the earthquake in individuals with autism exposed to the earthquake. Compared to the unexposed group, adaptive skills were also found to be significantly lower. It was found that adaptation skills were 30% lower in the 6th month of the earthquake compared to the beginning and 15% lower in the 1st year. Studies show that the recovery of resilience and pre-disaster functions in young people with autism largely depends on their immediate inclusion in routine, intensive rehabilitation programs and fixation of daily life routines as much as possible. However, after the February 06, 2023 Kahramanmaraş earthquake, many rehabilitation centers where individuals with autism received special education support were destroyed. This has made it difficult for individuals with autism to access special education support. What we know about the impact of trauma in children is that the response to traumatic events is mediated by caregivers and important people in the child's life. The fact that individuals with autism stayed away from education after the earthquake may cause parents' stress and anxiety levels to increase and their ability to cope with trauma to be negatively affected, which may naturally cause individuals with autism to be more affected by trauma. Parental involvement in intervention in Autism Spectrum Disorder (ASD) is a standard intervention practice and research shows that teaching parents intervention strategies can improve children's outcomes and increase parental effectiveness. Parent-mediated interventions that are naturalistic, developmental and behavioral are effective in improving social and communication skills for children with ASD. Learning that their child has ASD causes serious stress on families from the moment the diagnosis is made. High levels of parental stress have been shown to negatively affect the effectiveness of parent-mediated interventions (possibly due to interference with parental learning). Therefore, it is important to determine intervention strategies by considering parental stress in parent-mediated intervention programs. One of the challenges for parents and children with ASD is the limited access to education, the costly nature of the education process, and sometimes the inability to make the necessary arrangements for the family to benefit from education (such as caring for other children, arranging work schedules). Online group-based trainings make it easier for families to overcome these challenges. They can access education from their own homes, it is much more cost-effective and it can be easier to make environmental arrangements. Group-based training can also help families to support and learn from each other. The parent training program to be implemented is an online group-based intervention program implemented by parents to improve the interaction, play, speech and learning skills of children with autism symptoms. Through this program, families will be able to overcome the time, place and economic difficulties that prevent them from accessing education, and since it is a program implemented by parents, they will have the opportunity to apply it to children in a natural environment throughout the day. It will also partially prevent families from being away from education due to the destruction of education centers, relocation of educators to different cities or inaccessibility due to reasons such as death. There are a limited number of studies on the processes of readjustment of children with Autism Spectrum Disorder to daily life after natural disasters such as earthquakes that cause serious losses. There is no study on this theme conducted in Turkey.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Earthquake, Behavior Problem of Childhood and Adolescence
Keywords
Autism spectrum disorder;, Social communication, Behavior Problem, Parent mediated intervention, earthquake, parental stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
There is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program.
Intervention Type
Behavioral
Intervention Name(s)
Online group-based parent-mediated intervention program
Intervention Description
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
Primary Outcome Measure Information:
Title
change in autism symptom severity
Description
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.
Time Frame
baseline and 6 weeks
Title
change in behavior problems
Description
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.
Time Frame
baseline and 6 weeks
Title
change in parental stress level
Description
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.
Time Frame
baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Having a genetic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabri Hergüner, Assoc.
Phone
+905337428150
Email
sabriherguner@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sümeyra Fırat, specialist
Phone
+905449765255
Email
drsumeyrafirat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabri Hergüner, Assoc.
Organizational Affiliation
Hergüner Therapy Privat Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Hergüner Therapy Private Clinic
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
Data can be shared 6 months after the study is publish
IPD Sharing Access Criteria
Assoc. Prof. Dr. Sabri Hergüner will review the requests.

Learn more about this trial

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

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