Autism Spectrum DisorderNCT05998382
The Effect of Parent Mediated Intervention Program on Children With ASD Exposed to Earthquake in Turkey in February 2023
A study testing Online group-based parent-mediated intervention program in people with Autism Spectrum Disorder and Earthquake, run by Sabri Hergüner at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 72 months
- Conditions the study is for
- Autism Spectrum Disorder, Earthquake, Behavior Problem of Childhood and Adolescence
- What is being tested?
- Online group-based parent-mediated intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Having a genetic disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Online group-based parent-mediated intervention program
- Keywords
- Autism spectrum disorder;, Social communication, Behavior Problem, Parent mediated intervention, earthquake, parental stress
- Medical subject headings
- Autism Spectrum Disorder, Communication, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online group-based parent-mediated intervention programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online group-based parent-mediated intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabri Hergüner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabri Hergüner, Herguner Therapy Private Clinic
- Investigators
- Sabri Hergüner, Assoc., Study director, Hergüner Therapy Privat Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998382
- Sponsor's protocol ID
- February2023earthquakeinTurkey
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05998382
- Acronym / sponsor ID
- February2023earthquakeinTurkey
- Keywords
- Autism spectrum disorder;, Social communication, Behavior Problem, Parent mediated intervention, earthquake, parental stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sabri HergünerUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Online group-based parent-mediated intervention programThere is only one group in the study. This group will participate in a 6-week online group-based parent-mediated intervention program. |
Who may qualify
- Ages
- 24 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Having a genetic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online group-based parent-mediated intervention programThe 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 | Behavioural | intervention group |
Primary outcome
change in autism symptom severity
Time frame: baseline and 6 weeks
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
Time frame: baseline and 6 weeks
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
Time frame: baseline and 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabri Hergüner, Assoc. study director
Hergüner Therapy Privat Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online group-based parent-mediated intervention program in people with Autism Spectrum Disorder and Earthquake, run by Sabri Hergüner at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in autism symptom severity (time frame: baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.