Autism Spectrum DisorderOYNA-1NCT07742774
Online Parent-Mediated Intervention for Preschool Autistic Children
A study testing OYNA-1: Online Group-Based Parent-Mediated Intervention in people with Autism Spectrum Disorder, run by Herguner Therapy Private Clinic at 1 site in Turkey (Türkiye).
Trial summary
Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and interaction, accompanied by restricted and repetitive patterns of behavior. Parent-mediated interventions are recommended as an evidence-based approach for promoting early developmental outcomes by enabling parents to… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- OYNA-1: Online Group-Based Parent-Mediated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2022to 13 Aug 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 5 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- ASD diagnosis confirmed by an experienced child and adolescent psychiatrist.
- At least one parent or primary caregiver willing to participate in all intervention sessions.
- The same parent or primary caregiver available to participate throughout the study.
- Parents willing to complete all study assessments.
- Families agreeing not to initiate another structured parent-mediated intervention during the study period.
- Written informed consent provided by the participating parent or legal guardian.
Who cannot join
- Presence of genetic, neurological, or significant sensory disorders (e.g., hearing impairment) that could substantially affect child development.
- Participation in another structured parent-mediated intervention during the study period.
- -Inability of the participating parent to attend the intervention sessions or complete the study assessments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sabri Hergüner Child and Adolescent Psychiatry Private Practice
Çankaya, Ankara, 06530
About this study
Official title: Effectiveness of an Online Group-Based Parent-Mediated Intervention for Preschool Autistic Children: A Randomized Controlled Trial
Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and interaction, accompanied by restricted and repetitive patterns of behavior. Parent-mediated interventions are recommended as an evidence-based approach for promoting early developmental outcomes by enabling parents to implement intervention strategies during everyday interactions with their children.
The purpose of this randomized controlled trial was to evaluate the effectiveness of an eight-week online group-based parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles for preschool autistic children compared with a waitlist control group. Families were randomly assigned to either the intervention group or the waitlist control group. Parents in the intervention group participated in weekly online group sessions that included psychoeducation, therapist coaching, video-based feedback, and structured home practice, whereas families in the waitlist control group continued their usual educational services during the study period. Participants in the intervention group were additionally assessed eight weeks after completion of the intervention to evaluate the maintenance of treatment effects.
The primary outcome was the between-group difference in children's social communication skills, measured using the Social Communication Checklist-Revised (SCC-R), from baseline to immediately after the intervention. Secondary outcomes included between-group differences in parental psychological distress measured by the Depression Anxiety Stress Scales-21 (DASS-21) and parental broad autism phenotype characteristics measured by the Broad Autism Phenotype Questionnaire (BAPQ), as well as the maintenance of treatment effects in the intervention group at the eight-week follow-up. The study also examined demographic and clinical factors associated with improvements in children's social communication skills following the intervention.
Read the detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction together with restricted and repetitive patterns of behavior. Early intervention is associated with improved developmental outcomes, and parent-mediated interventions are recommended because they enable parents to implement evidence-based strategies within naturally occurring daily routines, thereby increasing children's opportunities for learning throughout the day.
Naturalistic Developmental Behavioral Interventions (NDBIs) integrate principles of developmental science and applied behavior analysis and emphasize responsive parenting, child-led interactions, and learning opportunities embedded in everyday activities. Although parent-mediated NDBI programs have demonstrated beneficial effects on children's developmental outcomes, access to these interventions remains limited for many families because of geographical, financial, and service-related barriers. Delivering parent-mediated interventions through online platforms may increase accessibility while preserving the essential components of parent coaching.
This randomized controlled trial evaluated the effectiveness of an eight-week online group-based parent-mediated intervention (OYNA-1), based on NDBI principles, for preschool autistic children. Families were randomly assigned to either the intervention group or a waitlist control group. Parents in the intervention group participated in weekly online group sessions involving psychoeducation, therapist coaching, video-based feedback, and structured home practice, whereas families in the waitlist control group continued their usual educational services during the study period.
The primary objective was to compare changes in children's social communication skills between the intervention and waitlist control groups using the Social Communication Checklist-Revised (SCC-R). Secondary objectives were to compare changes in parental psychological distress, assessed with the Depression Anxiety Stress Scales-21 (DASS-21), and parental broad autism phenotype characteristics, assessed with the Broad Autism Phenotype Questionnaire (BAPQ), between groups. Participants in the intervention group also completed an additional assessment eight weeks after the intervention to evaluate the maintenance of treatment effects. Finally, demographic and clinical variables selected a priori based on clinical relevance were examined as potential predictors of improvements in children's social communication following the intervention.
- Conditions
- Autism Spectrum Disorder
- Being tested
- OYNA-1: Online Group-Based Parent-Mediated Intervention
- Keywords
- Autism Spectrum Disorder, Parent-Mediated Intervention, Naturalistic Developmental Behavioral Intervention, NDBI, Online Intervention, Preschool Children, Early Intervention, Social Communication, Randomized Controlled Trial, Parent Training
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OYNA-1: Online Group-Based Parent-Mediated InterventionBehavioural
An eight-week online parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles. The program consisted of weekly online group sessions including psychoeducation, therapist coaching, video-based feedback, structured home practice, and individualized feedback. Parents were encouraged to implement the intervention strategies during everyday interactions with their children while continuing their usual educational services.
| Study group | Role | What they receive |
|---|---|---|
| Online Parent-Mediated Intervention | Experimental | Participants received an eight-week online parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles. The program included weekly group sessions consisting of psychoeducation, therapist coaching, video-based feedback, structured home practice, and individualized guidance. Participants continued to receive their usual educational services during the study period. Receives: Behavioral: OYNA-1: Online Group-Based Parent-Mediated Intervention |
| The control group | No intervention | Participants remained on a waitlist during the study period and continued their usual educational services without receiving the online parent-mediated intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-Group Difference in Social Communication Checklist-Revised Total Score After the 8-Week Intervention
Children's social communication skills were assessed using the Social Communication Checklist-Revised (SCC-R), a 70-item parent-report measure for children aged 18 months to 6 years. The scale includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation and Play. Items are rated from 1 to 3, and total scores range from 70 to 210, with higher scores indicating better social communication skills. The primary analysis compared post-intervention SCC-R total scores between the intervention and waitlist control groups while adjusting for baseline SCC-R total scores. Secondary analyses also compared the four SCC-R subscale scores between groups.
Measured: Baseline and immediately after the 8-week intervention
Secondary outcomes (6)
Between-Group Difference in Depression Anxiety Stress Scales-21 Total and Subscale Scores After the 8-Week Intervention
Parental psychological distress was assessed using the Depression Anxiety Stress Scales-21 (DASS-21), a 21-item self-report questionnaire comprising three 7-item subscales: Depression, Anxiety, and Stress. Items are rated on a 4-point scale from 0 to 3. Higher total and subscale scores indicate greater psychological distress. Post-intervention DASS-21 total, Depression, Anxiety, and Stress scores were compared between the intervention and waitlist control groups while adjusting for the corresponding baseline scores.
Measured: Baseline and immediately after the 8-week intervention.
Between-Group Difference in Broad Autism Phenotype Questionnaire Total and Subscale Scores After the 8-Week Intervention
Parental broad autism phenotype characteristics were assessed using the Broad Autism Phenotype Questionnaire (BAPQ), a 36-item self-report questionnaire comprising three domains: Aloof Personality, Rigid Personality, and Pragmatic Language Difficulties. Items are rated on a 6-point scale, with higher total and subscale scores indicating greater expression of broad autism phenotype characteristics. Post-intervention BAPQ total, Aloof Personality, Rigid Personality, and Pragmatic Language scores were compared between the intervention and waitlist control groups while adjusting for the corresponding baseline scores.
Measured: Baseline and immediately after the 8-week intervention.
Change in Social Communication Checklist-Revised Scores Through the 8-Week Follow-up in the Intervention Group
The maintenance of changes in children's social communication was evaluated using the Social Communication Checklist-Revised (SCC-R), a 70-item parent-report measure for children aged 18 months to 6 years. The scale includes Social Engagement, Expressive Communication, Receptive Communication, and Imitation and Play domains. Items are rated from 1 to 3, and total scores range from 70 to 210, with higher scores indicating better social communication skills. Total and subscale scores were assessed at baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion in the intervention group.
Measured: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Change in Depression Anxiety Stress Scales-21 Scores Through the 8-Week Follow-up in the Intervention Group
The maintenance of changes in parental psychological distress was evaluated using the Depression Anxiety Stress Scales-21 (DASS-21), a 21-item self-report questionnaire comprising Depression, Anxiety, and Stress subscales. Items are rated from 0 to 3, with higher total and subscale scores indicating greater psychological distress. Total and subscale scores were assessed at baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion in the intervention group.
Measured: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Change in Broad Autism Phenotype Questionnaire Scores Through the 8-Week Follow-up in the Intervention Group
The maintenance of changes in parental broad autism phenotype characteristics was evaluated using the Broad Autism Phenotype Questionnaire (BAPQ), a 36-item self-report questionnaire comprising Aloof Personality, Rigid Personality, and Pragmatic Language Difficulties domains. Items are rated on a 6-point scale, with higher total and subscale scores indicating greater expression of broad autism phenotype characteristics. Total and subscale scores were assessed at baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion in the intervention group.
Measured: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Demographic and Clinical Factors Associated With Change in SCC-R Total Score
Multivariable regression analysis was used to examine prespecified demographic and clinical factors associated with change in the SCC-R total score from baseline to immediately after the intervention. The dependent variable was the SCC-R change score, calculated as the post-intervention total score minus the baseline total score. Positive change scores indicated greater improvement in children's social communication skills. Candidate predictors were selected a priori based on clinical relevance.
Measured: Baseline and immediately after the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start27 Dec 2022
- Primary completion10 Jun 2023
- Study completion13 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a parallel-group design to either an online NDBI-based parent-mediated intervention or a waitlist control group. Outcome assessments were conducted at baseline and immediately after the intervention in both groups. Participants in the intervention group also completed a two-month follow-up assessment to evaluate the maintenance of treatment effects.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herguner Therapy Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Hergüner, Herguner Therapy Private Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742774
- Sponsor's protocol ID
- OYNA1-RCT-2026-07
- Acronym
- OYNA-1
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent and ethics approval did not include provisions for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Group-Based Parent-Mediated Intervention for Preschool Autistic Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07742774
- Acronym / sponsor ID
- OYNA-1 / OYNA1-RCT-2026-07
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Parent-Mediated Intervention, Naturalistic Developmental Behavioral Intervention, NDBI, Online Intervention, Preschool Children, Early Intervention, Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Herguner Therapy Private ClinicUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 3 Aug 2026 (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.
Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and interaction, accompanied by restricted and repetitive patterns of behavior. Parent-mediated interventions are recommended as an evidence-based approach for promoting early developmental outcomes by enabling parents to implement intervention strategies during everyday interactions with their children.
The purpose of this randomized controlled trial was to evaluate the effectiveness of an eight-week online group-based parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles for preschool autistic children compared with a waitlist control group. Families were randomly assigned to either the intervention group or the waitlist control group. Parents in the intervention group participated in weekly online group sessions that included psychoeducation, therapist coaching, video-based feedback, and structured home practice, whereas families in the waitlist control group continued their usual educational services during the study period. Participants in the intervention group were additionally assessed eight weeks after completion of the intervention to evaluate the maintenance of treatment effects.
The primary outcome was the between-group difference in children's social communication skills, measured using the Social Communication Checklist-Revised (SCC-R), from baseline to immediately after the intervention. Secondary outcomes included between-group differences in parental psychological distress measured by the Depression Anxiety Stress Scales-21 (DASS-21) and parental broad autism phenotype characteristics measured by the Broad Autism Phenotype Questionnaire (BAPQ), as well as the maintenance of treatment effects in the intervention group at the eight-week follow-up. The study also examined demographic and clinical factors associated with improvements in children's social communication skills following the intervention.
Detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction together with restricted and repetitive patterns of behavior. Early intervention is associated with improved developmental outcomes, and parent-mediated interventions are recommended because they enable parents to implement evidence-based strategies within naturally occurring daily routines, thereby increasing children's opportunities for learning throughout the day.
Naturalistic Developmental Behavioral Interventions (NDBIs) integrate principles of developmental science and applied behavior analysis and emphasize responsive parenting, child-led interactions, and learning opportunities embedded in everyday activities. Although parent-mediated NDBI programs have demonstrated beneficial effects on children's developmental outcomes, access to these interventions remains limited for many families because of geographical, financial, and service-related barriers. Delivering parent-mediated interventions through online platforms may increase accessibility while preserving the essential components of parent coaching.
This randomized controlled trial evaluated the effectiveness of an eight-week online group-based parent-mediated intervention (OYNA-1), based on NDBI principles, for preschool autistic children. Families were randomly assigned to either the intervention group or a waitlist control group. Parents in the intervention group participated in weekly online group sessions involving psychoeducation, therapist coaching, video-based feedback, and structured home practice, whereas families in the waitlist control group continued their usual educational services during the study period.
The primary objective was to compare changes in children's social communication skills between the intervention and waitlist control groups using the Social Communication Checklist-Revised (SCC-R). Secondary objectives were to compare changes in parental psychological distress, assessed with the Depression Anxiety Stress Scales-21 (DASS-21), and parental broad autism phenotype characteristics, assessed with the Broad Autism Phenotype Questionnaire (BAPQ), between groups. Participants in the intervention group also completed an additional assessment eight weeks after the intervention to evaluate the maintenance of treatment effects. Finally, demographic and clinical variables selected a priori based on clinical relevance were examined as potential predictors of improvements in children's social communication following the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a parallel-group design to either an online NDBI-based parent-mediated intervention or a waitlist control group. Outcome assessments were conducted at baseline and immediately after the intervention in both groups. Participants in the intervention group also completed a two-month follow-up assessment to evaluate the maintenance of treatment effects.
| Arm | Type | Receives |
|---|---|---|
| Online Parent-Mediated Intervention | Experimental | Behavioral: OYNA-1: Online Group-Based Parent-Mediated InterventionParticipants received an eight-week online parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles. The program included weekly group sessions consisting of psychoeducation, therapist coaching, video-based feedback, structured home practice, and individualized guidance. Participants continued to receive their usual educational services during the study period. |
| The control group | No intervention | –Participants remained on a waitlist during the study period and continued their usual educational services without receiving the online parent-mediated intervention. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 2 to 5 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- ASD diagnosis confirmed by an experienced child and adolescent psychiatrist.
- At least one parent or primary caregiver willing to participate in all intervention sessions.
- The same parent or primary caregiver available to participate throughout the study.
- Parents willing to complete all study assessments.
Key exclusion criteria (3 listed)
- Presence of genetic, neurological, or significant sensory disorders (e.g., hearing impairment) that could substantially affect child development.
- Participation in another structured parent-mediated intervention during the study period.
- -Inability of the participating parent to attend the intervention sessions or complete the study assessments.
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 |
|---|---|---|
| OYNA-1: Online Group-Based Parent-Mediated InterventionAn eight-week online parent-mediated intervention based on Naturalistic Developmental Behavioral Intervention (NDBI) principles. The program consisted of weekly online group sessions including psychoeducation, therapist coaching, video-based feedback, structured home practice, and individualized feedback. Parents were encouraged to implement the intervention strategies during everyday interactions with their children while continuing their usual educational services. | Behavioural | Online Parent-Mediated Intervention |
Primary outcome
Between-Group Difference in Social Communication Checklist-Revised Total Score After the 8-Week Intervention
Time frame: Baseline and immediately after the 8-week intervention
Children's social communication skills were assessed using the Social Communication Checklist-Revised (SCC-R), a 70-item parent-report measure for children aged 18 months to 6 years. The scale includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation and Play. Items are rated from 1 to 3, and total scores range from 70 to 210, with higher scores indicating better social communication skills. The primary analysis compared post-intervention SCC-R total scores between the intervention and waitlist control groups while adjusting for baseline SCC-R total scores. Secondary analyses also compared the four SCC-R subscale scores between groups.
6 secondary outcomes
Between-Group Difference in Depression Anxiety Stress Scales-21 Total and Subscale Scores After the 8-Week Intervention
Time frame: Baseline and immediately after the 8-week intervention.
Between-Group Difference in Broad Autism Phenotype Questionnaire Total and Subscale Scores After the 8-Week Intervention
Time frame: Baseline and immediately after the 8-week intervention.
Change in Social Communication Checklist-Revised Scores Through the 8-Week Follow-up in the Intervention Group
Time frame: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Change in Depression Anxiety Stress Scales-21 Scores Through the 8-Week Follow-up in the Intervention Group
Time frame: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Change in Broad Autism Phenotype Questionnaire Scores Through the 8-Week Follow-up in the Intervention Group
Time frame: Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.
Demographic and Clinical Factors Associated With Change in SCC-R Total Score
Time frame: Baseline and immediately after the 8-week intervention.
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 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent and ethics approval did not include provisions for public data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OYNA-1: Online Group-Based Parent-Mediated Intervention in people with Autism Spectrum Disorder, run by Herguner Therapy Private Clinic 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 7 inclusion and 3 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 11 Aug 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?
Between-Group Difference in Social Communication Checklist-Revised Total Score After the 8-Week Intervention (time frame: Baseline and immediately after the 8-week intervention). 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 11 Aug 2026.