Autism Spectrum DisorderNCT07763067
Acceptability and Outcomes of an Online Parent-Mediated Intervention for Young Autistic Children
A study testing Online Group-Based Parent-Mediated Intervention (OYNA) in people with Autism Spectrum Disorder, run by Herguner Therapy Private Clinic at 1 site in Turkey (Türkiye).
Trial summary
This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of an 8-week online group-based parent-mediated intervention (OYNA) for parents of young autistic children. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Online Group-Based Parent-Mediated Intervention (OYNA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 24 Dec 2022
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria
- Child aged 2-6 years
- Parent willingness to participate in all intervention sessions
- Participation of the same parent throughout the intervention program
- Agreement not to initiate another intervention program during the study period
Who cannot join
- Presence of medical conditions that could affect development, including genetic disorders, neurological disorders, or hearing impairment
- Participation in another structured intervention program during the study period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sabri Hergüner Private Clinic
Çankaya, Ankara, 06530
About this study
Official title: Acceptability and Preliminary Clinical Outcomes of an Online Group-Based Parent-Mediated Intervention for Young Autistic Children: A Pre-Post Study From Türkiye
This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of an 8-week online group-based parent-mediated intervention (OYNA) for parents of young autistic children. Mothers and fathers independently completed assessments of their child's social communication skills and their own psychological distress at baseline and immediately after the intervention. The study was designed to examine pre-post changes in children's social communication and parental psychological distress and to compare maternal and paternal assessments at both time points. Parent satisfaction with the program was assessed following the intervention, and demographic and clinical factors associated with parent satisfaction were also examined.
Read the detailed description
Autism is a neurodevelopmental condition characterized by persistent difficulties in social communication and the presence of restricted and repetitive behaviors. Parent-mediated interventions aim to equip caregivers with strategies that can be incorporated into everyday interactions with their children. Online group-based delivery may facilitate access to such interventions by reducing geographical and logistical barriers.
The OYNA program is an 8-week online group-based parent-mediated intervention for parents of young autistic children. The program incorporates psychoeducation, behavioral and developmental strategies, video-based coaching, therapist feedback, and structured home practice to support parents in applying intervention strategies during everyday interactions with their children.
This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of the OYNA program. Both mothers and fathers participated in the assessment process and independently completed measures concerning their child and their own psychological well-being. Children's social communication skills were assessed using the Social Communication Checklist-Revised (SCC-R), and parental psychological distress was assessed using the Depression Anxiety Stress Scales-21 (DASS-21) at baseline and immediately after the intervention.
The study was designed to examine changes in SCC-R and DASS-21 scores from baseline to post-intervention. Maternal and paternal SCC-R and DASS-21 scores were also compared at baseline and post-intervention to examine differences between parental reports. Agreement between maternal and paternal ratings of children's social communication was additionally evaluated.
Following completion of the intervention, mothers and fathers completed a Parent Satisfaction Questionnaire assessing satisfaction with the program, perceived benefits for their child, confidence in applying the strategies learned during the intervention, and their overall evaluation of the program. Maternal and paternal satisfaction scores were compared.
Finally, the study examined demographic and clinical factors associated with parent satisfaction.Child- and parent-related demographic and clinical characteristics, baseline parental psychological distress, and change in children's social communication were evaluated as potential factors associated with parent satisfaction.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Online Group-Based Parent-Mediated Intervention (OYNA)
- Keywords
- autism spectrum disorder, parent-mediated intervention, telehealth, parent coaching, social communication, acceptability, early intervention, Türkiye
- 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.
Online Group-Based Parent-Mediated Intervention (OYNA)Behavioural
The OYNA program was an 8-week online group-based parent-mediated intervention for parents of young autistic children. The intervention consisted of weekly online group sessions incorporating psychoeducation, behavioral and developmental strategies, therapist guidance, video-based coaching and feedback, and structured home practice. Parents were taught strategies to support their children's social communication and developmental skills and were encouraged to apply these strategies during everyday interactions and routines.
| Study group | Role | What they receive |
|---|---|---|
| OYNA Intervention Group | Experimental | Participants received the 8-week online group-based parent-mediated intervention (OYNA). The program consisted of weekly online group sessions including psychoeducation, behavioral and developmental strategies, video-based coaching and feedback, and structured home practice. Parents were supported in applying the strategies during everyday interactions and activities with their children. Receives: Behavioral: Online Group-Based Parent-Mediated Intervention (OYNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Social Communication Assessed by the Social Communication Checklist-Revised (SCC-R)
The Social Communication Checklist-Revised (SCC-R) is a 70-item parent-report measure used to assess social communication abilities in young children. It includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play Skills. Items are rated on a three-point scale, with higher scores indicating better social communication abilities. Mothers and fathers independently completed the SCC-R for the same child at baseline and immediately after the intervention. Changes in the SCC-R total score and domain scores from baseline to post-intervention were evaluated, with an increase in scores indicating improvement in social communication skills.
Measured: Baseline and immediately after completion of the 8-week intervention
Secondary outcomes (6)
Change in Parental Psychological Distress Assessed by the Depression Anxiety Stress Scales-21 (DASS-21)
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report measure used to assess parental psychological distress. It consists of three 7-item subscales assessing depression, anxiety, and stress. Each item is rated on a 4-point scale from 0 to 3. Subscale scores were multiplied by 2, resulting in possible scores ranging from 0 to 42 for each subscale and from 0 to 126 for the total score. Higher scores indicate greater psychological distress. Mothers and fathers independently completed the DASS-21 at baseline and immediately after the intervention. Changes in the DASS-21 total and subscale scores from baseline to post-intervention were evaluated separately for mothers and fathers.
Measured: Baseline and immediately after completion of the 8-week intervention
Parent Satisfaction With the OYNA Intervention Assessed by the Parent Satisfaction Questionnaire
Parent satisfaction with the intervention was assessed using a 13-item Parent Satisfaction Questionnaire administered immediately after completion of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 to 5, resulting in a total score ranging from 13 to 65. Higher total scores indicate greater satisfaction with the intervention. The questionnaire assesses parents' perceptions of the usefulness and applicability of the intervention strategies, satisfaction with the program and their child's progress, perceived improvements in their child's social communication and developmental skills, increased confidence in supporting their child, and overall satisfaction with the intervention. Mothers and fathers completed the questionnaire independently.
Measured: Immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Social Communication Checklist-Revised (SCC-R) Scores
The Social Communication Checklist-Revised (SCC-R) is a 70-item parent-report measure used to assess social communication abilities in young children. It includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play Skills. Items are rated on a three-point scale, with higher scores indicating better social communication abilities. Mothers and fathers independently completed the SCC-R for the same child. Maternal and paternal SCC-R total scores were compared at baseline and immediately after the intervention. Agreement between maternal and paternal SCC-R ratings was also evaluated.
Measured: Baseline and immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Depression Anxiety Stress Scales-21 (DASS-21) Scores
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report measure assessing depression, anxiety, and stress. It consists of three 7-item subscales. Each item is rated from 0 to 3, and subscale scores were multiplied by 2. Each subscale therefore ranges from 0 to 42, and the total score ranges from 0 to 126. Higher scores indicate greater psychological distress. Mothers and fathers independently completed the DASS-21. Maternal and paternal DASS-21 total scores were compared at baseline and immediately after the intervention.
Measured: Baseline and immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Parent Satisfaction Questionnaire Scores
Parent satisfaction with the intervention was assessed using a 13-item Parent Satisfaction Questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 to 5, resulting in a total score ranging from 13 to 65. Higher total scores indicate greater satisfaction with the intervention. Mothers and fathers independently completed the questionnaire immediately after the intervention. Maternal and paternal total satisfaction scores were compared.
Measured: Immediately after completion of the 8-week intervention
Factors Associated With Parent Satisfaction With the OYNA Intervention
Parent satisfaction with the intervention was assessed using a 13-item Parent Satisfaction Questionnaire administered immediately after completion of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 to 5, resulting in a total score ranging from 13 to 65, with higher scores indicating greater satisfaction with the intervention. Factors associated with the Parent Satisfaction Questionnaire total score were examined using hierarchical multiple linear regression analysis. Child age, child sex, and weekly hours of outside educational intervention were entered in the first block as demographic and clinical variables. Baseline parental psychological distress, assessed using the DASS-21 total score, and change in children's social communication, assessed using the SCC-R total score from baseline to post-intervention, were entered in the second block to examine their additional contribution to parent satisfaction.
Measured: Immediately after completion of 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 posted13 Aug 2026
- Study start3 Oct 2022
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
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
- This was a single-group pre-post intervention study. All participating families received the 8-week online group-based parent-mediated intervention (OYNA), with assessments conducted at baseline and immediately after the intervention.
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT07763067
- Sponsor's protocol ID
- OYNA1-Satisfaction-2026-08
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Preliminary Clinical Outcomes of an Online Group-Based Parent-Mediated Intervention for Young Autistic Children: A Pre-Post Study From Türkiye
- ClinicalTrials.gov ID
- NCT07763067
- Acronym / sponsor ID
- OYNA1-Satisfaction-2026-08
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, parent-mediated intervention, telehealth, parent coaching, social communication, acceptability, early intervention, Türkiye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Herguner Therapy Private ClinicUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 13 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.
This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of an 8-week online group-based parent-mediated intervention (OYNA) for parents of young autistic children. Mothers and fathers independently completed assessments of their child's social communication skills and their own psychological distress at baseline and immediately after the intervention. The study was designed to examine pre-post changes in children's social communication and parental psychological distress and to compare maternal and paternal assessments at both time points. Parent satisfaction with the program was assessed following the intervention, and demographic and clinical factors associated with parent satisfaction were also examined.
Detailed description
Autism is a neurodevelopmental condition characterized by persistent difficulties in social communication and the presence of restricted and repetitive behaviors. Parent-mediated interventions aim to equip caregivers with strategies that can be incorporated into everyday interactions with their children. Online group-based delivery may facilitate access to such interventions by reducing geographical and logistical barriers.
The OYNA program is an 8-week online group-based parent-mediated intervention for parents of young autistic children. The program incorporates psychoeducation, behavioral and developmental strategies, video-based coaching, therapist feedback, and structured home practice to support parents in applying intervention strategies during everyday interactions with their children.
This preliminary single-arm pre-post interventional study was designed to evaluate the acceptability and preliminary clinical outcomes of the OYNA program. Both mothers and fathers participated in the assessment process and independently completed measures concerning their child and their own psychological well-being. Children's social communication skills were assessed using the Social Communication Checklist-Revised (SCC-R), and parental psychological distress was assessed using the Depression Anxiety Stress Scales-21 (DASS-21) at baseline and immediately after the intervention.
The study was designed to examine changes in SCC-R and DASS-21 scores from baseline to post-intervention. Maternal and paternal SCC-R and DASS-21 scores were also compared at baseline and post-intervention to examine differences between parental reports. Agreement between maternal and paternal ratings of children's social communication was additionally evaluated.
Following completion of the intervention, mothers and fathers completed a Parent Satisfaction Questionnaire assessing satisfaction with the program, perceived benefits for their child, confidence in applying the strategies learned during the intervention, and their overall evaluation of the program. Maternal and paternal satisfaction scores were compared.
Finally, the study examined demographic and clinical factors associated with parent satisfaction.Child- and parent-related demographic and clinical characteristics, baseline parental psychological distress, and change in children's social communication were evaluated as potential factors associated with parent satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-group pre-post intervention study. All participating families received the 8-week online group-based parent-mediated intervention (OYNA), with assessments conducted at baseline and immediately after the intervention.
| Arm | Type | Receives |
|---|---|---|
| OYNA Intervention Group | Experimental | Behavioral: Online Group-Based Parent-Mediated Intervention (OYNA)Participants received the 8-week online group-based parent-mediated intervention (OYNA). The program consisted of weekly online group sessions including psychoeducation, behavioral and developmental strategies, video-based coaching and feedback, and structured home practice. Parents were supported in applying the strategies during everyday interactions and activities with their children. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Confirmed diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria
- Child aged 2-6 years
- Parent willingness to participate in all intervention sessions
- Participation of the same parent throughout the intervention program
- Agreement not to initiate another intervention program during the study period
Key exclusion criteria (2 listed)
- Presence of medical conditions that could affect development, including genetic disorders, neurological disorders, or hearing impairment
- Participation in another structured intervention program during the study period
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 (OYNA)The OYNA program was an 8-week online group-based parent-mediated intervention for parents of young autistic children. The intervention consisted of weekly online group sessions incorporating psychoeducation, behavioral and developmental strategies, therapist guidance, video-based coaching and feedback, and structured home practice. Parents were taught strategies to support their children's social communication and developmental skills and were encouraged to apply these strategies during everyday interactions and routines. | Behavioural | OYNA Intervention Group |
Primary outcome
Change in Child Social Communication Assessed by the Social Communication Checklist-Revised (SCC-R)
Time frame: Baseline and immediately after completion of the 8-week intervention
The Social Communication Checklist-Revised (SCC-R) is a 70-item parent-report measure used to assess social communication abilities in young children. It includes four domains: Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play Skills. Items are rated on a three-point scale, with higher scores indicating better social communication abilities. Mothers and fathers independently completed the SCC-R for the same child at baseline and immediately after the intervention. Changes in the SCC-R total score and domain scores from baseline to post-intervention were evaluated, with an increase in scores indicating improvement in social communication skills.
6 secondary outcomes
Change in Parental Psychological Distress Assessed by the Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Baseline and immediately after completion of the 8-week intervention
Parent Satisfaction With the OYNA Intervention Assessed by the Parent Satisfaction Questionnaire
Time frame: Immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Social Communication Checklist-Revised (SCC-R) Scores
Time frame: Baseline and immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Depression Anxiety Stress Scales-21 (DASS-21) Scores
Time frame: Baseline and immediately after completion of the 8-week intervention
Comparison of Maternal and Paternal Parent Satisfaction Questionnaire Scores
Time frame: Immediately after completion of the 8-week intervention
Factors Associated With Parent Satisfaction With the OYNA Intervention
Time frame: Immediately after completion of 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 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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 Online Group-Based Parent-Mediated Intervention (OYNA) 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 5 inclusion and 2 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 13 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?
Change in Child Social Communication Assessed by the Social Communication Checklist-Revised (SCC-R) (time frame: Baseline and immediately after completion of 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 13 Aug 2026.