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NCT Number: NCT07742774

Online 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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sabri Hergüner Child and Adolescent Psychiatry Private Practice

Çankaya, Ankara, 06530, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

OYNA-1: Online Group-Based Parent-Mediated Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. Demographic and Clinical Factors Associated With Change in SCC-R Total Score

    Time frame: Baseline and immediately after the 8-week intervention.

    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.

Sponsors and collaborators

Lead sponsor

Herguner Therapy Private Clinic

Other

Registry information

Official study title

Effectiveness of an Online Group-Based Parent-Mediated Intervention for Preschool Autistic Children: A Randomized Controlled Trial

Acronym: OYNA-1

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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