Online Parent-Mediated Intervention for Preschool Autistic Children: A Randomized Controlled Trial

NCT07742774 | Completed

• 1 other identifier: OYNA1-RCT-2026-07
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Autism Spectrum Disorder

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline, immediately after the 8-week intervention, and 8 weeks after intervention completion.

Study Arms (2)

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.

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.

Interventions

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.

Online Parent-Mediated Intervention

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herguner Therapy Private Clinic: lead

Study Sites (1)

Sabri Hergüner Child and Adolescent Psychiatry Private Practice

Çankaya, Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not feasible because of the nature of the behavioral parent-mediated intervention. Participants and intervention providers were aware of group allocation. Outcome measures (SCC-R, DASS-21, and BAPQ) were completed by parents using self-report questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child and Adolescent Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: December 27, 2022
• Primary Completion: June 10, 2023
• Study Completion: August 13, 2023
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)