Effectiveness of an Online Group-Based Parent-Mediated Intervention for Preschool Autistic Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Between-Group Difference in Social Communication Checklist-Revised Total Score After the 8-Week Intervention
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Online Parent-Mediated Intervention
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.
Intervention: OYNA-1: Online Group-Based Parent-Mediated Intervention (Behavioral)
The control group
Participants remained on a waitlist during the study period and continued their usual educational services without receiving the online parent-mediated intervention.
Outcomes
Primary Outcomes
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
- 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.)
- Demographic and Clinical Factors Associated With Change in SCC-R Total Score(Baseline and immediately after the 8-week intervention.)
Investigators
Sabri Hergüner
Child and Adolescent Psychiatrist
Herguner Therapy Private Clinic