NCT07763067

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 8, 2026

Last Update Submit

August 8, 2026

Conditions

Keywords

autism spectrum disorderparent-mediated interventiontelehealthparent coachingsocial communicationacceptabilityearly interventionTürkiye

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Baseline and immediately after completion of the 8-week intervention

  • Parent Satisfaction With the OYNA Intervention Assessed by the Parent Satisfaction Questionnaire

    Immediately after completion of the 8-week intervention

  • Comparison of Maternal and Paternal Social Communication Checklist-Revised (SCC-R) Scores

    Baseline and immediately after completion of the 8-week intervention

  • Comparison of Maternal and Paternal Depression Anxiety Stress Scales-21 (DASS-21) Scores

    Baseline and immediately after completion of the 8-week intervention

  • Comparison of Maternal and Paternal Parent Satisfaction Questionnaire Scores

    Immediately after completion of the 8-week intervention

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Online Group-Based Parent-Mediated Intervention (OYNA)

Interventions

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.

OYNA Intervention Group

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabri Hergüner Private Clinic

Çankaya, Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCommunication

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Child and Adolescent Psychiatry

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 13, 2026

Study Start

October 3, 2022

Primary Completion

December 24, 2022

Study Completion

December 24, 2022

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations