NCT07416903

Brief Summary

This pilot randomized study examines the feasibility and preliminary effects of a Naturalistic Teaching (NT)-based group psychoeducation program for parents of autistic preschool children in Türkiye. After providing consent, parents are randomized to one of three conditions: (1) a 10-week NT-based group psychoeducation program delivered weekly (90 minutes per session), (2) a single-session general parenting seminar that does not include autism-specific content (attention control), or (3) a wait-list control group that receives access to intervention materials after the post-test. The primary outcome is parental self-efficacy, assessed using parent-report questionnaires. Outcomes are measured at baseline and post-test, and a later follow-up assessment is used to evaluate whether improvements are maintained. The study also tracks feasibility indicators such as retention and session attendance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 9, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Naturalistic TeachingPsychoeducationParent-mediated interventionCaregiversPreschoolEarly interventionParent trainingRoutine-based strategiesRandomized trial

Outcome Measures

Primary Outcomes (1)

  • Parental Self-Efficacy Score (Turkish Early Intervention Parenting Self-Efficacy Scale)

    Change in parental self-efficacy from baseline to post-test, assessed using the Turkish Early Intervention Parenting Self-Efficacy Scale (13 items; total score range 13-91; 7-point Likert responses; higher scores indicate greater parental self-efficacy \[better outcome\]). The scale includes the Accessing Services and Supports and Parenting Strategies subscales.

    Baseline and 10 weeks (post-test)

Secondary Outcomes (1)

  • Retention Rate

    Baseline to post-test (end of week 10)

Other Outcomes (1)

  • Parental Self-Efficacy Score at Follow-up

    Approximately 9 months after post-test

Study Arms (3)

NT-Based Group Psychoeducation

EXPERIMENTAL

Participants receive a Naturalistic Teaching (NT)-based group psychoeducation program consisting of 10 weekly sessions (90 minutes each) for parents of autistic preschool children.

Behavioral: NT-Based Group Psychoeducation

Attention Control: General Parenting Seminar

ACTIVE COMPARATOR

Participants receive a single-session general parenting seminar (approximately 60 minutes) that does not include autism-specific content (attention control).

Behavioral: General Parenting Seminar (Attention Control)

Wait-List Control

NO INTERVENTION

Participants receive no intervention during the study period and are offered access to intervention materials after the post-test assessment.

Interventions

A Naturalistic Teaching (NT)-based group psychoeducation program delivered in 10 weekly sessions (90 minutes each) for parents of autistic preschool children, focusing on routine-embedded strategies and parent empowerment.

NT-Based Group Psychoeducation

A single-session general parenting seminar (approximately 60 minutes) focusing on general parenting topics without autism-specific content.

Attention Control: General Parenting Seminar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18 years or older).
  • Primary caregiver (e.g., mother/father) of a preschool-aged child with autism spectrum disorder.
  • Able to attend the sessions (if assigned to the intervention/attention control) and complete study questionnaires.
  • Provides informed consent.

You may not qualify if:

  • Inability to provide informed consent.
  • Insufficient proficiency in Turkish to complete questionnaires and participate in sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Education

Kocaeli, Izmit, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Türker Orkun Arslan, MA

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 18, 2026

Study Start

December 29, 2023

Primary Completion

April 15, 2024

Study Completion

January 13, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in the manuscript.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months after study completion and ending 5 years after study completion.
Access Criteria
IPD and supporting documents will be shared upon reasonable request to the corresponding author after publication. Requests will be reviewed for scientific merit and compliance with ethics approval and applicable regulations. Data will be provided in de-identified form only, to qualified researchers for non-commercial purposes, under a data use agreement, and via a secure file transfer method.

Locations