- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416903
NT-Based Group Psychoeducation for Parents of Autistic Preschoolers in Türkiye
February 13, 2026 updated by: Osman Nejat Akfırat, Kocaeli University
A Naturalistic Teaching-Based Group Psychoeducation Program for Parents of Autistic Preschoolers in Türkiye: A Mixed-Methods Pilot Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The intervention is a Naturalistic Teaching (NT)-based group psychoeducation program for parents of autistic preschool children.
The program includes 10 weekly sessions (90 minutes each) focused on increasing parents' confidence and skills to use everyday routines to support their child, with emphasis on routine-embedded strategies and parent empowerment.
The comparator conditions include an attention control (single-session general parenting seminar) and a wait-list control.
The primary outcome is parental self-efficacy; secondary outcomes include feasibility indicators (retention and attendance) and maintenance assessed at follow-up on January 13, 2025.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Izmit
-
Kocaeli, Izmit, Turkey (Türkiye), 41001
- Kocaeli University, Faculty of Education
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability to provide informed consent.
- Insufficient proficiency in Turkish to complete questionnaires and participate in sessions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NT-Based Group Psychoeducation
Participants receive a Naturalistic Teaching (NT)-based group psychoeducation program consisting of 10 weekly sessions (90 minutes each) for parents of autistic preschool children.
|
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.
|
|
Active Comparator: Attention Control: General Parenting Seminar
Participants receive a single-session general parenting seminar (approximately 60 minutes) that does not include autism-specific content (attention control).
|
A single-session general parenting seminar (approximately 60 minutes) focusing on general parenting topics without autism-specific content.
|
|
No Intervention: Wait-List Control
Participants receive no intervention during the study period and are offered access to intervention materials after the post-test assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Self-Efficacy Score (Turkish Early Intervention Parenting Self-Efficacy Scale)
Time Frame: Baseline and 10 weeks (post-test)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention Rate
Time Frame: Baseline to post-test (end of week 10)
|
Baseline and 10 weeks (post-test)
|
Baseline to post-test (end of week 10)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Self-Efficacy Score at Follow-up
Time Frame: Approximately 9 months after post-test
|
Parental self-efficacy assessed at follow-up to examine maintenance of post-test gains, using the Turkish Early Intervention Parenting Self-Efficacy Scale (13 items; total score range 13-91; higher scores indicate greater parental self-efficacy [better outcome]).
If follow-up was collected only for the intervention arm, this outcome applies to the intervention arm only.
|
Approximately 9 months after post-test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Türker Orkun Arslan, MA, Kocaeli University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2023
Primary Completion (Actual)
April 15, 2024
Study Completion (Actual)
January 13, 2025
Study Registration Dates
First Submitted
February 9, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Approval No: 2023/06-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data (IPD) that underlie the results reported in the manuscript.
IPD Sharing Time Frame
Beginning 3 months after study completion and ending 5 years after study completion.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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