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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: NT-Based Group Psychoeducation
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).
Behavioral: General Parenting Seminar (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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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