Autism Spectrum DisorderNCT07416903
Multicomponent Group Parent Program Incorporating Naturalistic Teaching in Türkiye
A study testing Multicomponent Group Parent Program Incorporating Naturalistic Teaching and General Parenting Comparison Seminar in people with Autism Spectrum Disorder and Parenting Self-efficacy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This randomized study examined a 10-session multicomponent group parent program incorporating Naturalistic Teaching principles for caregivers of autistic children enrolled in preschool or early intervention services in Türkiye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Parenting Self-efficacy
- What is being tested?
- Multicomponent Group Parent Program Incorporating Naturalistic Teaching and General Parenting Comparison Seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2023to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caregiver (18 years or older).
- Primary caregiver of a child with an autism spectrum disorder diagnosis who was enrolled in preschool or early intervention services.
- Able to complete study assessments and, if assigned to the intervention arm, attend the in-person group sessions.
- Provided written informed consent.
Who cannot join
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şerife Bacı Special Education Preschool
Osmangazi, Bursa, 16040
About this study
Official title: A Randomized Trial of a Multicomponent Group Parent Program Incorporating Naturalistic Teaching for Caregivers of Autistic Children in Türkiye
This randomized study examined a 10-session multicomponent group parent program incorporating Naturalistic Teaching principles for caregivers of autistic children enrolled in preschool or early intervention services in Türkiye. Twenty-four caregivers were randomized in a 1:1:1 ratio to the multicomponent group parent program, a single-session general parenting comparison seminar, or a wait-list control. Parental self-efficacy was assessed at baseline and post-test in all three study arms using two subscales: Accessing Services and Supports and Parenting Strategies. An approximately 9-month follow-up assessment was conducted in the intervention arm only. The present analyses examine between-group change in the two parental self-efficacy domains, while post-test retention and intervention-session attendance are summarized descriptively as study-process indicators.
Read the detailed description
The intervention consisted of 10 weekly group sessions of approximately 90 minutes each. The program combined Naturalistic Teaching-related interaction strategies with broader psychoeducational content addressing autism, feeding and sleep routines, challenging behavior, caregiver stress, guided practice, group discussion, and between-session activities. The general parenting comparison condition consisted of one approximately 60-minute seminar covering general parenting topics such as sleep hygiene, nutrition, and screen use; it did not include autism-specific information or Naturalistic Teaching strategies. Participants assigned to the wait-list condition received no program during the study period and were provided access to program materials after post-test assessment. Parental self-efficacy was assessed at baseline and post-test in all three randomized arms using the Accessing Services and Supports and Parenting Strategies subscales. An approximately 9-month follow-up assessment was conducted in the intervention arm only.
- Conditions
- Autism Spectrum Disorder, Parenting Self-efficacy
- Being tested
- Multicomponent Group Parent Program Incorporating Naturalistic Teaching, General Parenting Comparison Seminar
- Keywords
- Naturalistic Teaching, Psychoeducation, Parent-mediated intervention, Caregivers, Early intervention, Parent training, Routine-based strategies, Randomized trial, Parental self-efficacy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Group Parent Program Incorporating Naturalistic TeachingBehavioural
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.
General Parenting Comparison SeminarBehavioural
A single-session general parenting seminar (approximately 60 minutes) focusing on general parenting topics without autism-specific content.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Group Parent Program Incorporating Naturalistic Teaching | Experimental | A 10-session multicomponent group parent program incorporating Naturalistic Teaching principles, delivered weekly for approximately 90 minutes. The program included autism-related psychoeducation, Naturalistic Teaching strategies, feeding and sleep routines, challenging behavior, caregiver stress, guided practice, group discussion, and between-session activities. Receives: Behavioral: Multicomponent Group Parent Program Incorporating Naturalistic Teaching |
| General Parenting Comparison Seminar | Active comparator | Participants received one approximately 60-minute general parenting seminar covering topics such as sleep hygiene, nutrition, and screen use. The seminar did not include autism-specific information or Naturalistic Teaching strategies and was not matched to the intervention for contact time, group exposure, or intervention intensity. Receives: Behavioral: General Parenting Comparison Seminar |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accessing Services and Supports Subscale Score
Change from baseline to post-test in the Accessing Services and Supports subscale of the 13-item Turkish-language Parental Self-Efficacy Instrument for Children with Disabilities. The subscale comprises 5 items (Items 1, 2, 3, 4, and 6), with possible scores ranging from 5 to 35. Higher scores indicate greater parental self-efficacy in accessing services and supports. Change scores are calculated as post-test minus baseline.
Measured: Baseline and post-test at the end of the 10-week intervention period
Change in Parenting Strategies Subscale Score
Change from baseline to post-test in the Parenting Strategies subscale of the 13-item Turkish-language Parental Self-Efficacy Instrument for Children with Disabilities. The subscale comprises 8 items (Items 5, 7, 8, 9, 10, 11, 12, and 13), with possible scores ranging from 8 to 56. Higher scores indicate greater parental self-efficacy in parenting strategies. Change scores are calculated as post-test minus baseline.
Measured: Baseline and post-test at the end of the 10-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start29 Dec 2023
- Primary completion15 Apr 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel-group randomized trial comparing a 10-session multicomponent group parent program, a single-session general parenting comparison seminar, and a wait-list control.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Nejat Akfırat, Kocaeli University
- Investigators
- Türker Orkun Arslan, MA, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416903
- Sponsor's protocol ID
- KOCAELI-NT-PARENT-2023-01
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified participant-level data may be made available on reasonable request, subject to applicable ethical and institutional requirements and consideration of re-identification risk in this small sample.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Multicomponent Group Parent Program Incorporating Naturalistic Teaching for Caregivers of Autistic Children in Türkiye
- ClinicalTrials.gov ID
- NCT07416903
- Acronym / sponsor ID
- KOCAELI-NT-PARENT-2023-01
- Conditions
- Autism Spectrum Disorder, Parenting Self-efficacy
- Keywords
- Naturalistic Teaching, Psychoeducation, Parent-mediated intervention, Caregivers, Early intervention, Parent training, Routine-based strategies, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized study examined a 10-session multicomponent group parent program incorporating Naturalistic Teaching principles for caregivers of autistic children enrolled in preschool or early intervention services in Türkiye. Twenty-four caregivers were randomized in a 1:1:1 ratio to the multicomponent group parent program, a single-session general parenting comparison seminar, or a wait-list control. Parental self-efficacy was assessed at baseline and post-test in all three study arms using two subscales: Accessing Services and Supports and Parenting Strategies. An approximately 9-month follow-up assessment was conducted in the intervention arm only. The present analyses examine between-group change in the two parental self-efficacy domains, while post-test retention and intervention-session attendance are summarized descriptively as study-process indicators.
Detailed description
The intervention consisted of 10 weekly group sessions of approximately 90 minutes each. The program combined Naturalistic Teaching-related interaction strategies with broader psychoeducational content addressing autism, feeding and sleep routines, challenging behavior, caregiver stress, guided practice, group discussion, and between-session activities. The general parenting comparison condition consisted of one approximately 60-minute seminar covering general parenting topics such as sleep hygiene, nutrition, and screen use; it did not include autism-specific information or Naturalistic Teaching strategies. Participants assigned to the wait-list condition received no program during the study period and were provided access to program materials after post-test assessment. Parental self-efficacy was assessed at baseline and post-test in all three randomized arms using the Accessing Services and Supports and Parenting Strategies subscales. An approximately 9-month follow-up assessment was conducted in the intervention arm only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm parallel-group randomized trial comparing a 10-session multicomponent group parent program, a single-session general parenting comparison seminar, and a wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Group Parent Program Incorporating Naturalistic Teaching | Experimental | Behavioral: Multicomponent Group Parent Program Incorporating Naturalistic TeachingA 10-session multicomponent group parent program incorporating Naturalistic Teaching principles, delivered weekly for approximately 90 minutes. The program included autism-related psychoeducation, Naturalistic Teaching strategies, feeding and sleep routines, challenging behavior, caregiver stress, guided practice, group discussion, and between-session activities. |
| General Parenting Comparison Seminar | Active comparator | Behavioral: General Parenting Comparison SeminarParticipants received one approximately 60-minute general parenting seminar covering topics such as sleep hygiene, nutrition, and screen use. The seminar did not include autism-specific information or Naturalistic Teaching strategies and was not matched to the intervention for contact time, group exposure, or intervention intensity. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult caregiver (18 years or older).
- Primary caregiver of a child with an autism spectrum disorder diagnosis who was enrolled in preschool or early intervention services.
- Able to complete study assessments and, if assigned to the intervention arm, attend the in-person group sessions.
- Provided written informed consent.
Key exclusion criteria (1 listed)
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Group Parent Program Incorporating Naturalistic TeachingA 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. | Behavioural | Multicomponent Group Parent Program Incorporating Naturalistic Teaching |
| General Parenting Comparison SeminarA single-session general parenting seminar (approximately 60 minutes) focusing on general parenting topics without autism-specific content. | Behavioural | General Parenting Comparison Seminar |
Primary outcome
Change in Accessing Services and Supports Subscale Score
Time frame: Baseline and post-test at the end of the 10-week intervention period
Change from baseline to post-test in the Accessing Services and Supports subscale of the 13-item Turkish-language Parental Self-Efficacy Instrument for Children with Disabilities. The subscale comprises 5 items (Items 1, 2, 3, 4, and 6), with possible scores ranging from 5 to 35. Higher scores indicate greater parental self-efficacy in accessing services and supports. Change scores are calculated as post-test minus baseline.
Change in Parenting Strategies Subscale Score
Time frame: Baseline and post-test at the end of the 10-week intervention period
Change from baseline to post-test in the Parenting Strategies subscale of the 13-item Turkish-language Parental Self-Efficacy Instrument for Children with Disabilities. The subscale comprises 8 items (Items 5, 7, 8, 9, 10, 11, 12, and 13), with possible scores ranging from 8 to 56. Higher scores indicate greater parental self-efficacy in parenting strategies. Change scores are calculated as post-test minus baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified participant-level data may be made available on reasonable request, subject to applicable ethical and institutional requirements and consideration of re-identification risk in this small sample.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Türker Orkun Arslan, MA study director
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Group Parent Program Incorporating Naturalistic Teaching and General Parenting Comparison Seminar in people with Autism Spectrum Disorder and Parenting Self-efficacy, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Accessing Services and Supports Subscale Score (time frame: Baseline and post-test at the end of the 10-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.