Autism DisorderPTPNCT07075614
The Effectiveness of a Parent Training Program for Children With Autism Spectrum Disorder and High-Risk Infants: A Case-Control Study
A study testing Parent Training Program and routine care in people with Autism Disorder, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of a parent training program on the severity of autism-related symptoms in two groups: (1) infants under the age of 2 who show early signs of autism, and (2) children aged 2 to 5 years who have been diagnosed with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 0 months to 5 years
- Conditions the study is for
- Autism Disorder
- What is being tested?
- Parent Training Program and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having a child over the age of 2 diagnosed with Autism Spectrum Disorder (ASD), or having a high-risk infant under the age of 2 showing signs of autism
- Willingness to participate in the study
- Parent/caregiver must have completed at least primary school education
Who cannot join
- Refusal to participate in the study
- The child has a sensory, physical, or neurological disorder
- The parent or primary caregiver has a diagnosed psychiatric disorder that significantly impairs functioning
- The parent or caregiver has any physical illness that affects their interaction with the child (e.g., physical disability, visual or auditorial impairment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital
Istanbul
About this study
The aim of this study is to evaluate the effectiveness of a parent training program on the severity of autism-related symptoms in two groups: (1) infants under the age of 2 who show early signs of autism, and (2) children aged 2 to 5 years who have been diagnosed with Autism Spectrum Disorder (ASD). The study also aims to assess the program's impact on the quality of life and stress levels of the children's parents or caregivers.
The study will include children aged 0 to 5 years who are either considered at risk for autism or have an ASD diagnosis, along with their caregivers. A total of 250 participants are expected to enroll in the study. Informed consent will be obtained from all parents or caregivers before participation.
Read more
After consent, the 250 children will be randomly assigned to one of two groups:
Group A: Parent Training Program + Routine Care Group B: Routine Care Only While Group B will receive standard treatments such as education and psychotherapy and a single psychoeducational session about autism and its treatment, Group A will receive the same routine care plus the structured Parent Training Program.
Children in both groups will be assessed before the intervention begins and again after 12 weeks. Evaluations will be conducted with the support of professionals using standardized tools. Caregivers will complete a background information form with the help of the research team.
To assess symptom severity, the Modified Checklist for Autism in Toddlers (M-CHAT), the Childhood Autism Rating Scale (CARS), and the Clinical Global Impression Scale (CGI) will be administered by clinicians. General developmental levels will be evaluated using screening tools such as the Denver Developmental Screening Test or AGTE. Caregivers will also complete the Quality of Life in Autism-Parent Version and the Parenting Stress Index.
- Conditions
- Autism Disorder
- Being tested
- Parent Training Program, routine care
- Keywords
- autism, parent training program
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Training ProgramBehavioural
Also called Routine Care
Parent Training Programs are complementary interventions to special education, implemented by parents to support the social, cognitive, and behavioral development of children with autism and other developmental disorders.
Throughout the program, key developmental skills that children are expected to acquire-such as social skills (eye contact, joint attention, play, imitation), language, cognitive, motor, and self-care abilities-are explained using sample photos and simple instructions.
Additionally, the program provides guidance on how to foster secure attachment between parent and child and how to support social-communicative skills through warm, responsive interactions in daily life.
routine careOther
Also called Control Group
Standard care routinely provided to participants within clinical services
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Parent Training Program + Routine Care Receives: Behavioral: Parent Training Program |
| Control Group | Other | routine care Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Autism Severity as Measured by the Childhood Autism Rating Scale (CARS)
Autism severity will be assessed using the Childhood Autism Rating Scale (CARS), a clinician-rated tool that evaluates behavior in 15 areas related to communication, social interaction, and sensory responses. Each item is rated on a scale from 1 (no signs of autism) to 4 (severe symptoms), with a total score ranging from 15 to 60.
The total CARS score will be recorded at baseline (prior to intervention) and again.
The primary outcome is the change in total score, which reflects improvement or worsening in the severity of autism symptoms over time.
Measured: Baseline, After 1 and 3 Months from Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Jul 2024
- Primary completion31 Jan 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Other organizations
- Responsible party
- Principal investigator, Prof. Dr. Canan Tanıdır, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075614
- Sponsor's protocol ID
- HRU.23.20.36
- Acronym
- PTP
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Parent Training Program for Children With Autism Spectrum Disorder and High-Risk Infants: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07075614
- Acronym / sponsor ID
- PTP / HRU.23.20.36
- Conditions
- Autism Disorder
- Keywords
- autism, parent training program
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Collaborators
- Other organizations
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Jul 2025 (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.
The aim of this study is to evaluate the effectiveness of a parent training program on the severity of autism-related symptoms in two groups: (1) infants under the age of 2 who show early signs of autism, and (2) children aged 2 to 5 years who have been diagnosed with Autism Spectrum Disorder (ASD). The study also aims to assess the program's impact on the quality of life and stress levels of the children's parents or caregivers.
The study will include children aged 0 to 5 years who are either considered at risk for autism or have an ASD diagnosis, along with their caregivers. A total of 250 participants are expected to enroll in the study. Informed consent will be obtained from all parents or caregivers before participation.
After consent, the 250 children will be randomly assigned to one of two groups:
Group A: Parent Training Program + Routine Care Group B: Routine Care Only While Group B will receive standard treatments such as education and psychotherapy and a single psychoeducational session about autism and its treatment, Group A will receive the same routine care plus the structured Parent Training Program.
Children in both groups will be assessed before the intervention begins and again after 12 weeks. Evaluations will be conducted with the support of professionals using standardized tools. Caregivers will complete a background information form with the help of the research team.
To assess symptom severity, the Modified Checklist for Autism in Toddlers (M-CHAT), the Childhood Autism Rating Scale (CARS), and the Clinical Global Impression Scale (CGI) will be administered by clinicians. General developmental levels will be evaluated using screening tools such as the Denver Developmental Screening Test or AGTE. Caregivers will also complete the Quality of Life in Autism-Parent Version and the Parenting Stress Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Parent Training ProgramParent Training Program + Routine Care |
| Control Group | Other | Other: routine careroutine care |
Who may qualify
- Ages
- 0 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Having a child over the age of 2 diagnosed with Autism Spectrum Disorder (ASD), or having a high-risk infant under the age of 2 showing signs of autism
- Willingness to participate in the study
- Parent/caregiver must have completed at least primary school education
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- The child has a sensory, physical, or neurological disorder
- The parent or primary caregiver has a diagnosed psychiatric disorder that significantly impairs functioning
- The parent or caregiver has any physical illness that affects their interaction with the child (e.g., physical disability, visual or auditorial impairment)
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 |
|---|---|---|
| Parent Training ProgramAlso: Routine CareParent Training Programs are complementary interventions to special education, implemented by parents to support the social, cognitive, and behavioral development of children with autism and other developmental disorders. Throughout the program, key developmental skills that children are expected to acquire-such as social skills (eye contact, joint attention, play, imitation), language, cognitive, motor, and self-care abilities-are explained using sample photos and simple instructions. Additionally, the program provides guidance on how to foster secure attachment between parent and child and how to support social-communicative skills through warm, responsive interactions in daily life. | Behavioural | Intervention Group |
| routine careAlso: Control GroupStandard care routinely provided to participants within clinical services | Other | Control Group |
Primary outcome
Change from Baseline in Autism Severity as Measured by the Childhood Autism Rating Scale (CARS)
Time frame: Baseline, After 1 and 3 Months from Intervention
Autism severity will be assessed using the Childhood Autism Rating Scale (CARS), a clinician-rated tool that evaluates behavior in 15 areas related to communication, social interaction, and sensory responses. Each item is rated on a scale from 1 (no signs of autism) to 4 (severe symptoms), with a total score ranging from 15 to 60. The total CARS score will be recorded at baseline (prior to intervention) and again. The primary outcome is the change in total score, which reflects improvement or worsening in the severity of autism symptoms over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training Program and routine care in people with Autism Disorder, run by Umraniye Education and Research Hospital 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 1 May 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?
This study is still under way. Results are not available in the source record yet.
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 from Baseline in Autism Severity as Measured by the Childhood Autism Rating Scale (CARS) (time frame: Baseline, After 1 and 3 Months from Intervention). 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 1 May 2026.