The Effectiveness of a Parent Training Program for Children With Autism Spectrum Disorder and High-Risk Infants: A Case-Control Study

Enrolling by invitation · Not applicable

Conditions studied: Autism Disorder

In brief

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.

Key facts

Study ID

NCT07075614

Run by

Umraniye Education and Research Hospital

People needed

250

Starts

2024-07-10

Expected to finish

2026-05-01

Last updated by the study team

2026-05-01

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Umraniye Training and Research Hospital — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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