NCT07075614

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: All
• Age: 0 Months – 5 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Autism Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Parent Training Program	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.

Timeline

• Start date: 2024-07-10
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: Turkey (Türkiye)