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

NCT07075614 | Enrolling By Invitation

• 1 other identifier: HRU.23.20.36
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

autism; parent training program

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, After 1 and 3 Months from Intervention

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Parent Training Program + Routine Care

Behavioral: Parent Training Program

Control Group

OTHER

routine care

Other: routine care

Interventions

Parent Training Program BEHAVIORAL

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.

Also known as: Routine Care

Intervention Group

routine care OTHER

Standard care routinely provided to participants within clinical services

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 0 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Other organizations: collaborator
• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: July 10, 2024
• Primary Completion: January 31, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)