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

NCT ID: NCT07075614

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Parent Training Program + Routine Care

Group Type: ACTIVE_COMPARATOR

Parent Training Program

Intervention Type: 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.

Control Group

Routine Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Instıtute of Child And Adolescent Psychiatry

UNKNOWN

Sponsor Role: collaborator

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Dr. Canan Tanıdır

Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HRU.23.20.36

Identifier Type: -

Identifier Source: org_study_id