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Early Intervention Program for Young Children with Developmental Disorders

This study is looking at a 12-week early intervention program for children aged 2 to 5 years old who have developmental disorders like Autism Spectrum Disorder or intellectual disability. The program involves 12 hours of treatment each week, either in a center-based preschool setting or at home. Researchers want to see if this program can improve social communication skills in these children. Success will be measured by changes in a parent-rated survey about social responsiveness after 12 weeks. The study plans to enroll 75 children, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 75 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive 12 weekly hours of treatment for 12 weeks, either in a center-based preschool environment or in their home. They will also complete a parent-rated survey at the beginning and end of the treatment period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at baseline and after 12 weeks of treatment.

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NCT04026386

A Center Based Early Intervention Program For Preschoolers With Developmental Disorders

Recruiting
NAAges 2–5InterventionalTreatment
Stanford University
~75 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Center Based or In Home Early Intervention Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Measured over Baseline, 12 Weeks

Conditions

Development Disorder, Child
Developmental Disability
Development Delay
Autism Spectrum Disorder

Explore related trials

Autism Spectrum DisorderDevelopmental DisorderIntellectual DisabilityNeurosis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Antonio Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Madeleine Clark, BS
[email protected]
(650) 736-1235
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
Boys and girls between 2.0 years and 5.11 years at time of enrollment;
Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion

Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
Lack of availability during program hours.

What this trial measures

  • Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.Baseline, 12 Weeks

    Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )