Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT04026386

Conditions

Development Disorder, Child

Developmental Disability

Development Delay

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

Interventions

Center Based or In Home Early Intervention Program

Study Details

Brief summary:

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.

Conditions

Development Disorder, Child

Developmental Disability

Development Delay

Autism Spectrum Disorder

Study ID

NCT04026386

Start date

Oct 19, 2019

Status verified date

Jun, 2026

Completion date

Dec 30, 2034

Anticipated

Primary completion date

Dec 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Center Based or In-Home Early Intervention Program

Interventions

Center Based or In Home Early Intervention Program

This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Madeleine Clark, BS

(650) 736-1235PALprogram@stanford.edu

Beatrice Begley, BS

(650) 736-1235PALprogram@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Madeleine Clark, BS

650-736-1235PALprogram@stanford.edu

Beatrice Begley, BS

(650) 736-1235PALprogram@stanford.edu

Principal Investigator:

Antonio Hardan, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-25.