Center Based Early Intervention Program for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism Spectrum Disorder+6 More
Center Based Early Intervention Program - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if a 12-week early intervention program that includes 12 weekly hours in an intensive center-based preschool environment is effective in treating social communication deficits in children with developmental disorders.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders
  • Development Disorder, Child
  • Development Delay
  • Disability, Developmental

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline, 12 Weeks

Baseline, 12 Weeks
Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment.
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.
Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Center Based Early Intervention Program
1 of 1
Experimental Treatment

75 Total Participants · 1 Treatment Group

Primary Treatment: Center Based Early Intervention Program · No Placebo Group · N/A

Center Based Early Intervention Program
Behavioral
Experimental Group · 1 Intervention: Center Based Early Intervention Program · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 12 weeks

Who is running the clinical trial?

John & Marcia Goldman FoundationUNKNOWN
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
44 Patients Enrolled for Autism Spectrum Disorder
Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,679,093 Total Patients Enrolled
27 Trials studying Autism Spectrum Disorder
2,346 Patients Enrolled for Autism Spectrum Disorder
Antonio Hardan, MDPrincipal Investigator - Stanford University
Lucile Packard Children's Hospital Stanford, Mills-Peninsula Medical Center
St Joseph'S University (Medical School)
University Hlth Ctr Of Pittsburgh (Residency)
7 Previous Clinical Trials
292 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
157 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to participate in the testing procedures to the extent that valid standard scores can be obtained.
You are between 2.0 and 4.11 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
< 18100.0%
What site did they apply to?
Stanford University School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%