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Early Intervention Program for Autism Spectrum Disorder

N/A
Recruiting
Led By Antonio Hardan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 4.11 years at time of enrollment;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights

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.

Who is the study for?
This trial is for preschool-aged children (2 to almost 5 years old) diagnosed with developmental disorders like Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability. They must be able to complete certain tests and have no severe psychiatric conditions like bipolar disorder.Check my eligibility
What is being tested?
The study is testing a 12-week early intervention program aimed at improving social communication in young children with developmental disorders. It compares two settings: an intensive center-based preschool environment and in-home treatment.See study design
What are the potential side effects?
Since this trial involves educational and behavioral interventions rather than medication, traditional side effects are not applicable. However, there may be stress or fatigue associated with participation in the programs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a developmental disorder like autism.
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I am between 2 and 4 years old.
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I have been diagnosed with a developmental disorder like autism.
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I can complete required tests accurately.
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My child is between 2 and 5 years old.
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I can complete required tests accurately.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Secondary outcome measures
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.
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Center Based or In-Home Early Intervention ProgramExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,284 Total Patients Enrolled
32 Trials studying Autism Spectrum Disorder
3,978 Patients Enrolled for Autism Spectrum Disorder
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
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)
8 Previous Clinical Trials
352 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
157 Patients Enrolled for Autism Spectrum Disorder

Media Library

Center Based Early Intervention Program Clinical Trial Eligibility Overview. Trial Name: NCT04026386 — N/A
Autism Spectrum Disorder Research Study Groups: Center Based or In-Home Early Intervention Program
Autism Spectrum Disorder Clinical Trial 2023: Center Based Early Intervention Program Highlights & Side Effects. Trial Name: NCT04026386 — N/A
Center Based Early Intervention Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04026386 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this clinical investigation?

"Affirmative. Clinicaltrials.gov's records indicate that this clinical trial, which was first uploaded on October 19th 2019, is still recruiting participants. They need to find 75 volunteers from one medical site."

Answered by AI

Are there any openings available in this clinical trial?

"Indeed, the information found on clinicaltrials.gov reveals that this medical experiment is actively recruiting participants. It was initially posted on October 19th 2019 and modified recently on February 15th 2022. The study requires 75 patients from one location to take part in the trial."

Answered by AI

Do I possess the necessary qualifications to register for this clinical experiment?

"This study seeks to enroll 75 children between the ages of two and four who have been medically diagnosed with Autism Spectrum Disorder. Necessary criteria for admission include an ability to engage in standardized testing, a developmental disorder (e.g., ASD or neurogenetic disorder), gender, and age at enrollment time."

Answered by AI

Does the research include participants aged 85 and over?

"As per the eligibility requirements, this trial is targeting patients aged 2 to 4. Notably, there are 422 studies for minors and 659 trials available for senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
< 18
What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~10 spots leftby Dec 2024