Early Intervention Program for Autism Spectrum Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Antonio Hardan, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a program where children spend time each week in a special preschool or at home doing activities. The goal is to help children with developmental disorders, like Autism, improve their social communication skills. By engaging in these structured activities, the children can learn to communicate and interact better.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Early Intervention Program for Autism Spectrum Disorder is an effective treatment?

The available research shows that Early Intervention Programs for Autism Spectrum Disorder can lead to significant improvements in various developmental areas for children with autism. For example, one study found that children who participated in early intensive behavioral intervention (EIBI) showed significant gains in intellectual functioning and a decrease in autism symptom severity after treatment. However, these gains in symptom severity were not maintained a year after the treatment ended. Another study highlighted that community-based early intervention programs generally result in medium-to-large improvements compared to usual treatments. While some studies suggest that the benefits of these programs may diminish over time, they still indicate that early intervention can be more effective than standard treatments in the short term. Additionally, the Frankfurt Early Intervention Program (FFIP) showed improvements in socialization and mental age, although these gains were smaller compared to more intensive programs. Overall, the research supports the effectiveness of early intervention programs, especially when compared to typical treatments, but also suggests the need for ongoing support to maintain these benefits. ^{1 2 3 4 5}

What safety data exists for early intervention programs for autism?

The research indicates that early intensive behavioral interventions (EIBI) and models like the Early Start Denver Model (ESDM) are effective and feasible for young children with autism spectrum disorder (ASD). These interventions have shown positive outcomes in community settings, with high parent satisfaction and good treatment fidelity. However, specific safety data is not detailed in the provided studies, suggesting a need for further research to document safety and effectiveness comprehensively. ^{5 6 7 8 9}

Is the Center Based Early Intervention Program a promising treatment for autism spectrum disorder?

Yes, the Center Based Early Intervention Program is a promising treatment for autism spectrum disorder. Research shows that early intervention programs, like the Early Start Denver Model and Early Intensive Behavioral Intervention, lead to significant improvements in communication, social skills, and behavior for children with autism. These programs are well-supported by parents and therapists, and they are effective in community settings. ^{2 5 8 10 11}

Research Team

Antonio Hardan, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with a developmental disorder like autism.

I am between 2 and 4 years old.

I have been diagnosed with a developmental disorder like autism.

Exclusion Criteria

Lack of availability during program hours

Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week early intervention program in an intensive center-based preschool environment or in the home

12 weeks

12 weekly sessions

Follow-up

Participants are monitored for changes in social communication deficits after treatment

4 weeks

Treatment Details

Interventions

• Center Based Early Intervention Program (Behavioural Intervention)
• Center Based or In Home Early Intervention Program (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Center Based or In-Home Early Intervention Program Experimental Treatment 1 Intervention

Center Based Early Intervention Program is already approved in Canada for the following indications:

Approved in Canada as Early Childhood Intervention for:

• Developmental delays
• Autism Spectrum Disorder
• Neurogenetic disorders

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

John & Marcia Goldman Foundation

Collaborator

Trials

2

Recruited

120+

Findings from Research

A follow-up study involving 41 children with autism, who previously participated in a 2-year early intensive behavioral intervention (EIBI), found that the initial benefits of the intervention diminished over a 2-year period after it ended.

Children who received parent-commissioned interventions showed better outcomes compared to those who had university-supervised interventions, highlighting the importance of tailoring support to individual needs and the potential necessity for ongoing maintenance programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes for children with autism after the cessation of early intensive behavioral intervention. Kovshoff, H., Hastings, RP., Remington, B.[2019]

Children with autism spectrum disorders showed significant improvements in intellectual functioning and reduced autism symptom severity after participating in a low-to-moderate intensity early intensive behavioral intervention (EIBI) program for 10 to 20 hours per week.

While the gains in intellectual functioning were maintained one year after treatment, the reduction in autism symptom severity reverted to near pretreatment levels, highlighting the need for ongoing support to sustain behavioral improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-Up of Children With Autism Spectrum Disorder 1 Year After Early Behavioral Intervention. Rivard, M., Morin, M., Mello, C., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Two-year outcomes for children with autism after the cessation of early intensive behavioral intervention. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of community-based early intervention for children with autism spectrum disorder: a meta-analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Follow-Up of Children With Autism Spectrum Disorder 1 Year After Early Behavioral Intervention. [2020]

4. Austria pubmed.ncbi.nlm.nih.gov

The Frankfurt early intervention program FFIP for preschool aged children with autism spectrum disorder: a pilot study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral interventions for children with autism spectrum disorders. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Behavioral intervention for preschool children with autism – outcome of parent-based Intervention]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Expanding Access to Clinical Services for Toddlers with Autism Spectrum Disorders. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Outcomes of the Early Start Denver Model Delivered within the Public Health System of the Friuli Venezia Giulia Italian Region. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Outcome survey of early intensive behavioral intervention for young children with autism in a community setting. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD). [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Parents' experiences of home-based applied behavior analysis programs for young children with autism. [2021]