What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that involve structured, intensive interaction and learning activities, such as Applied Behavior Analysis (ABA) and the Early Start Denver Model (ESDM), generally have minimal physical side effects. However, they can be intensive and demanding, potentially leading to stress or burnout for both the child and the family. Behavioral interventions may sometimes cause temporary increases in challenging behaviors as new skills are being learned. It is crucial to monitor the child's response to these interventions and adjust the approach as needed to ensure it remains supportive and effective.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. These medications are not directly related to structured, intensive interaction and learning activities but are used to manage behavioral symptoms. For treatments similar to the Early Intervention Program, which focuses on structured and intensive interaction, behavioral and educational interventions are commonly recommended. These include Applied Behavior Analysis (ABA), speech therapy, and occupational therapy, which are not FDA-regulated but are widely used and supported by clinical guidelines for improving social communication and adaptive skills in children with ASD.

What other types of research exist?

Promising novel alternatives to structured, intensive early intervention programs for ASD patients include: 1) The Nova Scotia Early Intensive Behavior Intervention (NS EIBI) model, which combines parent training with naturalistic one-to-one behavior intervention using Pivotal Response Treatment (PRT). 2) The Early Start Denver Model (ESDM) integrated into community preschools, which has shown effectiveness in improving developmental outcomes. 3) The Incredible Years® Autism Spectrum and Language Delays (IY-ASLD) parent program, which focuses on caregiver-mediated interventions and has demonstrated feasibility and preliminary effectiveness in randomized controlled trials.

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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

Summary

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.

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.

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.

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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My child is between 2 and 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.

Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Center Based or In-Home Early Intervention ProgramExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include structured, intensive interaction and learning activities such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS model. ABA uses reinforcement strategies to improve specific behaviors, ESDM combines ABA with developmental and relationship-based approaches to enhance cognitive and language skills, and SCERTS focuses on social communication and emotional regulation. These treatments are crucial as they target core deficits in ASD, such as social communication challenges and adaptive functioning, promoting better long-term developmental outcomes.

Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Pivotal response treatment for preschoolers with autism spectrum disorder: Defining a predictor profile.