What side effects are associated with this type of intervention?

Behavioral and educational interventions for ASD, such as ABA, ESDM, and SCERTS, generally have minimal side effects, primarily involving the potential for stress or frustration in children due to the intensity and structure of the programs. Complementary therapies like omega-3 fatty acid supplementation are generally well-tolerated but can cause gastrointestinal distress, such as nausea and diarrhea. Overall, these treatments are considered safe, with the primary focus on their effectiveness in improving social communication and adaptive behaviors.

What prior FDA approvals exist?

Currently, the FDA has approved only a few medications specifically for the treatment of Autism Spectrum Disorder (ASD). These include antipsychotic drugs such as risperidone and aripiprazole, which are primarily used to manage irritability and aggression associated with ASD. There are no FDA-approved medications specifically targeting core symptoms like language and social skills deficits. However, ongoing research and trials, such as the school-based treatment aimed at increasing language and social skills, are exploring new avenues for intervention, though these are not yet approved by the FDA.

What other types of research exist?

Promising, novel alternatives to school-based treatments for ASD patients include: 1) High-tech Speech Generating Devices (SGDs) which have shown effectiveness in teaching social communication behaviors. 2) The Therapeutic Outcomes By You application, an information communication technology-based intervention that has demonstrated long-term improvements in language and social communication skills. 3) The Aquatic Speech and Language Therapy (ASLT) program, which utilizes an aquatic environment to potentially enhance language skills. 4) The UCLA PEERS® Program, which focuses on the education and enrichment of relational skills through structured social skills training.

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Behavioral Intervention

Social and Communication Intervention for Autism

N/A

Waitlist Available

Led By Rebecca Landa, PhD, CCC-SLP

Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children must be between the ages of 3 and 6 and enrolled in a participating ASD preschool classroom.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a school program designed to help young children with autism improve their language and social skills. It focuses on preschool-aged children who need extra help in these areas. Teachers are trained to use special techniques and get feedback to improve their methods.

Who is the study for?

This trial is for preschoolers aged 3-6 with autism spectrum disorder (ASD) who are enrolled in certain Baltimore County Public School ASD classrooms. Participants must meet specific diagnostic criteria for ASD and have an IQ or Developmental Quotient of at least 40. Preschool educators working in these classrooms can also join.

What is being tested?

The study is testing the ISC+PRT Intervention, a school-based treatment designed to improve language and social skills in children with ASD. The intervention will be refined through educator feedback and aims to be practical for real-world application.

What are the potential side effects?

Since this is a behavioral intervention focusing on education techniques, traditional medical side effects are not applicable. However, there may be variations in individual responses to the intervention's activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 3 and 6 years old and attends an ASD preschool.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4-, 8-, 12-, 16-, 20-, 24-, 28-, 32-, and 36-weeks into the intervention 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 in educator instruction to meet fidelity of intervention.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ISC+PRT InterventionExperimental Treatment1 Intervention

For the duration of at least one school year children will receive 45-90 minutes of intervention in the classroom in an attempt to increase social and communication skills.

Group II: Instruction As UsualActive Control1 Intervention

For the duration of at least one year children will receive the typical classroom instruction

0 / 1Eligibility 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 behavioral and educational interventions such as Applied Behavior Analysis (ABA), the Early Start Denver Model (ESDM), and the SCERTS program. These treatments focus on improving social communication, adaptive behavior, and cognitive skills through structured, individualized, and intensive therapy sessions. Parent and educator involvement is crucial for reinforcing skills across different settings, promoting generalization and long-term improvement. Understanding these mechanisms helps tailor interventions to individual needs, ensuring more effective and sustainable outcomes for ASD patients.

Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.Pivotal response treatment for preschoolers with autism spectrum disorder: Defining a predictor profile.