What side effects are associated with this type of intervention?

Behavioral strategies and role-play techniques, such as those used in the SENSE Theatre® program, are generally considered safe and have minimal side effects. These interventions focus on enhancing social skills through structured activities, peer modeling, and repeated practice. Common side effects may include temporary increases in anxiety or stress as individuals are exposed to new social situations and challenges. However, these effects are typically mild and can be managed with appropriate support and gradual exposure.

What prior FDA approvals exist?

As of now, the FDA has not approved any drugs specifically for the core symptoms of Autism Spectrum Disorder (ASD). However, certain medications are approved to manage associated symptoms such as irritability, including risperidone and aripiprazole. Behavioral interventions like those used in SENSE Theatre®, which incorporate role-play and social skills training, are widely recognized and supported by research but do not require FDA approval as they are non-pharmacological. These interventions aim to enhance social cognition and behavior through structured activities and peer interactions.

What other types of research exist?

Promising, novel alternatives to SENSE Theatre® for Autism Spectrum Disorder patients include: 1) Integrating live dogs into interventions to promote social motivation and imitation skills. 2) Music-based interventions, such as using sung speech to improve socio-communicative responsiveness. 3) Immersive theater experiences specifically designed for individuals with ASD to enhance engagement and satisfaction. 4) Video modeling techniques to teach various social and safety skills, such as reciprocal pretend play and abduction-prevention skills.

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SENSE Theatre for Autism

N/A

Waitlist Available

Led By Blythe A Corbett, Ph.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Peers must be at least 18 years of age

Confederates must be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pretest, week 5, week 11, two-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests SENSE Theatre®, a program that uses acting to help adults with autism improve their social skills. It focuses on practicing face recognition and social interactions through repeated role-playing activities. The goal is to see if these improvements last. SENSE Theatre® is a novel intervention that combines trained peers to facilitate performance-based theatrical treatment in a supportive, community-based environment.

Who is the study for?

This trial is for adults with Autism Spectrum Disorder (ASD) who are not in educational programs. They must have an IQ of 70 or above, be diagnosed by a specialist confirmed with ADOS-2, and show interest in improving social skills. Excluded are those with suicidal tendencies, uncontrolled aggression, intellectual impairment below the set IQ threshold, or previous SENSE Theatre participants.

What is being tested?

SENSE Theatre is being tested as an intervention to improve social competence in adults with ASD. It uses peer models, scripted and improvised role-play from theatre techniques to enhance social cognition and behavior through repeated practice.

What are the potential side effects?

There may not be traditional medical side effects since this is a behavioral intervention; however, participants might experience anxiety or stress during performances or interactions. The impact varies among individuals.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am at least 18 years old.

Select...

I am at least 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pretest, week 5, week 11, two-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pretest, week 5, week 11, two-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and pretest, week 5, week 11, two-month follow-up 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 Contextual Assessment of Social Skills

Change in Incidental Face Memory

Change in Social Responsiveness Scale - Parent (SRS)

+1 more

Secondary study objectives

Adaptive Behavior Assessment System (ABAS) - Parent-Report

Adaptive Behavior Assessment System (ABAS) - Self-Report

Cambridge Face Memory Test

+5 more

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: SENSE TheatreExperimental Treatment1 Intervention

A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.

Group II: Waitlist Control GroupActive Control1 Intervention

This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SENSE Theatre

2014

N/A

~460

0 / 2Eligibility 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) that use behavioral strategies and role-play, such as those in SENSE Theatre®, work by enhancing social cognition and behavior. These treatments involve trained peer models, predictable and flexible role-play, and repeated performance of social skills. This structured yet dynamic approach helps individuals with ASD practice and internalize social interactions, which is crucial for improving their social communication abilities and reducing social anxiety.

What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Outcomes and moderators of Early Start Denver Model intervention in young children with autism spectrum disorder delivered in a mixed individual and group setting.Neural Mechanisms of Qigong Sensory Training Massage for Children With Autism Spectrum Disorder: A Feasibility Study.