What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) and Cognitive Enhancement Therapy (CET) are generally well-tolerated with minimal side effects, primarily involving temporary increases in anxiety or emotional discomfort as patients confront challenging thoughts and behaviors. Pharmacotherapy, often used alongside these therapies, includes selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Common side effects of these medications can include gastrointestinal issues, sleep disturbances, weight gain, and sexual dysfunction. It is important to monitor for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While Cognitive Enhancement Therapy (CET) and other cognitive remediation interventions are being studied for their potential benefits in improving cognitive and social functioning in individuals with ASD, they are not yet FDA-approved treatments. Current pharmacological treatments primarily focus on managing specific behavioral symptoms rather than enhancing cognitive functions.

What other types of research exist?

Enriched Supportive Therapy (EST) is a promising alternative to Cognitive Enhancement Therapy for adults with Autism Spectrum Disorder. EST focuses on helping individuals learn about their condition, manage emotions and stress, improve social skills, and cope with everyday problems. Additionally, music therapy, particularly improvisational music therapy, shows potential for improving language skills and social interaction in children with ASD.

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Cognitive Remediation

Cognitive Enhancement Therapy for Autism (PerspectivesII Trial)

Q: What is the mechanism of action of this treatment?

Cognitive Enhancement Therapy (CET) and similar cognitive remediation interventions aim to improve cognitive functions such as thinking, planning, and socialization in individuals with Autism Spectrum Disorder (ASD). These therapies typically involve structured tasks that target specific cognitive deficits, such as working memory and executive functioning, through repeated practice and gradual increase in task complexity. The importance of these treatments lies in their potential to enhance daily functioning and social interactions for ASD patients, thereby improving their overall quality of life and ability to integrate into various social and occupational settings.

N/A

Waitlist Available

Led By Nancy J Minshew, Ph.D.

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Age 16-45 years

Be younger than 65 years old

Must not have

Comorbid attention deficit hyperactivity disorder (ADHD) that is untreated

IQ < 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9, 18, and 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test two therapies for adults with autism. One therapy aims to improve thinking and planning through mental exercises. The other provides support to help manage emotions and social skills. The study focuses on adults because there are few treatments available for them.

Who is the study for?

Adults aged 16-45 with autism, Asperger's syndrome, or pervasive developmental disorder not otherwise specified (NOS), who have an IQ over 80 and significant social/cognitive challenges. Participants must speak English fluently, be able to attend sessions in Pittsburgh, PA, and have a supportive person for information sharing.

What is being tested?

The trial is testing Cognitive Enhancement Therapy (CET) against Enriched Supportive Therapy (EST). CET focuses on improving thinking and social skills while EST helps with understanding the condition, managing emotions/stress, enhancing social abilities, and problem-solving.

What are the potential side effects?

Since both interventions are psychological therapies rather than medications, they may cause emotional discomfort or distress. There might also be temporary increases in anxiety as participants work through personal challenges during therapy.

Eligibility Criteria

Inclusion Criteria

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

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I am between 16 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ADHD that has not been treated.

Select...

My IQ is below 80.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9, 18, and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9, 18, and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9, 18, and 30 months 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 Neurocognition

Change in Social cognition

Secondary study objectives

Change in Functional outcome

Other study objectives

Change in Processing Speed/Attention

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: Cognitive Enhancement TherapyExperimental Treatment1 Intervention

This research treatment aims to help with problems in thinking, planning, and socialization. Participants begin with cognitive training using computer software programs. They also participate in a small social-cognitive group to learn about their condition and how to act wisely in social situations by developing the abilities needed to understand another person's perspective, evaluate social contexts, and be foresightful. Time commitment: about 3½ hours per week; Location: Pittsburgh, PA only

Group II: Enriched Supportive TherapyActive Control1 Intervention

This research treatment uses individual supportive therapy to help adults learn about autism spectrum disorder, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies. Time commitment: about 1 hour per week; Location: Pittsburgh, PA only

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Enhancement Therapy

2012

N/A

~160

0 / 3Eligibility 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

Cognitive Enhancement Therapy (CET) and similar cognitive remediation interventions aim to improve cognitive functions such as thinking, planning, and socialization in individuals with Autism Spectrum Disorder (ASD). These therapies typically involve structured tasks that target specific cognitive deficits, such as working memory and executive functioning, through repeated practice and gradual increase in task complexity. The importance of these treatments lies in their potential to enhance daily functioning and social interactions for ASD patients, thereby improving their overall quality of life and ability to integrate into various social and occupational settings.

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.