Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

Not Applicable

Completed

• Conditions: Asperger Syndrome; Autistic Disorder; Autism Spectrum Disorder; Pervasive Developmental Disorder

• Registration Number: NCT03170453
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will investigate and confirm the efficacy of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.

Detailed Description

Autism spectrum disorder (ASD) is characterized by marked impairments in social and non-social cognitive ability that persist well into adulthood and contribute to significant functional disability. The treatment of ASD has focused almost exclusively on children, and few empirically supported interventions are available to address the core cognitive and functional challenges individuals with ASD face as they transition to adulthood. This study will investigate and confirm the efficacy of two psychological treatments for adults with autism spectrum disorder. Cognitive Enhancement Therapy (CET) is a cognitive remediation intervention that aims to help adults with problems in thinking, planning, and socialization. Enriched Supportive Therapy (EST) is an individual supportive therapy that aims to help adults learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems.

Participation in this study will last 30 months. Potential participants must be able to attend weekly treatment sessions in Pittsburgh, PA.

The study design is a 30-month (2.5 years) randomized-controlled confirmatory efficacy trial, where eligible participants will be randomized to the CET or EST study treatments. Participants will be treated with the study interventions for 18 months, and then followed for 12 additional months to assess the lasting impact of the study interventions. All participants will complete cognitive, clinical, and neuroimaging (magnetic resonance imaging) assessments prior to starting the study treatments and then at specified intervals thereafter to evaluate the impact of the study treatments on cognition, adaptive function, and the brain.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-05-31
• Primary Completion: 2022-05-04
• Status Verified: 2024-06
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Age 16-45 years
• Diagnosis of autism, Asperger's syndrome, or pervasive developmental disorder not otherwise specified (NOS) verified by the autism diagnostic observation schedule (ADOS) or autism diagnostic interview-revised (ADI-R)
• Presence of significant social and cognitive disability, based on the Cognitive Style and Social Cognition Eligibility Interview (Hogarty et al., 2004)
• Intelligence quotient (IQ) greater than 80
• Ability to read and speak fluent English
• Availability of a family member or close friend allowed to provide information on the participant
• Ability to attend weekly treatment sessions in Pittsburgh, PA

Exclusion Criteria

• Organic brain syndrome
• IQ < 80
• English language skills below a sixth grade level
• Persistent suicidal or homicidal behavior
• History of substance abuse or dependence within the past 3 months
• Comorbid attention deficit hyperactivity disorder (ADHD) that is untreated
• Comorbid personality disorder
• History of disruptive or violent behavior
• Any magnetic resonance imaging contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Social cognition	Baseline, 9, 18, and 30 months	Composite measure of performance-based and interview tests designed to assess social-cognitive function. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome.
Change in Neurocognition	Pre-treatment, 9, 18, and 30 months	Composite measure of neuropsychological tests designed to assess neurocognitive function. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Functional outcome	Baseline, 9, 18, and 30 months	Composite measure of interview assessments of social, vocational, interpersonal, independent living, and other domains of functional outcome. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States