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Clinical Trials/NCT03170453
NCT03170453
Completed
Not Applicable

Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

University of Pittsburgh1 site in 1 country86 target enrollmentJune 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autistic Disorder
Sponsor
University of Pittsburgh
Enrollment
86
Locations
1
Primary Endpoint
Change in Social cognition
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2015
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaun M. Eack

Professor of Social Work and Psychiatry

University of Pittsburgh

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Change in Social cognition

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in Functional outcome(Baseline, 9, 18, and 30 months)

Study Sites (1)

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