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Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder (Perspectives)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902798
First Posted: May 15, 2009
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Autism Speaks
United States Department of Defense
Pennsylvania Department of Health
Information provided by (Responsible Party):
Shaun M. Eack, University of Pittsburgh
  Purpose
This study will investigate and contrast the effects 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.

Condition Intervention
Autistic Disorder Autism Spectrum Disorder Asperger's Syndrome Pervasive Developmental Disorder Behavioral: Cognitive Enhancement Therapy Behavioral: Enriched Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Shaun M. Eack, University of Pittsburgh:

Primary Outcome Measures:
  • Neurocognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
    Composite measure of neuropsychological tests designed to assess neurocognitive function

  • Social cognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
    Composite measure of performance-based and interview tests designed to assess social-cognitive function


Secondary Outcome Measures:
  • Functional outcome [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
    Functional Assessment Battery (Social, Role, Vocational)


Enrollment: 54
Actual Study Start Date: August 2010
Estimated Study Completion Date: October 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Enhancement Therapy

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

Behavioral: Cognitive Enhancement Therapy
An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.
Active Comparator: Enriched Supportive Therapy

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

Behavioral: Enriched Supportive Therapy
An 18-month intervention that 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.

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 contrast the effects 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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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)
  • Comorbid personality disorder
  • History of disruptive or violent behavior
  • Any magnetic resonance imaging contraindications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902798


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Autism Speaks
United States Department of Defense
Pennsylvania Department of Health
Investigators
Principal Investigator: Shaun M. Eack, PhD University of Pittsburgh
Principal Investigator: Nancy J. Minshew, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Shaun M. Eack, Professor of Social Work and Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00902798     History of Changes
Other Study ID Numbers: MH085851
R33MH085851 ( U.S. NIH Grant/Contract )
R21MH085851 ( U.S. NIH Grant/Contract )
AR100344 ( Other Grant/Funding Number: Department of Defense )
05381 ( Other Grant/Funding Number: Autism Speaks )
2008NF-Autism ( Other Grant/Funding Number: Pennsylvania Department of Health )
ARI2014 ( Other Grant/Funding Number: Autism Research Institute )
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared through the National Database for Autism Research

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shaun M. Eack, University of Pittsburgh:
Autism
Autism Spectrum Disorders
Asperger's Syndrome
Pervasive Developmental Disorder
Cognition
Social Cognition
Psychosocial Treatment
Cognitive Enhancement Therapy
Enriched Supportive Therapy
Therapy
Psychotherapy

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders