Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder (Perspectives)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Pittsburgh
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Autism Speaks
United States Department of Defense
Pennsylvania Department of Health
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00902798
First received: May 13, 2009
Last updated: December 16, 2015
Last verified: December 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Pittsburgh:

Primary Outcome Measures:
  • Neurocognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ] [ Designated as safety issue: No ]
    Composite measure of neuropsychological tests designed to assess neurocognitive function

  • Social cognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ] [ Designated as safety issue: No ]
    Composite measure of performance-based and interview tests designed to assess social-cognitive function


Secondary Outcome Measures:
  • Adaptive Function [ Time Frame: Pre-treatment, 9, 18, and 30 months ] [ Designated as safety issue: No ]
    Composite measure of interview assessments of adaptive function


Estimated Enrollment: 169
Study Start Date: April 2009
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (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

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902798

Contacts
Contact: Autism Recruiter 1-866-647-3436 autismrecruiter@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
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: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00902798     History of Changes
Other Study ID Numbers: MH085851/MH106450  R33MH085851  R21MH085851  AR100344  05381  2008NF-Autism  R01MH106450  ARI2014 
Study First Received: May 13, 2009
Last Updated: December 16, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Asperger Syndrome
Autistic Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on February 07, 2016