Cognitive Enhancement Therapy for Adults With Autism Spectrum Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00902798
First received: May 13, 2009
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

This study will contrast the effects of a therapy for improving thinking and brain function in people with autism, Asperger's syndrome, or pervasive developmental disorder with a therapy designed to improve emotion regulation and management.


Condition Intervention Phase
Autistic Disorder
Behavioral: Cognitive Enhancement Therapy
Behavioral: Enriched Supportive Therapy
Phase 1

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: Adapting Cognitive Enhancement Therapy for ASD

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Cognitive Assessment Battery, including the NIMH-Measurement and Treatment Research to Improve Cognition in Schizophrenia (NIMH-MATRICS) Battery and the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: Measured at baseline and at 9 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Assessment Battery (Social, Role, Vocational) [ Time Frame: Measured at baseline and at 9 and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: April 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Enhancement Therapy
Participants will receive cognitive enhancement therapy.
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
Participants will receive Enriched Supportive Therapy.
Behavioral: Enriched Supportive Therapy
An 18-month intervention that uses individual supportive therapy to help adults learn about their condition, 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, Asperger's syndrome, and pervasive developmental disorder are all autism spectrum disorders (ASD), which are characterized by specific impairments in social interactions, communication, and imaginative play and by restricted and repetitive interests and behavior. These impairments stem from problems in underlying cognition and information processing. ASDs are often treated in childhood, but no attempt has been made to improve cognition and brain deficits in adults with ASDs, who often experience difficulty in understanding social situations, thinking abstractly, and taking the perspective of others. Cognitive enhancement therapy (CET) is a treatment that has proved effective in improving cognition in individuals with schizophrenia. This study will compare the benefits of CET on cognition and brain function in adults with ASDs to Enriched Supportive Therapy (EST), an intervention designed to improve emotion management and regulation.

Participation in this study will last 18 months. Potential participants must be able to attend weekly treatment sessions in Pittsburgh, PA. The first 12 participants will be assigned to receive CET. All other participants will be randomly assigned to receive either CET or EST. Some participants will also be selected to complete a magnetic resonance imaging (MRI) assessment, which will involve performing tasks while undergoing a brain scan.

Participants assigned to receive CET will complete three different weekly study visits: a group, an individual, and a computer visit. Participants will receive training in attention, memory, and problem solving abilities through computer training and will develop problem solving and communication skills through the group sessions. The CET treatment will require approximately 3 to 3.5 hours a week for up to 18 months.

Participants assigned to receive EST will meet individually with a therapist to learn about their condition, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will also learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies. The EST treatment will require approximately 1 hour a week for up to 18 months.

All participants will complete assessments at baseline and after 9 and 18 months. Assessments will include a cognitive testing session, in which participants complete a reading and intelligence test; an interview with a researcher, in which participants will be asked about the symptoms of their disorder; and an interview with a family member or close friend of the participant, which will involve questions about the participant's disorder. Participants assigned to MRI will undergo the procedure at baseline and 18 months.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of autism, Asperger's syndrome, or pervasive developmental disorder not otherwise specified (NOS) verified by the autism diagnostic observation schedule (ADOS) and autism diagnostic interview-revised (ADI-R)
  • Presence of significant social and cognitive disability, based on the cognitive style and social cognition eligibility interview
  • Intelligence quotient (IQ) greater than 80
  • Ability to read and speak fluent English
  • 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)
  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
Investigators
Principal Investigator: Nancy J. Minshew, MD University of Pittsburgh
Principal Investigator: Shaun M. Eack, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00902798     History of Changes
Other Study ID Numbers: R33 MH085851, R33MH085851, R21MH085851, AR100344, 05381, 2008NF-Autism
Study First Received: May 13, 2009
Last Updated: January 6, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 16, 2014