Effectiveness of Cognitive Enhancement Therapy for Young Adults With Autism Spectrum Disorders - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00902798

Purpose

This study will test a therapy for improving thinking and brain function in people with autism, Asperger's syndrome, or pervasive developmental disorder.

Condition	Intervention	Phase
Autistic Disorder	Behavioral: Cognitive Enhancement Therapy Behavioral: Treatment as Usual	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Adapting Cognitive Enhancement Therapy for ASD

Resource links provided by NLM:

MedlinePlus related topics: Asperger's Syndrome Autism Developmental Disabilities

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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
1: Experimental 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
2: Active Comparator Participants will receive treatment as usual.	Behavioral: Treatment as Usual The usual care individuals with autism spectrum disorders receive in the community

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 test whether CET can improve cognition and brain functioning in adults with ASDs.

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 usual care as part of the control group. Some participants will also be randomly 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.

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:	18 Years to 30 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

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

Contacts

Contact: Dave Maloney

1-866-647-3436

autismrecruiter@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Nancy J. Minshew, MD	University of Pittsburgh
Principal Investigator:	Shaun M. Eack, PhD	University of Pittsburgh

More Information

Publications:

Hogarty GE, Flesher S, Ulrich R, Carter M, Greenwald D, Pogue-Geile M, Kechavan M, Cooley S, DiBarry AL, Garrett A, Parepally H, Zoretich R. Cognitive enhancement therapy for schizophrenia: effects of a 2-year randomized trial on cognition and behavior. Arch Gen Psychiatry. 2004 Sep;61(9):866-76.

Hogarty GE, Greenwald DP, Eack SM. Durability and mechanism of effects of cognitive enhancement therapy. Psychiatr Serv. 2006 Dec;57(12):1751-7.

Eack SM, Hogarty GE, Greenwald DP, Hogarty SS, Keshavan MS. Cognitive enhancement therapy improves emotional intelligence in early course schizophrenia: preliminary effects. Schizophr Res. 2007 Jan;89(1-3):308-11. Epub 2006 Oct 19.

Responsible Party:	University of Pittsburgh ( Allen A. DiPalma, Director of Research )
Study ID Numbers:	R21 MH085851, DDTR B2-MBA, GRANT00475979, NIH #1R21MH085851-01
Study First Received:	May 13, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00902798 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

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:

Child Development Disorders, Pervasive
Pathologic Processes
Disease

Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 05, 2009