Cognitive Enhancement Therapy for Adults With Autism Spectrum Disorders
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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 |
- 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 ]
- 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 |
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| Contact: Autism Recruiter | 1-866-647-3436 | autismrecruiter@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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 Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013