Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder (Perspectives)
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Purpose
| 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 |
- 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
- 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 (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00902798
| Contact: Autism Recruiter | 1-866-647-3436 | autismrecruiter@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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 |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data will be shared through the National Database for Autism Research |
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:
|
Disease Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Asperger Syndrome |
Developmental Disabilities Pathologic Processes Neurodevelopmental Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 29, 2016