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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH106450 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will investigate and confirm the efficacy 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.
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 confirm the efficacy 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 confirmatory efficacy 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Enhancement Therapy | Experimental | 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 |
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| Enriched Supportive Therapy | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Enhancement Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurocognition | Composite measure of neuropsychological tests designed to assess neurocognitive function. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome. | Pre-treatment, 9, 18, and 30 months |
| Change in Social cognition | Composite measure of performance-based and interview tests designed to assess social-cognitive function. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome. | Baseline, 9, 18, and 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional outcome | Composite measure of interview assessments of social, vocational, interpersonal, independent living, and other domains of functional outcome. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome. | Baseline, 9, 18, and 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Processing Speed/Attention | Standardized neuropsychological tests of processing speed and attention. Multiple measures will be aggregated into a composite index by scaling measures to common (z) metric, reverse coding relevant items, and computing their average to provide a single composite score for this outcome. | Baseline and 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaun M Eack, Ph.D. | University of Pittsburgh | Principal Investigator |
| Nancy J Minshew, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
Data will be shared through the National Database for Autism Research
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Final data will be deposited to NDAR upon study completion.
Access will be available to qualified investigators and institutions who are eligible for access to NDAR.
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| Enriched Supportive Therapy | Behavioral | 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. |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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