Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder

Conditions
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Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder

Intervention / Treatment
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* Behavioral: Cognitive Enhancement Therapy
* Behavioral: Enriched Supportive Therapy


Participation Criteria
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Eligibility Criteria
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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) that is untreated Comorbid personality disorder History of disruptive or violent behavior Any magnetic resonance imaging contraindications

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Enhancement Therapy<br>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<br>* 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.<br>|
| Active Comparator: Enriched Supportive Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Autism Spectrum Disorder, Asperger's Syndrome, Pervasive Developmental Disorder, Cognition, Social Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Enriched Supportive Therapy, Therapy, Psychotherapy