Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder (Perspectives)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Autistic Disorder; Autism Spectrum Disorder; Asperger's Syndrome; Pervasive Developmental Disorder	Behavioral: Cognitive Enhancement Therapy; Behavioral: Enriched Supportive Therapy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Actual Study Start Date :	August 2010
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	June 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Neurocognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
   Composite measure of neuropsychological tests designed to assess neurocognitive function
2. Social cognition [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
   Composite measure of performance-based and interview tests designed to assess social-cognitive function

Secondary Outcome Measures :

1. Functional outcome [ Time Frame: Pre-treatment, 9, 18, and 30 months ]
   Functional Assessment Battery (Social, Role, Vocational)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Pittsburgh

National Institute of Mental Health (NIMH)

Autism Speaks

United States Department of Defense

Pennsylvania Department of Health

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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:	Shaun M. Eack, Professor of Social Work and Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00902798 History of Changes
Other Study ID Numbers:	MH085851; R33MH085851 ( U.S. NIH Grant/Contract ); R21MH085851 ( U.S. NIH Grant/Contract ); AR100344 ( Other Grant/Funding Number: Department of Defense ); 05381 ( Other Grant/Funding Number: Autism Speaks ); 2008NF-Autism ( Other Grant/Funding Number: Pennsylvania Department of Health ); ARI2014 ( Other Grant/Funding Number: Autism Research Institute )
First Posted:	May 15, 2009
Last Update Posted:	November 30, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Data will be shared through the National Database for Autism Research

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Shaun M. Eack, University of Pittsburgh:

Autism; Autism Spectrum Disorders; Asperger's Syndrome; 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; Developmental Disabilities	Asperger Syndrome; Pathologic Processes; Neurodevelopmental Disorders; Mental Disorders