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

Primary Purpose

Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Enhancement Therapy
Enriched Supportive Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Autism Spectrum Disorder, Asperger's Syndrome, Pervasive Developmental Disorder, Cognition, Social Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Enriched Supportive Therapy, Therapy, Psychotherapy

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Enhancement Therapy

Enriched Supportive Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2017
Last Updated
February 15, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03170453
Brief Title
Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Acronym
PerspectivesII
Official Title
Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Autism Spectrum Disorder, Asperger Syndrome, Pervasive Developmental Disorder
Keywords
Autism, Autism Spectrum Disorder, Asperger's Syndrome, Pervasive Developmental Disorder, Cognition, Social Cognition, Psychosocial Treatment, Cognitive Enhancement Therapy, Enriched Supportive Therapy, Therapy, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Enhancement Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Enriched Supportive Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Enhancement Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enriched Supportive Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Neurocognition
Description
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.
Time Frame
Pre-treatment, 9, 18, and 30 months
Title
Change in Social cognition
Description
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.
Time Frame
Baseline, 9, 18, and 30 months
Secondary Outcome Measure Information:
Title
Change in Functional outcome
Description
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.
Time Frame
Baseline, 9, 18, and 30 months
Other Pre-specified Outcome Measures:
Title
Change in Processing Speed/Attention
Description
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.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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) that is untreated Comorbid personality disorder History of disruptive or violent behavior Any magnetic resonance imaging contraindications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun M Eack, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy J Minshew, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared through the National Database for Autism Research
IPD Sharing Time Frame
Final data will be deposited to NDAR upon study completion.
IPD Sharing Access Criteria
Access will be available to qualified investigators and institutions who are eligible for access to NDAR.

Learn more about this trial

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

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