NCT00902798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

5.7 years

First QC Date

May 13, 2009

Last Update Submit

April 10, 2020

Conditions

Keywords

AutismAutism Spectrum DisordersAsperger's SyndromePervasive Developmental DisorderCognitionSocial CognitionPsychosocial TreatmentCognitive Enhancement TherapyEnriched Supportive TherapyTherapyPsychotherapy

Outcome Measures

Primary Outcomes (2)

  • Neurocognition

    Composite measure of neuropsychological tests designed to assess neurocognitive function

    Pre-treatment, 9, 18, and 30 months

  • Social cognition

    Composite measure of performance-based and interview tests designed to assess social-cognitive function

    Pre-treatment, 9, 18, and 30 months

Secondary Outcomes (1)

  • Functional outcome

    Pre-treatment, 9, 18, and 30 months

Study Arms (2)

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

Behavioral: Cognitive Enhancement Therapy

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

Behavioral: Enriched Supportive Therapy

Interventions

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.

Cognitive Enhancement 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.

Enriched Supportive Therapy

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • 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. doi: 10.1001/archpsyc.61.9.866.

    PMID: 15351765BACKGROUND
  • Hogarty GE, Greenwald DP, Eack SM. Durability and mechanism of effects of cognitive enhancement therapy. Psychiatr Serv. 2006 Dec;57(12):1751-7. doi: 10.1176/ps.2006.57.12.1751.

    PMID: 17158490BACKGROUND
  • 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. doi: 10.1016/j.schres.2006.08.018. Epub 2006 Oct 19.

    PMID: 17055227BACKGROUND
  • Eack SM, Hogarty SS, Greenwald DP, Litschge MY, Porton SA, Mazefsky CA, Minshew NJ. Cognitive enhancement therapy for adult autism spectrum disorder: Results of an 18-month randomized clinical trial. Autism Res. 2018 Mar;11(3):519-530. doi: 10.1002/aur.1913. Epub 2017 Dec 29.

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum DisorderAsperger SyndromeChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Shaun M. Eack, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Nancy J. Minshew, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Social Work and Psychiatry

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

August 1, 2010

Primary Completion

April 1, 2016

Study Completion

June 1, 2017

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Data will be shared through the National Database for Autism Research

Locations