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

NCT03170453 | Completed

• 2 other identifiers: STUDY19080150R01MH106450
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Functional outcome

  Baseline, 9, 18, and 30 months

Other Outcomes (1)

• Change in Processing Speed/Attention

  Baseline and 3 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

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.

Cognitive Enhancement Therapy

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.

Enriched Supportive Therapy

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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) that is untreated
• Comorbid personality disorder
• History of disruptive or violent behavior
• Any magnetic resonance imaging contraindications

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shaun M Eack, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Nancy J Minshew, Ph.D.

  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: February 27, 2017
• First Posted: May 31, 2017
• Study Start: June 1, 2015
• Primary Completion: May 4, 2022
• Study Completion: December 31, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final data will be deposited to NDAR upon study completion.
• Access Criteria: Access will be available to qualified investigators and institutions who are eligible for access to NDAR.

Locations

US (1)