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

NCT ID: NCT03170453

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome; Pervasive Developmental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Cognitive Enhancement Therapy

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Enriched Supportive Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Shaun M. Eack

Professor of Social Work and Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun M Eack, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Nancy J Minshew, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R01MH106450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19080150

Identifier Type: -

Identifier Source: org_study_id