Clinical trial NCT03170453: Confirmatory Efficacy Trial of Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Official title: Cognitive Enhancement Therapy for Adult Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-05-31
Enrollment: 86
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Neurocognition
timeFrame: Pre-treatment, 9, 18, and 30 months
measure: Change in Social cognition
timeFrame: Baseline, 9, 18, and 30 months
Secondary outcomes:
measure: Change in Functional outcome
timeFrame: Baseline, 9, 18, and 30 months
Other outcomes:
measure: Change in Processing Speed/Attention
timeFrame: Baseline and 3 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Shaun M Eack, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Nancy J Minshew, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: