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Behavioral Intervention

CBT for Autism

N/A

Waitlist Available

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (week 0) at endpoint (week 16)

Awards & highlights

Study Summary

This trial will compare CBT to PST in children with ASD and anxiety, using fMRI to look at changes in the brain.

Eligible Conditions

Autism Spectrum Disorder
Anxiety
Autism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (week 0) at endpoint (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (week 0) at endpoint (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (week 0) at endpoint (week 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Global Impression - Improvement (CGI-I) scale

Pediatric Anxiety Rating Scale (PARS)

blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.

Secondary outcome measures

blood oxygenation level dependent signal (BOLD) during emotional face perception task

Other outcome measures

blood oxygenation level dependent signal (BOLD) during perception of biological versus scrambled motion.

Side effects data

From 2009 Phase 2 & 3 trial • 162 Patients • NCT00248612

13%

suicidal ideation

vertigo

agitation/restlessness

nausea

depression

anxiety

profuse sweating

100%

80%

60%

40%

20%

Study treatment Arm

Placebo & CBT

Venlafaxine & CBT

Venlafaxine & PMR

Placebo & PMR

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive-Behavioral Therapy (CBT)Experimental Treatment1 Intervention

CBT is dedicated to developing coping skills for managing anxiety such as emotion regulation and cognitive reappraisal. Children first learn and practice these skills during one-on-one, weekly sessions with experienced therapists and then apply this skills to navigate anxiety-producing situations as home, school and community. A key component of CBT involves exposure exercises, facing feared situations repeatedly while using the emotion regulation skills and remaining in the situations until anxiety is substantially reduced or become easy to tolerate. The feared situations are ordered from least to most distressing during therapy sessions in collaboration with the child and their parent. The unique combination of anxiety and ASD symptoms of social impairment and restricted/repetitive behavior is addressed in dedicated child and parent modules.

Group II: Psychoeducation and Supportive Therapy (PST)Active Control1 Intervention

Psychoeducation and Supportive Therapy includes learning about and discussing issues of diagnosis, treatment and educational services can also benefit children with ASD and their families. Each PST session starts with a review of events of the past week and include queries of topics such as school, interests, and family with an overarching goal of enhancing subjective well-being. The clinician, through the use of supportive, empathic and nondirective actions, will provide the participant with a "sounding-board" so that they can voice their concerns regarding specific problems that may require discussion and assistance. A major objective is to provide a clinical contact that enables participants to think through and discuss their concerns with a sympathetic adult. Subjects randomized to PST will be offered CBT after completion of the endpoint assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT

2013

Completed Phase 3

~4220

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