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Cognitive-Behavioral Therapy for Autism

N/A

Waitlist Available

Led By Denis Sukhodolsky, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

IQ between 55 and 85

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether modified cognitive-behavioral therapy can help reduce disruptive behavior in children with autism spectrum disorders and intellectual disability.

Who is the study for?

This trial is for children with Autism Spectrum Disorder and an IQ between 55 and 85 who show disruptive behaviors like irritability. They must be able to complete study assessments and fMRI scans, either un-medicated or on a stable medication regimen. Children with other medical or psychiatric conditions needing different treatments cannot participate.

What is being tested?

The study tests Cognitive-Behavioral Therapy (CBT) tailored for children with ASD to manage irritability and disruptive behavior. It includes simpler activities while keeping CBT's core principles intact. Participants will also undergo fMRI scans before and after therapy to look for changes in brain activity related to social perception and emotion regulation.

What are the potential side effects?

While CBT itself does not have direct side effects, the process can sometimes cause temporary increases in distress as new coping strategies are learned. The fMRI procedure is non-invasive but may be uncomfortable due to the need to stay still inside the scanner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My IQ is between 55 and 85.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly - up to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly - up to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly - up to 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aberrant Behavior Checklist - Irritability Scale (ABC-I)

Modified Overt Aggression Scale (MOAS)

Secondary study objectives

Home Situations Questionnaire (HSQ)

Other study objectives

BOLD signal change during the emotional face perception task completed during fMRI scan

BOLD signal change in the conditions of the emotion-induction GoNoGo task complete during fMRI scan

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489

24%

Nausea

12%

Headache

12%

Cold

10%

Dry Mouth

10%

Fatigue

Gastrointestinal Issues

Muscle Aches

Vomiting

Serious Suicidal Ideation

Diarrhea

Constipation

Stomach Virus

Changes to Vision

Loose Stool

Increased Irritability

Sedation

Stomach Pain

Increased Bowel Movements

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Naltrexone + Supportive Counseling

Naltrexone + CBT (Prolonged Exposure Therapy)

Placebo + CBT (Prolonged Exposure Therapy)

Placebo + Supportive Counseling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cognitive-Behavioral TherapyExperimental Treatment2 Interventions

CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive-Behavioral Therapy

2000

Completed Phase 4

~1820

0 / 1Eligibility criteria met