Functional magnetic resonance imaging (fMRI) for Autistic Disorder

Phase-Based Estimates
1
Effectiveness
1
Safety
Yale Child Study Center, New Haven, CT
Autistic Disorder+3 More
Functional magnetic resonance imaging (fMRI) - Other
Eligibility
< 18
All Sexes
Eligible conditions
Autistic Disorder

Study Summary

This study is evaluating whether cognitive-behavioral therapy can reduce disruptive behavior in children with autism spectrum disorders and intellectual disability.

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Eligible Conditions

  • Autistic Disorder
  • Idiocy
  • Autism Spectrum Disorder
  • Intellectual Disability
  • Autism, Early Infantile

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Functional magnetic resonance imaging (fMRI) will improve 2 primary outcomes, 1 secondary outcome, and 2 other outcomes in patients with Autistic Disorder. Measurement will happen over the course of endpoint (16 weeks).

Week 20
Aberrant Behavior Checklist - Irritability Scale (ABC-I)
Modified Overt Aggression Scale (MOAS)
endpoint (16 weeks)
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
Home Situations Questionnaire (HSQ)

Trial Safety

Trial Design

2 Treatment Groups

Control
Cognitive-Behavioral Therapy

This trial requires 6 total participants across 2 different treatment groups

This trial involves 2 different treatments. Functional Magnetic Resonance Imaging (fMRI) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Cognitive-Behavioral TherapyCBT 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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavioral Therapy
2000
Completed Phase 4
~1410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weekly - up to 20 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weekly - up to 20 weeks for reporting.

Closest Location

Yale Child Study Center - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
DSM-5 diagnosis of Autism Spectrum Disorder
Presence of disruptive behaviors such as irritability and anger outbursts
IQ between 55 and 85
ABC Irritability Scale score greater than or equal to 15
Un-medicated or on stable medication regimen
Able to complete all study assessment and fMRI procedures

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get autistic disorder a year in the United States?

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Approximately 25 cases per year are new cases of Asperger syndrome, and around 50 per year are new cases of Autistic disorder in the US. On average, 3.8 cases of Asperger syndrome are diagnosed per year in this population, and 4.1 cases of Autistic disorder are diagnosed per year for this population. These numbers seem to be consistent with the approximate rates of autism spectrum disorder in the general US population. There is a need for more study on the prevalence of autism spectrum disorder in the US population as this prevalence may be higher than previously thought.

Unverified Answer

What causes autistic disorder?

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No clear cause of autism exists, but some authors argue that autism spectrum disorder would not have been as special as it is without early intervention.\n

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Can autistic disorder be cured?

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No evidence exists that ASD can be cured, and no such cure has been suggested in the literature to date. ASDs are often associated with other conditions, so treatment is often recommended at a time when it is too late to influence the outcome of these other conditions, and treatment in the immediate aftermath of ASD diagnosis does not improve the child's social skills or quality of life. Further research is needed to determine which conditions are most strongly associated with ASD.

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What is autistic disorder?

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Many of the symptoms of Asperger syndrome and the features of PDD-NOS share some characteristics, in particular a high-functioning form in young children, an onset typically before 4 years, a preference for social over tactile stimulation and an unusual interest in non-verbal communication. The spectrum of spectrum may include autism-spectrum disorders as a subgroup. More information is needed on whether these conditions may be on the same spectrum, a spectrum of conditions or different conditions.

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What are the signs of autistic disorder?

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Patients usually complain of poor attention, difficulty with interpersonal skills and social interaction, and trouble with repetitive behaviors and other restrictive behaviors. Autistic parents may recognize signs of the disorder in the development of their children more often than is commonly recognized or reported. In addition, there are no accurate screening instruments to identify autistic children. At present, the best we can do is follow the child closely to identify the signs of autism. [Read more...

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What are common treatments for autistic disorder?

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There is little evidence to support the use of many common treatments for ASD, including psychoeducation, the use of special education programs, behavioral therapy, and behavioral, physical, and occupational therapy. There is no evidence that certain programs or treatments are more effective at preventing ASD than others; all programs appear to be equally effective in the long term. In the absence of high-quality evidence as to the effectiveness, tolerability, and safety of treatments for ASD, clinicians may choose to use a variety of evidence-based interventions, using the most effective available.

Unverified Answer

Does cognitive-behavioral therapy improve quality of life for those with autistic disorder?

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Data from a recent study is, to our knowledge, the first to explore the impact of CBT on AQoL in this population. We found significant and clinically meaningful improvements in AQoL scores for the CBT group. Further research is needed to fully understand the nature of these effects and to compare them to those reported for other treatments for ASD. The CBT process had profound effects on the families of individuals with ASD, both in how they perceived their child's AQoL and in their ability to cope with daily demands on their functioning.

Unverified Answer

Who should consider clinical trials for autistic disorder?

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Current available evidence suggests that most children, teenagers, and adults with ASD meet the criteria for clinical trial participation. It is crucial to find methods of recruiting and retaining children into clinical trials to test many proposed hypotheses. Further research should focus on development of tools for identifying the strengths of ASD.

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What are the common side effects of cognitive-behavioral therapy?

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Recent findings shows that CBT has no more than minimal side effects, even among very disturbed children. Although some of the effects are statistically important, they are of low clinical importance. Most parents do not report such effects on their own children. The positive effects of CBT should also be considered in their treatment.

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What is the average age someone gets autistic disorder?

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Individuals with ASD show no evidence that the average age diagnosed with ASD is earlier or later than other disorders like ADHD comorbidity, epilepsy, or psychosis. (See Autism Spectrum Disorders, P. 1296.

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How does cognitive-behavioral therapy work?

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This protocol of CBT for autism did not improve the treatment of autistic disorder and showed limited benefit for cognitive outcomes. Future studies utilizing this protocol can evaluate the most effective format for CBT in the treatment of autism. summary: Results from a recent clinical trial evaluated effectiveness of a computerized CBT program for people with autism.

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Have there been other clinical trials involving cognitive-behavioral therapy?

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All the research studies that have been done involve CPT. Cognitive-behavioral therapies have been used to help autistic children for decades, and they are also used for children who have ADHD. If there are any potential future clinical trials, we want to be notified so that we can help educate families.

Unverified Answer
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