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Behavioral Intervention
Executive Function Group Therapy for Autism Spectrum Disorder
N/A
Waitlist Available
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intact or corrected hearing and vision.
14-18 years of age inclusive
Must not have
To preserve the integrity of the neuroimaging data, participants will be excluded if they have a history of neurological disorder, such as an established epilepsy diagnosis, significant brain trauma, hydrocephalus, central nervous system infection, or stroke.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a cognitive behavioral intervention can help improve flexibility in ASD by looking at changes in learning and associated neural activation.
Who is the study for?
This trial is for adolescents aged 14-18 with Autism Spectrum Disorder who have an IQ over 80 and can communicate effectively in English. They must meet specific criteria on autism diagnostic tools and have normal or corrected hearing and vision. Those with metal implants, braces, pregnancy, significant neurological issues, or conditions affecting study participation are excluded.
What is being tested?
The trial tests if executive function group therapy can improve learning flexibility in teens with ASD using brain scans (m-fMRI) to observe changes. It's a long-term study where participants are assessed three times over eight months to see how the therapy affects their brain activity and behavior.
What are the potential side effects?
Since this is a behavioral intervention involving cognitive exercises rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience fatigue or discomfort from repetitive tasks or the MRI procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hearing and vision are normal or corrected to normal.
Select...
I am between 14 and 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a history of major brain conditions like epilepsy, severe injury, infections, or stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Executive Function Challenge Task (EFCT) Scores
Change in Neural Response During Prototype Learning Task Outcomes
Secondary study objectives
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores
Other study objectives
Change in AIR-SDS Scores
Change in ASC - ASD Scores
Change in BDI-II Scores
+8 moreAwards & 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: Executive function group therapyExperimental Treatment1 Intervention
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,054 Previous Clinical Trials
2,731,570 Total Patients Enrolled
36 Trials studying Autism Spectrum Disorder
9,987 Patients Enrolled for Autism Spectrum Disorder
Children's National Research InstituteLead Sponsor
221 Previous Clinical Trials
258,306 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
292 Patients Enrolled for Autism Spectrum Disorder
Georgetown UniversityOTHER
348 Previous Clinical Trials
137,238 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
216 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of major brain conditions like epilepsy, severe injury, infections, or stroke.My hearing and vision are normal or corrected to normal.I am between 14 and 18 years old.I (or my child) can speak and understand English well enough for therapy and forms.
Research Study Groups:
This trial has the following groups:- Group 1: Executive function group therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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