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Behavioural Intervention
Pivotal Response Treatment for Autism
N/A
Recruiting
Led By Dani A Abrams, Ph.D.
Research Sponsored by Stanford 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 pre-treatment baseline, and between 11 to 13 weeks post-baseline
Awards & highlights
Study Summary
This trial studied how PRT treatment affects teens with ASD, looking at behavior, social skills, and brain changes.
Who is the study for?
This trial is for right-handed, English-speaking adolescents with high-functioning autism in the San Francisco Bay Area. They must have an IQ over 80 and be stable on current treatments with no metal in their body. Participants should want to improve social skills and have scored low on specific social target areas.Check my eligibility
What is being tested?
The study tests Pivotal Response Treatment (PRT) for Adolescents, focusing on enhancing behavioral and social functions. It also examines changes in brain activity related to this treatment using MRI scans over a period of 9 weeks.See study design
What are the potential side effects?
Since PRT is a behavioral intervention, it does not involve medication or medical procedures that typically cause side effects. However, participants may experience fatigue or stress from the intensity of therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment baseline, and between 11 to 13 weeks post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment baseline, and between 11 to 13 weeks post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions
Secondary outcome measures
(Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
Association between change in target engagement and change in clinical benefit (STS and NAc)
Association between change in target engagement and change in clinical benefit (STS and TPJ)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PRT Treatment GroupExperimental Treatment1 Intervention
After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. Participants in the PRT Treatment Group will complete an 9-week intervention, PRT for Adolescents, to improve the adolescent's social skills. Following the completion of the 9-week intervention, participants will be asked to complete a second MRI brain imaging session, followed by post-measure appointments in order to assess immediate effects of the intervention.
Group II: Delayed Treatment GroupExperimental Treatment1 Intervention
After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. After 9-weeks without any intervention, participants in the Delayed Treatment Group will be asked to complete a second MRI brain imaging session, followed by post-measure appointments, and will then receive the PRT intervention at the end of the study.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,274 Total Patients Enrolled
1 Trials studying Social Behavior
Dani A Abrams, Ph.D.Principal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with high-functioning autism.I want to get better at socializing.I have never had a serious head injury, neurological illness, was not born under 4 lb or before 34 weeks, and I'm not claustrophobic.I can commit to weekly treatments for 9 weeks.My autism is not caused by genetic, metabolic, or infectious factors.My primary diagnosis is Autism Spectrum Disorder.My current treatment for my condition has been stable for at least 1 month with no changes expected.
Research Study Groups:
This trial has the following groups:- Group 1: PRT Treatment Group
- Group 2: Delayed Treatment Group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does eligibility for this medical trial extend to individuals under forty years of age?
"This clinical trial is admitting children between 11 and 13 years of age."
Answered by AI
Are there still available openings to take part in this experiment?
"According to the clinicaltrials.gov page, this medical experiment is no longer accepting applicants. Initially posted on September 1st 2023 and last revised on August 3rd 2023, there are yet 435 other trials actively recruiting patients at present."
Answered by AI
Who is eligible to be a part of this experiment?
"Patients aged 11 to 13 with an autism spectrum disorder diagnosis are eligible for this medical trial, which is looking to recruit a total of 76 participants."
Answered by AI
What positive results are expected from this research?
"This clinical trial will be measured over pre-treatment baselines and 11 to 13 weeks post-baseline. It seeks to assess changes in structured laboratory observations (SLO) of child-assessor interactions. The secondary goals include investigating the brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ). Moreover, this study will explore the relationship between change in target engagement and change in clinical benefit through STS/NAc or STS/TPJ connections using generalised psychophysiological interaction models as well as Pearson's Correlation for effect size determination."
Answered by AI
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