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Behavioural Intervention
Pivotal Response Treatment for Autism
Palo Alto, CA
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
No Placebo-Only Group
Summary
This trial studied how PRT treatment affects teens with ASD, looking at behavior, social skills, and brain changes.
See full description
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
(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 study objectives
(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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Find a Location
Closest Location:Stanford Research Park· Palo Alto, CA· 2106 miles
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,525 Previous Clinical Trials
17,427,818 Total Patients Enrolled
37 Trials studying Autism Spectrum Disorder
3,801 Patients Enrolled for Autism Spectrum Disorder
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: Delayed Treatment Group
- Group 2: PRT 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.