Back to resultsPRT for Adolescents With High Functioning Autism
Primary Purpose
Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRT for Adolescents
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorder, PRT, Pivotal Response Treatment, Autism intervention, Social skills, Adolescents
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs Intelligence Quotient (IQ): Participants with a Full Scale IQ > 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) Right-handed No metal in their body/unremovable metal on their body (i.e., braces) First language is English Must live in the San Francisco Bay Area Able and willing to receive intervention weekly for 9 weeks Adolescent is interested in improving their social skills MRI Compatibility: No major contraindication for MRI. Diagnosis of ASD using ADOS-2 and ADI-R. No evidence of a genetic, metabolic, or infectious etiology for their autism. Primary diagnosis of ASD No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period. Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation. Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures) No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period. Exclusion Criteria: History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age < 34 weeks Left-handed Braces or any metal in their body
Sites / Locations
- Stanford Research Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PRT Treatment Group
Delayed Treatment Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc) of the mesolimbic reward system. For the PRT (i.e., intervention) group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the NAc as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.
Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions
The Structured Laboratory Observations (SLO) of child-assessor interactions is a common behavioral measure of each participant's social communicative interactions assessed in a laboratory setting. The metric used to characterize the SLO is an overall percentage of appropriate social responsiveness. Change in baseline SLO will be computed by subtracting Post- from Pre-training percentage of appropriate social responsiveness for each participant in the PRT group.
Secondary Outcome Measures
Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)
The Brief Observation of Social Communication Change (BOSCC) is a clinical instrument developed to measure longitudinal and/or training-related changes in social communication abilities in children with autism spectrum disorder. The metric used to characterize the BOSCC is the Social Communication subscale. Change in the Social Communication subscale will be computed for each participant in the PRT group by subtracting Post- from Pre-training Social Communication subscale scores.
(Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the temporoparietal junction (TPJ) an important brain system for theory-of-mind processing. For the PRT group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the TPJ as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.
Association between change in target engagement and change in clinical benefit (STS and NAc)
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc). Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and NAc as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-NAc connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
Association between change in target engagement and change in clinical benefit (STS and TPJ)
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and TPJ as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-TPJ connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
Group differences in the association between change in target engagement and clinical benefit (STS and NAc)
Target engagement consists of brain connectivity between voice selective STS and the NAc. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-NAc connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-TPJ connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987761
Brief Title
PRT for Adolescents With High Functioning Autism
Official Title
Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability, Child Development, Behavior, Child, Behavior, Social
Keywords
Autism, Autism Spectrum Disorder, PRT, Pivotal Response Treatment, Autism intervention, Social skills, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRT Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PRT for Adolescents
Intervention Description
Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.
Primary Outcome Measure Information:
Title
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
Description
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc) of the mesolimbic reward system. For the PRT (i.e., intervention) group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the NAc as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions
Description
The Structured Laboratory Observations (SLO) of child-assessor interactions is a common behavioral measure of each participant's social communicative interactions assessed in a laboratory setting. The metric used to characterize the SLO is an overall percentage of appropriate social responsiveness. Change in baseline SLO will be computed by subtracting Post- from Pre-training percentage of appropriate social responsiveness for each participant in the PRT group.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Secondary Outcome Measure Information:
Title
Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)
Description
The Brief Observation of Social Communication Change (BOSCC) is a clinical instrument developed to measure longitudinal and/or training-related changes in social communication abilities in children with autism spectrum disorder. The metric used to characterize the BOSCC is the Social Communication subscale. Change in the Social Communication subscale will be computed for each participant in the PRT group by subtracting Post- from Pre-training Social Communication subscale scores.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
(Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
Description
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the temporoparietal junction (TPJ) an important brain system for theory-of-mind processing. For the PRT group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the TPJ as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
Association between change in target engagement and change in clinical benefit (STS and NAc)
Description
Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc). Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and NAc as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-NAc connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
Association between change in target engagement and change in clinical benefit (STS and TPJ)
Description
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and TPJ as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-TPJ connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
Group differences in the association between change in target engagement and clinical benefit (STS and NAc)
Description
Target engagement consists of brain connectivity between voice selective STS and the NAc. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-NAc connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Title
Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)
Description
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-TPJ connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
Time Frame
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs
Intelligence Quotient (IQ): Participants with a Full Scale IQ > 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
Right-handed
No metal in their body/unremovable metal on their body (i.e., braces)
First language is English
Must live in the San Francisco Bay Area
Able and willing to receive intervention weekly for 9 weeks
Adolescent is interested in improving their social skills
MRI Compatibility: No major contraindication for MRI.
Diagnosis of ASD using ADOS-2 and ADI-R.
No evidence of a genetic, metabolic, or infectious etiology for their autism.
Primary diagnosis of ASD
No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation.
Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)
No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
Exclusion Criteria:
History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age < 34 weeks
Left-handed
Braces or any metal in their body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dani A Abrams, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Research Park
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Team
Phone
650-485-3149
Email
braindevelopment@stanford.edu
First Name & Middle Initial & Last Name & Degree
Lynn Koegel, Ph.D.
Email
lynnk@stanford.edu
First Name & Middle Initial & Last Name & Degree
Daniel A Abrams, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PRT for Adolescents With High Functioning Autism
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