AutismNCT05987761
PRT for Adolescents With High Functioning Autism
A study testing PRT for Adolescents in people with Autism and Autism Spectrum Disorder High-Functioning, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability
- What is being tested?
- PRT for Adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford Research Park
Palo Alto, California, 94304
Study Team, 650-485-3149, braindevelopment@stanford.edu
Lynn Koegel, Ph.D., lynnk@stanford.edu
About this study
Official title: Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
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).
- Conditions
- Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability, Child Development, Behavior, Child, Behavior, Social
- Being tested
- PRT for Adolescents
- Keywords
- Autism, Autism Spectrum Disorder, PRT, Pivotal Response Treatment, Autism intervention, Social skills, Adolescents
- Medical subject headings
- Autistic Disorder, Developmental Disabilities, Child Behavior, Social Behavior, Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT for AdolescentsBehavioural
Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.
| Study group | Role | What they receive |
|---|---|---|
| PRT Treatment Group | Experimental | 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. Receives: Behavioral: PRT for Adolescents |
| Delayed Treatment Group | Experimental | 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. Receives: Behavioral: PRT for Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Secondary outcomes (6)
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
(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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
Measured: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Abrams, Stanford University
- Investigators
- Dani A Abrams, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987761
- Sponsor's protocol ID
- 60502
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
- ClinicalTrials.gov ID
- NCT05987761
- Acronym / sponsor ID
- 60502
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRT Treatment Group | Experimental | Behavioral: PRT for AdolescentsAfter 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. |
| Delayed Treatment Group | Experimental | Behavioral: PRT for AdolescentsAfter 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT for AdolescentsClinician-led 70-minute PRT sessions targeting social skills once per week at Stanford. | Behavioural | Delayed Treatment Group, PRT Treatment Group |
Primary outcome
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
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.
6 secondary outcomes
Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
(Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Association between change in target engagement and change in clinical benefit (STS and NAc)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Association between change in target engagement and change in clinical benefit (STS and TPJ)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Group differences in the association between change in target engagement and clinical benefit (STS and NAc)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)
Time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dani A Abrams, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRT for Adolescents in people with Autism and Autism Spectrum Disorder High-Functioning, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc) (time frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.