Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Autism Spectrum Disorder Clinical Trial

— PRT-I  

Official title:

Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583684
• Other study ID #: IRB-46131
• Secondary ID: 1R21DC016089-01A
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: Estefania Millan, MA
• Phone: (650) 736-1235
• Email: mmillan2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
• Outpatients between 2.0 and 4.11 years of age of either gender,
• Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
• Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) [at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4],
• Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
• Stable treatment [Applied Behavior Analysis (ABA), Floortime, or other interventions], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
• No more than 60 minutes of 1:1 speech therapy per week,
• The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
• The availability of at least one parent who can consistently participate in the training sessions and related activities, and
• Successful completion of baseline brain scan.

Exclusion Criteria:

• Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
• Genetic abnormality (e.g., Fragile X)
• Presence of active medical problem (e.g., unstable seizure disorder),
• Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
• Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
• Previous adequate Pivotal Response Treatment (PRT) trial.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Pivotal Response Treatment Program (PRT-P)
The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on Preschool Language Scale, 5th Edition (PLS-5)		Baseline, 16 Weeks
Other	Change on Mullen Scales of Early Learning		Baseline, 16 Weeks
Other	Change on Vineland Adaptive Behaviors Scales, 3rd Edition		Baseline, 16 Weeks
Other	Change on Clinical Global Impressions Scale (CGI)		Baseline, 16 Weeks
Other	Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment		Baseline, 16 Weeks
Other	Change on Parent Stress Index (PSI)		Baseline, 16 Weeks
Other	Change on Family Empowerment Scale (FES)		Baseline, 16 Weeks
Other	Change on General Self Efficacy Scale (GSES)		Baseline, 16 Weeks
Primary	Change in Number of Child Utterances During a Structured Lab Observation (SLO)		Baseline, 16 Weeks
Secondary	Change on MacArthur-Bates Communication Development Inventory (CDI)		Baseline, 16 Weeks