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

NCT03583684 | Recruiting DMC

• 2 other identifiers: IRB-461311R21DC016089-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Autism Spectrum Disorder; Autism

Keywords

Pivotal Response Treatment; Imaging

Outcome Measures

Primary Outcomes (1)

• Change in Number of Child Utterances During a Structured Lab Observation (SLO)

  Baseline, 16 Weeks

Secondary Outcomes (1)

• Change on MacArthur-Bates Communication Development Inventory (CDI)

  Baseline, 16 Weeks

Other Outcomes (8)

• Change on Preschool Language Scale, 5th Edition (PLS-5)

  Baseline, 16 Weeks

• Change on Mullen Scales of Early Learning

  Baseline, 16 Weeks

• Change on Vineland Adaptive Behaviors Scales, 3rd Edition

  Baseline, 16 Weeks

Study Arms (2)

Pivotal Response Treatment Program (PRT-P)

EXPERIMENTAL

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.

Behavioral: Pivotal Response Treatment Program (PRT-P)

Delayed Treatment Group (DTG)

NO INTERVENTION

Child continues stable treatments as usual in the community.

Interventions

Pivotal Response Treatment Program (PRT-P) BEHAVIORAL

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.

Also known as: Pivotal Response Treatment

Pivotal Response Treatment Program (PRT-P)

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305-5719, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estefania Millan, MA

CONTACT

(650) 736-1235; mmillan2@stanford.edu

John Hegarty, PhD

CONTACT

(650) 736-1235; hegartyj@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 11, 2018
• Study Start: December 7, 2018
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)