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

NCT ID: NCT03583684

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-07
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pivotal Response Treatment Program (PRT-P)

Intervention Type: 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.

Delayed Treatment Group (DTG)

Child continues stable treatments as usual in the community.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Pivotal Response Treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hardan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Estefania Millan, MA

Role: CONTACT

Phone: (650) 736-1235

Email: mmillan2@stanford.edu

John Hegarty, PhD

Role: CONTACT

Phone: (650) 736-1235

Email: hegartyj@stanford.edu

Facility Contacts

Estefania Millan, MA

Role: primary

Robin Libove, BS

Role: backup

Other Identifiers

1R21DC016089-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-46131

Identifier Type: -

Identifier Source: org_study_id