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NCT Number: NCT03583684

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

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).

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Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Pivotal Response Treatment

Primary outcomes

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

    Time frame: Baseline, 16 Weeks

Secondary outcomes

  1. Change on MacArthur-Bates Communication Development Inventory (CDI)

    Time frame: Baseline, 16 Weeks

Other outcomes

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

    Time frame: Baseline, 16 Weeks

  2. Change on Mullen Scales of Early Learning

    Time frame: Baseline, 16 Weeks

  3. Change on Vineland Adaptive Behaviors Scales, 3rd Edition

    Time frame: Baseline, 16 Weeks

  4. Change on Clinical Global Impressions Scale (CGI)

    Time frame: Baseline, 16 Weeks

  5. Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment

    Time frame: Baseline, 16 Weeks

  6. Change on Parent Stress Index (PSI)

    Time frame: Baseline, 16 Weeks

  7. Change on Family Empowerment Scale (FES)

    Time frame: Baseline, 16 Weeks

  8. Change on General Self Efficacy Scale (GSES)

    Time frame: Baseline, 16 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Estefania Millan, MA

CONTACT

[email protected]

(650) 736-1235

John Hegarty, PhD

CONTACT

[email protected]

(650) 736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: PRT-I

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2018
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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