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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder; Autism

• Registration Number: NCT03583684
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Study Start: 2018-12-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Number of Child Utterances During a Structured Lab Observation (SLO)	Baseline, 16 Weeks

Secondary Outcome Measures

Name	Time	Method
Change on MacArthur-Bates Communication Development Inventory (CDI)	Baseline, 16 Weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States