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Recruiting NCT06523387

Online Pivotal Response Treatment Training in Autism Spectrum Disorder

No phase Interventional Autism Spectrum Disorder Autism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pivotal Response Treatment Online (PRT-O) Course.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Autism. Basic parameters: 2 years — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Controlled Trial of an Online Pivotal Response Treatment Training in Autism Spectrum Disorder

Overview

This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.

Interventions

  • Behavioral Pivotal Response Treatment Online (PRT-O) Course
    Pivotal Response Treatment - Parent Training

Primary outcome measures

  • Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO) [Time frame: 6 Weeks and 12 Weeks]
  • Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO) [Time frame: 6 Weeks and 12 Weeks]
Secondary outcome measures (3)
  • Change from Baseline on the Clinical Global Impression Scales (CGI) [Time frame: 6 Weeks and 12 Weeks]
  • Change from Baseline on the Vineland Adaptive Behavior Scales -3 (VABS-3) Communication Domain [Time frame: 12 Weeks]
  • Change from Baseline on the MacArthur-Bates Communication Scales (CDI) [Time frame: 12 Weeks]

Eligibility criteria

Inclusion criteria

  • 2:0 to 5:11 years at the time of consent,
  • diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),
  • with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),
  • an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,
  • 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 (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

Exclusion criteria

  • Children who have a primary language other than English
  • parent or child diagnosed with severe psychiatric disorder or unstable medical problem
  • previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline
  • Receiving more than 15 hours of in home 1:1 ABA per week
  • living within 100 miles of Stanford University.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT06523387 · IRB-73856

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗