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Recruiting NCT04899544

Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

No phase Interventional Autism Autism Spectrum Disorder ASD

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: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C), Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H).
Who it may be relevant to
Registry conditions: Autism, Autism Spectrum Disorder, ASD. 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 Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism

Overview

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

Interventions

  • Behavioral Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
    Pivotal Response Treatment in autism center.
  • Behavioral Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
    Pivotal Response Treatment in home environment.

Primary outcome measures

  • Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). [Time frame: Baseline,16 Weeks.]
Secondary outcome measures (6)
  • Change on MacArthur-Bates Communication Development Inventory (CDI) Scores [Time frame: Baseline,16 Weeks.]
  • Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores [Time frame: Baseline,16 Weeks.]
  • Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores [Time frame: Baseline,16 Weeks.]
  • Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores [Time frame: Baseline,16 Weeks.]
  • Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment. [Time frame: Baseline,16 Weeks.]
  • Change on the Clinical Global Impressions (CGI) Scale. [Time frame: Baseline,16 Weeks.]

Eligibility criteria

Inclusion criteria

  • Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;
  • Boys and girls between 2.0 and 5.11 years;
  • Ability 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): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;
  • Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;
  • No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);
  • No more than 60 minutes of individual 1:1 speech therapy per week;
  • Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.

Exclusion criteria

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
  • Receiving ABA of 15 hours or more;
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
  • Previous adequate Pivotal Response Treatment (PRT) trial;
  • Participants living more than 30 miles from Stanford University;
  • Child's primary language other than English.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University School of Medicine — Stanford

Identifiers

NCT: NCT04899544 · IRB-61427

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗