Intensive Center-Based Pivotal Response Treatment (PRT-C) for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism Spectrum Disorder+3 More
Intensive Center-Based Pivotal Response Treatment (PRT-C) - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if a treatment called "pivotal response training" can help improve social communication skills in children with autism spectrum disorder.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders
  • Autism, Early Infantile

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Baseline and Week 12

Baseline and Week 12
Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks
Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks
Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks

Trial Safety

Trial Design

2 Treatment Groups

Delayed Treatment Group (DTG)
1 of 2
Intensive Center-Based Pivotal Response Treatment (PRT-C)
1 of 2
Active Control
Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Intensive Center-Based Pivotal Response Treatment (PRT-C) · No Placebo Group · N/A

Intensive Center-Based Pivotal Response Treatment (PRT-C)
Behavioral
Experimental Group · 1 Intervention: Intensive Center-Based Pivotal Response Treatment (PRT-C) · Intervention Types: Behavioral
Delayed Treatment Group (DTG)NoIntervention Group · 1 Intervention: Delayed Treatment Group (DTG) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and week 12

Who is running the clinical trial?

John & Marcia Goldman FoundationUNKNOWN
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
75 Patients Enrolled for Autism Spectrum Disorder
Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,679,124 Total Patients Enrolled
27 Trials studying Autism Spectrum Disorder
2,377 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
8 Previous Clinical Trials
407 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
359 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 2 and 3 years and 11 months.
Parent training and research measures must be available to the participant.
You are able to participate in the testing procedures to the extent that valid standard scores can be obtained.
You have a developmental delay with a score below 85 on the MSEL or DP-4 composite score.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
< 18100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%