Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorStanford University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
BehavioralPivotal Response Treatment in autism center.
Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)
BehavioralPivotal Response Treatment in home environment.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)Experimental treatment 1 intervention
Group B: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)Experimental treatment 1 intervention
Group C: Treatment As Usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
Time frame
Baseline,16 Weeks.Secondary outcomes
1
Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
Time frame
Baseline,16 Weeks.2
Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
Time frame
Baseline,16 Weeks.3
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores
Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities.
Time frame
Baseline,16 Weeks.4
Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores
Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
Time frame
Baseline,16 Weeks.Other outcomes
1
Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores
Time frame
Baseline,16 Weeks.2
Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores
Time frame
Baseline,16 Weeks.3
Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores
Time frame
Baseline,16 Weeks.4
Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores
Time frame
Baseline,16 Weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Anonymous Donor
Collaborator
Source ClinicalTrials.gov