Clinical trial NCT04899544: Trial of Center-Based Vs. In-Home Pivotal Response Treatment (PRT) in Autism
Official title: Randomized Controlled Trial of Center-Based Vs. In-Home Pivotal Response Treatment (PRT) in Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
ASD
Keywords: pivotal response treatment
PRT
center based
social and communication
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Anonymous Donor
First posted: 2021-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO).
timeFrame: Baseline,16 Weeks.
Secondary outcomes:
measure: Change on MacArthur-Bates Communication Development Inventory (CDI) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores
timeFrame: Baseline,16 Weeks.
measure: Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment.
timeFrame: Baseline,16 Weeks.
measure: Change on the Clinical Global Impressions (CGI) Scale.
timeFrame: Baseline,16 Weeks.
Other outcomes:
measure: Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores
timeFrame: Baseline,16 Weeks.
measure: Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores
timeFrame: Baseline,16 Weeks.
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y. Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: