Pivotal Response Treatment Package for Young Children With Autism (PRT-P)

Stanford University

Status

Completed

Conditions

Autism Spectrum Disorder (ASD)

Autism

Treatments

Behavioral: Pivotal Response Treatment Package (PRT-P)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02037022

IRB-28314

R21DC013689 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism.

Full description

Researchers at the Stanford University School of Medicine are seeking participants for a research study examining the effectiveness of a pivotal response treatment package (PRT-P) in targeting language skills in young children with autism. Research has demonstrated that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements in the core symptoms of autism. Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement PRT with in-home, therapist-implemented treatment. To determine the effectiveness of a PRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid clinicians in providing better care for children with autism.

Enrollment

48 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview- Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), and expert clinical opinion
Males and females in good medical health 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: Standard score at least 1 Standard Deviation below average for expressive language ability
Stable treatment, speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation
No more than 60 minutes of individual 1:1 speech therapy per week
Availability of at least one parent who can consistently participate in parent training and research measures
Parents intend on continuing Pivotal Response Treatment Package (PRT-P) for a minimum of 12 weeks
Parents must be 18 years of age or older

Exclusion criteria

Current or lifetime diagnosis of severe psychiatric disorder, such as bipolar disorder
Receiving in-home Applied Behavior Analysis (ABA) of 10 hours or more
A genetic abnormality, such as Fragile X
Presence of active medical problem, such as unstable seizure disorder or heart disease
Previous adequate PRT trial
Participants living more than 50 miles from Stanford University
At least one room of the house must be available to be dedicated to treatment during session times
There must be no serious health and safety risks present in the home environment
The research team has the right to refuse to perform sessions in-home even if the criteria above are met