Pivotal Response Treatment Package for Young Children With Autism

Autism Clinical Trial

— PRT-P  

Official title:

Pivotal Response Treatment Package for Young Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037022
• Other study ID #: IRB-28314
• Secondary ID: R21DC013689
• Status: Completed
• Phase: N/A
• Start date: December 4, 2013
• Est. completion date: July 28, 2017

Study information

• Verified date: February 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder

Intervention

Behavioral:
• Pivotal Response Treatment Package (PRT-P)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gengoux GW, Abrams DA, Schuck R, Millan ME, Libove R, Ardel CM, Phillips JM, Fox M, Frazier TW, Hardan AY. A Pivotal Response Treatment Package for Children With Autism Spectrum Disorder: An RCT. Pediatrics. 2019 Sep;144(3). pii: e20190178. doi: 10.1542/p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks		12 and 24 weeks
Secondary	Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 6, 12, and 24 weeks		6, 12 and 24 weeks
Secondary	Change from Baseline on the Parenting Stress Index (PSI) at 6, 12, and 24 weeks		6, 12, and 24 weeks
Secondary	Change from Baseline on the Family Empowerment Scale (FES) at 6, 12, and 24 weeks		6, 12, and 24 weeks
Secondary	Change from Baseline on the Clinical Global Impression Scale at 6, 12, and 24 weeks		6, 12, and 24 weeks
Secondary	Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks		12, and 24 weeks