Pivotal Response Treatment Package for Young Children With Autism

NCT02037022 | Completed

• 2 other identifiers: IRB-28314R21DC013689
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder (ASD); Autism

Keywords

Autism Spectrum Disorder (ASD); Autism

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in communication during parent-child and clinician-child interactions at 6, 12, and 24 weeks

  6, 12 and 24 weeks

Secondary Outcomes (10)

• Change from Baseline on the Preschool Language Scale, 5th Edition (PLS-5) at 12, and 24 weeks

  12 and 24 weeks

• Change from Baseline on the Sensory Profile Questionnaire at 6, 12, and 24 weeks

  6, 12 and 24 weeks

• Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks

  6, 12 and 24 weeks

• Change from Baseline on the MacArthur-Bates Communication Development Inventory at 6, 12, and 24 weeks

  6, 12 and 24 weeks

• Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 6, 12, and 24 weeks

  6, 12 and 24 weeks

Study Arms (2)

Pivotal Response Treatment Package

EXPERIMENTAL

Pivotal Response Treatment Package (PRT-P)

Behavioral: Pivotal Response Treatment Package (PRT-P)

Delayed Treatment Group

NO INTERVENTION

Delayed Treatment Group (DTG)

Interventions

Pivotal Response Treatment Package (PRT-P) BEHAVIORAL

Pivotal Response Treatment Package

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305-5719, United States

Location

Related Publications (2)

• 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):e20190178. doi: 10.1542/peds.2019-0178. Epub 2019 Aug 6.

  PMID: 31387868 RESULT

• Gengoux GW, Schapp S, Burton S, Ardel CM, Libove RA, Baldi G, Berquist KL, Phillips JM, Hardan AY. Effects of a parent-implemented Developmental Reciprocity Treatment Program for children with autism spectrum disorder. Autism. 2019 Apr;23(3):713-725. doi: 10.1177/1362361318775538. Epub 2018 May 18.

  PMID: 29775078 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Hardan, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: December 4, 2013
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)