Pivotal Response Treatment for Children With Autism Spectrum Disorders

NCT01908686 | Completed DMC

• 2 other identifiers: 11060086252R01NS035193-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Conditions

Autism Spectrum Disorders

Keywords

ASD

Outcome Measures

Primary Outcomes (1)

• Social Responsiveness Scale (SRS) Total Score

  16 weeks

Secondary Outcomes (6)

• Clinical Global Impressions Scale (CGI-I)

  16 weeks

• Autism Diagnostic Observation Schedule (ADOS) Comparison Score

  16 weeks

• Aberrant Behavior Checklist (ABC)

  16 weeks

• Vineland Domain Scores

  16 weeks

• Change in Eye Tracking (ET) patterns

  16 weeks

Study Arms (2)

Pivotal Response Training

ACTIVE COMPARATOR

Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis

Behavioral: Pivotal Response Training

Waitlist Control

NO INTERVENTION

Children in WL will be offered treatment following WL condition.

Interventions

Pivotal Response Training BEHAVIORAL

Behavioral intervention for autism

Also known as: Pivotal Response Treatment

Pivotal Response Training

Eligibility Criteria

• Age: 4 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants will:
• Fit the age requirement: age 4-35
• Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team.
• Be in good medical health
• Be cooperative with testing
• English is a language spoken in the family
• Successfully complete an fMRI and EEG scan
• Full-scale IQ\>50

You may not qualify if:

• Participants may not have:
• Any metal or electromagnetic implants, including:
• Cardiac pacemaker
• Defibrillator
• Artificial heart valve
• Aneurysm clip
• Cochlear implants
• Shrapnel
• Neurostimulators
• History of metal fragments in eyes or skin
• Significant hearing loss or other severe sensory impairment
• A fragile health status.
• Current use of prescription medications that may affect cognitive processes under study.
• A history of significant head trauma or serious brain or psychiatric illness

Sponsors & Collaborators

• Yale University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Yale Child Study Center - Autism Program

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 26, 2013
• Study Start: May 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

US (1)