Pivotal Response Treatment for Children With Autism Spectrum Disorders

Not Applicable

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Behavioral: Pivotal Response Training

• Registration Number: NCT01908686
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-26
• Primary Completion: 2019-12-01
• Study Completion: 2020-03-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Inclusion Criteria:

Participants will:

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

Read More

Exclusion Criteria

• Exclusion Criteria:

Participants may not have:

1. Any metal or electromagnetic implants, including:

   1. Cardiac pacemaker
   2. Defibrillator
   3. Artificial heart valve
   4. Aneurysm clip
   5. Cochlear implants
   6. Shrapnel
   7. Neurostimulators
   8. History of metal fragments in eyes or skin

2. Significant hearing loss or other severe sensory impairment

3. A fragile health status.

4. Current use of prescription medications that may affect cognitive processes under study.

5. A history of significant head trauma or serious brain or psychiatric illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS) Total Score	16 weeks

Secondary Outcome Measures

Name	Time	Method
Autism Diagnostic Observation Schedule (ADOS) Comparison Score	16 weeks
Aberrant Behavior Checklist (ABC)	16 weeks
Vineland Domain Scores	16 weeks
Clinical Global Impressions Scale (CGI-I)	16 weeks
Change in Eye Tracking (ET) patterns	16 weeks
Change in neural response to social stimuli using fMRI	16 weeks

Trial Locations

Locations (1)

Yale Child Study Center - Autism Program; 🇺🇸 New Haven, Connecticut, United States