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Pivotal Response Treatment for Children With Autism Spectrum Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01908686
Acronym
PRT
Enrollment
40
Registered
2013-07-26
Start date
2012-05-31
Completion date
2020-03-01
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

Keywords

ASD

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.

Interventions

Behavioral intervention for autism

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 35 Years
Healthy volunteers
No

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Social Responsiveness Scale (SRS) Total Score16 weeks

Secondary

MeasureTime frame
Autism Diagnostic Observation Schedule (ADOS) Comparison Score16 weeks
Aberrant Behavior Checklist (ABC)16 weeks
Clinical Global Impressions Scale (CGI-I)16 weeks
Change in Eye Tracking (ET) patterns16 weeks
Change in neural response to social stimuli using fMRI16 weeks
Vineland Domain Scores16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026