Pivotal Response Treatment for Children With Autism Spectrum Disorders (PRT)

Yale University

Status: Completed

Conditions: Autism Spectrum Disorders

Treatments: Behavioral: Pivotal Response Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01908686

2R01NS035193-18 (U.S. NIH Grant/Contract)

1106008625

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 4 to 35 years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Pivotal Response Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Pivotal Response Training

Waitlist Control

No Intervention group

Description:

Children in WL will be offered treatment following WL condition.