PRT for Adolescents With High Functioning Autism

Stanford University

Status: Enrolling

Conditions: Behavior, Child; Behavior, Social; Child Development; Autism Spectrum Disorder High-Functioning; Developmental Disability; Autism

Treatments: Behavioral: PRT for Adolescents

Study type: Interventional

Funder types: Other

Identifiers

NCT05987761

60502

Details and patient eligibility

About

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

Enrollment: 76 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs
• Intelligence Quotient (IQ): Participants with a Full Scale IQ > 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
• Right-handed
• No metal in their body/unremovable metal on their body (i.e., braces)
• First language is English
• Must live in the San Francisco Bay Area
• Able and willing to receive intervention weekly for 9 weeks
• Adolescent is interested in improving their social skills
• MRI Compatibility: No major contraindication for MRI.
• Diagnosis of ASD using ADOS-2 and ADI-R.
• No evidence of a genetic, metabolic, or infectious etiology for their autism.
• Primary diagnosis of ASD
• No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
• Stable treatment (e.g., ABA), 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.
• Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)
• No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.

Exclusion criteria

• History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age < 34 weeks
• Left-handed
• Braces or any metal in their body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

PRT Treatment Group

Experimental group

Description:

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. Participants in the PRT Treatment Group will complete an 9-week intervention, PRT for Adolescents, to improve the adolescent's social skills. Following the completion of the 9-week intervention, participants will be asked to complete a second MRI brain imaging session, followed by post-measure appointments in order to assess immediate effects of the intervention.

Treatment:

Behavioral: PRT for Adolescents

Delayed Treatment Group

Experimental group

Description:

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. After 9-weeks without any intervention, participants in the Delayed Treatment Group will be asked to complete a second MRI brain imaging session, followed by post-measure appointments, and will then receive the PRT intervention at the end of the study.

Treatment:

Behavioral: PRT for Adolescents