Evaluating Parent Delivered Interventions for Children With Autism

Stanford University

Status: Completed

Conditions: Autistic Disorder; Developmental Disabilities

Treatments: Behavioral: Pivotal Response Training (PRT); Behavioral: PACE and PRT Hybrid; Behavioral: PACE Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01882153

SU-11232011-8727

Details and patient eligibility

About

The investigators will assess the efficacy of parent delivered interventions in the treatment of social and communication deficits in children with autism. By collecting information about parent and child functioning before and after intervention, the investigators will be able to determine whether the intervention is effective in improving child social communication and reducing parent stress.

Enrollment: 104 patients

Sex: All

Ages: 18 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for autism participants:

• Children between the ages of 1.6 and 17.11 years of age
• Males and females
• Diagnosis of autism based on DSM-IV-TR criteria, an expert clinical evaluation, and ADOS or ADI-R if needed
• Receiving or will receive a parent delivered intervention to alleviate symptoms related to their diagnosis of autistic disorder
• Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Inclusion Criteria for developmentally delayed participants:

• Will have an age range between 1.6 and 17.11 years of age
• Males or females
• Diagnosis of a developmental delay or disorder based on DSM-IV-TR, ICD-10, and an expert clinical evaluation
• Have historical evidence of significant abnormal developmental milestones as determined by neurological history
• Receiving or will receive a parent delivered intervention
• Have a care provider that will reliably bring subjects to their chosen intervention and clinic visits, and is trustworthy to provide accurate accounts of services provided to the subject

Exclusion Criteria for autism participants:

• Is medically unstable (e.g., more than one seizure a month)
• Have a medical diagnosis that causes autism like symptomology (e.g., Fragile X, Down syndrome, Angelman's syndrome, tuberous sclerosis, Rett's disorder)

Exclusion Criteria for developmentally delayed subjects:

• Is medically unstable (e.g., more than one seizure a month)
• Has a diagnosis of ASD

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Developmentally Based Intervention

Experimental group

Treatment:

Behavioral: PACE Therapy

Behavioral: PACE and PRT Hybrid

Behaviorally Based Intervention

Experimental group

Treatment:

Behavioral: Pivotal Response Training (PRT)

Behavioral: PACE and PRT Hybrid