Research in Autism: Parent Intervention

Autistic Disorder Clinical Trial

Official title:

Research in Autism: Parent Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258465
• Other study ID #: MH39434
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: December 10, 2010
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this research project was to systematically compare two widely used types of intervention programs for children with autism within a parent training model. In one condition, randomly assigned children were provided with an intervention that typically results in acquisition of expressive words in a large percentage of children diagnosed as having autism, using a well-documented manualized intervention focused on verbal expressive communication only (Pivotal Response Training, PRT). In the other condi¬tion, randomly assigned children received a widely used intervention on the same social communication functions using a well-documented manualized augmentative system of intervention (Picture Exchange Communica¬tion System, PECS) that has been reported to produce verbal and nonverbal communication in large percentages of children diagnosed with autism. Children in the two conditions were compared for development of verbal and nonverbal communication, changes in disruptive behavior, changes in symptoms of autism, and general adaptive behavior gains. In addition, parent satisfaction and stress measures were gathered in order to assess the effects of each intervention on family functioning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 47 Months

Eligibility

Inclusion Criteria:

• Diagnosis of Autistic Disorder or At Risk of Autistic Disorder

• Age 2-0 to 3-11 years of age

• Use of fewer than 10 functional words at intake

Exclusion Criteria:

• Primary diagnosis of mental retardation

• Neurologic pathology (e.g., PKU, encephalitis, brain trauma)

• Major sensory impairment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Behavioral:
• Pivotal Response Training
Naturalistic behavioral protocol designed to teach vocal communication.
• Picture Exchange Communication System
Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.

Locations

Country	Name	City	State
United States	University of California, San Diego Psychology Department	La Jolla	California
United States	University of California, Santa Barbara, School of Education, Department of Clinical, Counseling, and School Psychology	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mullen Scales of Early Learning		23 weeks with three months follow-up	No
Secondary	Vineland Adaptive Behavior Scales		23 weeks and 3 month follow up	No