Social and Communication Outcomes for Young Children With Autism

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00953095
• Date of registration: 04/08/2009
• Primary sponsor: Health Resources and Services Administration (HRSA)
• Public title: Social and Communication Outcomes for Young Children With Autism
• Scientific title: Optimizing Social and Communication Outcomes for Young Children With Autism
• Date of first enrolment: April 2009
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00953095
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Connie Kasari, Ph.D.
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children must be between 24 months and 60 months at entry into the study

- Children must have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on
the ADOS for ASD or autism

- Children must have an age equivalent of 12 months or greater for non-verbal ability
based on the Mullen Visual Reception and Fine Motor scales

- Caregiver and child must be available for all assessments

- Children must be able to walk independently

- Parents must be between the ages of 16 and 50 years old

- Family should be currently underserved (inability to obtain services for their child)
and have limited family resources

Exclusion Criteria:

- Children must not have a seizure disorder

- Children must not have associated sensory (uncorrected hearing loss greater than 20
db or vision loss) or physical disorders that restrict mobility (e.g., cerebral
palsy)

- Children must not have sustained a head injury

- Children's diagnosis of autism spectrum disorder must not be comorbid with other
medical syndromes (e.g., Tuberose Sclerosis, Neurofibromatosis, Down syndrome,
fragile X) or diseases

- Children must not be in foster care

- English must be the primary language spoken at home

- Parents must not have a psychiatric diagnosis or a diagnosis of mental retardation



Age minimum: 24 Months
Age maximum: 60 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorder

Intervention(s)

Behavioral: Joint Attention Intervention

Primary Outcome(s)

Early Social Communication Scale [Time Frame: Before treatment, after treatment and 3 months after treatment]

Secondary Outcome(s)

Mullen Scales of Early Learning [Time Frame: Before treatment, after treatment, and 3 months after treatment]

Secondary ID(s)

G09-02-016-01

UA3MC11055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Florida State University

Johns Hopkins University

University of California, Los Angeles

University of Michigan

University of Washington