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Social and Communication Outcomes for Young Children With Autism

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
University of Washington
University of Michigan
Florida State University
Johns Hopkins University
Information provided by (Responsible Party):
Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
ClinicalTrials.gov Identifier:
NCT00953095
First received: August 4, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

The goal of this project is to test an intervention program for caregivers and their young children with autism that is focused on improving social communication. This study specifically targets underserved populations, specifically children from low SES and racial/ethnic minority families. Participants will include 40 children (aged 24 months to 60 months) and their caregivers who will be randomized (as if by flipping a coin) to one of the two treatments: Parent education sessions for two hours a week for 12 weeks or parent-child intervention sessions with the child for one hour, twice a week for 12 weeks. Young children with autism have difficulty with engaging in joint attention with others (e.g. pointing, showing. Joint attention skills are important to later development of language. Therefore, targeting this problem in young children may result in better language outcomes for these children.

In order to examine the effects of the interventions, all participants will be complete cognitive, language, communication and play-based assessments prior to treatment, at the end of the first 12 weeks of the intervention, and post-treatment immediately following the intervention (approximately 2.5 to 3 hours each).


Condition Intervention
Autism Spectrum Disorder
 Behavioral: Joint Attention Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Optimizing Social and Communication Outcomes for Young Children With Autism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Resources and Services Administration (HRSA):

Primary Outcome Measures:
  • Early Social Communication Scale [ Time Frame: Before treatment, after treatment and 3 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mullen Scales of Early Learning [ Time Frame: Before treatment, after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caregiver Mediated Model (CMM)
focuses on joint attention/engagement intervention using an established evidence based treatment (Kasari et al., 2006). It involves meeting the parent and child in their home for one hour, twice a week for 12 weeks. In this intervention, the parent-child pair meet with the interventionist (as opposed to the group training in the CEM condition). Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input and coaching from the interventionist) as they implement these techniques with their child.
 Behavioral: Joint Attention Intervention
Intervention in both conditions occurs once a week for 2 hours. Participants will be randomized to 1 of 2 interventions : (1) Caregiver Mediated Model (CMM):focuses on joint attention/engagement and involves individual meetings with the parents and children at their homes. Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input/ coaching from the interventionist) as they implement these techniques with their child. (2) Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services. Parents will receive information on child development each week, and will be able to ask questions and discuss the information. Parents meet in a group (without their children) in a community-based setting to receive the intervention.
Experimental: Caregiver Education Model (CEM)
focuses on teaching parents information about autism, behavior modification, and community services using a manualized approach (Brereton & Tonge, 2005). Parents will receive information on child development each week, and will be able to ask questions and discuss the information vis-à-vis their own child. This intervention is manualized (Brereton & Tonge 2005). In the CEM condition, parents meet in a group (without their children) in a community-based setting to receive the intervention. Intervention sessions occur once a week for 2 hours.
 Behavioral: Joint Attention Intervention
Intervention in both conditions occurs once a week for 2 hours. Participants will be randomized to 1 of 2 interventions : (1) Caregiver Mediated Model (CMM):focuses on joint attention/engagement and involves individual meetings with the parents and children at their homes. Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input/ coaching from the interventionist) as they implement these techniques with their child. (2) Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services. Parents will receive information on child development each week, and will be able to ask questions and discuss the information. Parents meet in a group (without their children) in a community-based setting to receive the intervention.

Detailed Description:

Child/parent dyads will be randomized to one of two intervention conditions: (1) Parent-child model, also known as the Caregiver Education Model (CMM):focuses on joint attention/engagement intervention using an established evidence based treatment (Kasari et al., 2006). It involves individual interventionist meetings with the parents and their children in their homes for one hour, twice a week for 12 weeks. In this intervention, the parent-child pair meet with the interventionist (as opposed to the group training in the CEM condition). Parents will be specifically taught techniques for altering the home environment and ways to enhance children's language, social, and play development. Parents will given guided practice (input and coaching from the interventionist) as they implement these techniques with their child. (2)Parent-education intervention, also known as the Caregiver Education Model (CEM): focuses on teaching parents information about autism, behavior modification, and community services using a manualized approach (Brereton & Tonge, 2005). Parents will receive information on child development each week, and will be able to ask questions and discuss the information vis-à-vis their own child. This intervention is manualized (Brereton & Tonge 2005). In the CEM condition, parents meet in a group, without their children, in a community-based setting to receive the intervention. Intervention in both conditions occurs for 2 hours for 12 weeks.

  Eligibility

Ages Eligible for Study:   24 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953095

Locations
United States, California
University of California, Los Angles
Los Angeles, California, United States, 90095
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Health Resources and Services Administration (HRSA)
University of California, Los Angeles
University of Washington
University of Michigan
Florida State University
Johns Hopkins University
Investigators
Principal Investigator: Connie Kasari, Ph.D. University of California, Los Angeles
  More Information

Publications:
Mahoney, G., Kaiser, A., Girolametto, L., MacDonald, J., Robinson, C., Safford, P., & Spiker, D. (1999). Parent education in early intervention: A call for a renewed focus. Topics in Early Childhood Special Education, 19(3), 131-140.

Responsible Party: Connie Kasari, Ph.D., Professor of Psychological Studies in Education and Psychiatry, Health Resources and Services Administration (HRSA)
ClinicalTrials.gov Identifier: NCT00953095     History of Changes
Other Study ID Numbers: G09-02-016-01, UA3MC11055
Study First Received: August 4, 2009
Last Updated: June 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Health Resources and Services Administration (HRSA):
Autism Spectrum Disorder
treatment
joint attention
communication
language

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013