Clinical trial NCT00953095: Social and Communication Outcomes for Young Children With Autism
Official title: Optimizing Social and Communication Outcomes for Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
treatment
joint attention
communication
language
Lead sponsor: Health Resources and Services Administration (HRSA)
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
name: University of Washington
name: University of Michigan
name: Florida State University
name: Johns Hopkins University
First posted: 2009-08-06
Enrollment: 112
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: Early Social Communication Scale
timeFrame: Before treatment, after treatment and 3 months after treatment
Secondary outcomes:
measure: Mullen Scales of Early Learning
timeFrame: Before treatment, after treatment, and 3 months after treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angles
state: California
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. doi: 10.1007/BF01537863. No abstract available.
citation: 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.
citation: Koegel RL, Bimbela A, Schreibman L. Collateral effects of parent training on family interactions. J Autism Dev Disord. 1996 Jun;26(3):347-59. doi: 10.1007/BF02172479.
citation: Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.
citation: Whalen C, Schreibman L. Joint attention training for children with autism using behavior modification procedures. J Child Psychol Psychiatry. 2003 Mar;44(3):456-68. doi: 10.1111/1469-7610.00135.
citation: Adamson LB, Bakeman R, Deckner DF, Romski M. Joint engagement and the emergence of language in children with autism and Down syndrome. J Autism Dev Disord. 2009 Jan;39(1):84-96. doi: 10.1007/s10803-008-0601-7. Epub 2008 Jun 26.
citation: Tomasello M, Farrar MJ. Joint attention and early language. Child Dev. 1986 Dec;57(6):1454-63.