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CompletedNCT00953095Updated Sep 25, 2014

Social and Communication Outcomes for Young Children With Autism

An interventional study of Joint Attention Intervention in Autism Spectrum Disorder, sponsored by Health Resources and Services Administration (HRSA). Completed at 5 sites in United States. Open to participants aged 24 Months to 60 Months. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by Health Resources and Services Administration (HRSA) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
24 Months to 60 Months
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Autism Spectrum Disorder
  • treatment
  • joint attention
  • communication
  • language
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's enrollment of 112 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Health Resources and Services Administration (HRSA) is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
24 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
112 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralJoint 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.

06

What researchers measure

Primary outcomes

  1. Early Social Communication Scale

    Time frame: Before treatment, after treatment and 3 months after treatment

Secondary outcomes

  1. Mullen Scales of Early Learning

    Time frame: Before treatment, after treatment, and 3 months after treatment

07

Study locations

5 sites
  • University of California, Los Angles
    Los Angeles, California 90095, United States
  • Florida State University
    Tallahassee, Florida 32306, United States
  • Kennedy Krieger Institute
    Baltimore, Maryland 21211, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • University of Washington
    Seattle, Washington 98195, United States
08

References and documents

Publications

  • 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. PubMed 670129 ↗
  • 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.
  • 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. PubMed 8792265 ↗
  • 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. Erratum In: J Child Psychol Psychiatry. 2007 May;48(5):523. PubMed 16712638 ↗
  • 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. PubMed 12635974 ↗
  • 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. PubMed 18581223 ↗
  • Tomasello M, Farrar MJ. Joint attention and early language. Child Dev. 1986 Dec;57(6):1454-63. PubMed 3802971 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00953095
Lead sponsor
Health Resources and Services Administration (HRSA)
Responsible party
Connie Kasari, Ph.D. (Professor of Psychological Studies in Education and Psychiatry, Health Resources and Services Administration (HRSA)) — Principal investigator
First posted
Aug 6, 2009
Start date
Apr 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Sep 25, 2014

Study contacts

Connie Kasari, Ph.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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