NCT00953095

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

August 4, 2009

Last Update Submit

September 22, 2014

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disordertreatmentjoint attentioncommunicationlanguage

Outcome Measures

Primary Outcomes (1)

  • Early Social Communication Scale

    Before treatment, after treatment and 3 months after treatment

Secondary Outcomes (1)

  • Mullen Scales of Early Learning

    Before treatment, after treatment, and 3 months after treatment

Study Arms (2)

Caregiver Mediated Model (CMM)

EXPERIMENTAL

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

Caregiver Education Model (CEM)

EXPERIMENTAL

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

Joint Attention InterventionBEHAVIORAL

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.

Caregiver Education Model (CEM)Caregiver Mediated Model (CMM)

Eligibility Criteria

Age24 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Los Angles

Los Angeles, California, 90095, United States

Location

Florida State University

Tallahassee, Florida, 32306, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (8)

  • 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.

    PMID: 670129BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 8792265BACKGROUND

  • 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.

    PMID: 16712638BACKGROUND

  • 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.

    PMID: 12635974BACKGROUND

  • 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.

    PMID: 18581223BACKGROUND

  • Tomasello M, Farrar MJ. Joint attention and early language. Child Dev. 1986 Dec;57(6):1454-63.

    PMID: 3802971BACKGROUND

  • Swain D, Li Y, Brown HR, Petkova E, Lord C, Rogers SJ, Estes A, Kasari C, Kim SH. Implementing a Uniform Outcome Measurement Approach for Early Interventions of Autism Spectrum Disorders. J Am Acad Child Adolesc Psychiatry. 2025 Jun;64(6):699-709. doi: 10.1016/j.jaac.2024.06.004. Epub 2024 Jul 2.

    PMID: 38964630DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderCommunicationLanguage

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Connie Kasari, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychological Studies in Education and Psychiatry

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(5)