Effectiveness of Early Intervention in an Underserved Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Michigan.
Recruitment status was  Recruiting
Autism Speaks
Florida State University
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
First received: November 30, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 30, 2010
November 30, 2010
July 2009
May 2013   (final data collection date for primary outcome measure)
Caregiver Transactional Support [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
Same as current
No Changes Posted
  • Child Outcome [ Time Frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly ] [ Designated as safety issue: No ]
    Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.
  • Caregiver Outcome [ Time Frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly ] [ Designated as safety issue: No ]
    Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
Same as current
Not Provided
Not Provided
Effectiveness of Early Intervention in an Underserved Population
2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum

The purpose of this study is to test the applicability of a caregiver-implemented autism intervention protocol to a deliberately recruited low-income, underserved population.

Families of racial/ethnic minority, lower levels of education, and those who live in non-metropolitan areas have been found to experience greater limitations in accessing services for Autism Spectrum Disorder (ASD) (Thomas, Ellis, McLaurin, Daniels, & Morrissey, 2007). Black and Hispanic children have been found to have lower odds of having a documented ASD classification than white children (Mandell, Wiggins, Arnstein Carpenter, Daniels, Durkin et al., 2009) and of those children who do receive an ASD diagnosis, many of them are not diagnosed in early childhood. The age of first ASD diagnosis received has been found to be significantly higher for African American and Latino children compared to white children (Mandell, Listerud, Levy, & Pinto-Martin, 2002). For these reasons, it is important that the effectiveness of intensive early intervention for children with ASD is examined across varying cultural and socioeconomic backgrounds.

This project is directed by Dr. Catherine Lord at the University of Michigan, in collaboration with Dr. Amy Wetherby at Florida State University to test the applicability of a modified caregiver-implemented autism intervention (Modified Early Social Interaction; ESI) to a deliberately recruited low-income, underserved population. UM will recruit 28 children and FSU will recruit 16 children diagnosed with ASD who are between 24 and 42 months of age over a period of 3 years, totaling 44 caregiver-child dyads. This study will utilize a multiple baseline single-subject research design. Dyads will complete 1 month of weekly 1-hour baseline observations followed by three months of the modified ESI intervention. Child and family characteristics predicting response to intervention will be identified and findings will contribute to the development of autism interventions serving families from diverse backgrounds.

Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism Spectrum Disorders
Behavioral: Early Social Interaction - Community Outreach (ESI-CO)
This is an individualized caregiver-implemented intervention (ESI-CO) offered in 2 weekly sessions to teach caregivers how to embed strategies to support social communication skills within everyday routines, activities, and places for 3 months. Additionally, families receive 6 months (3 months during weekly home sessions and three months upon the completion of weekly home sessions) of resource support to identify local and community autism programs available for continued intervention and services.
Other Name: Modified ESI
Experimental: ESI-CO
All families receive the same ESI-CO treatment for 3 months in addition to 6 months of community resource support.
Intervention: Behavioral: Early Social Interaction - Community Outreach (ESI-CO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • caregiver(s) with less than a 4-year college degree
  • family income equal to or below 2x the federal poverty line
  • English as the predominantly-spoken language.
  • child received diagnosis of autism spectrum disorder before treatment
  • child is between 24 and 42 months at the start of treatment
  • child has normal hearing and adequate motor control to make simple actions (giving, reaching)
  • family agrees to 2-4 weeks of weekly 1-hour observations, 3 months of 2 intervention sessions per week, and 3 months of 1 intervention session per month.
  • family agrees to pre-treatment, post-treatment, and follow-up evaluation and videotaping of intervention sessions and weekly video check during the treatment.
24 Months to 54 Months
Contact: Themba Carr, M.S. 734-936-8601 tmhcarr@umich.edu
Contact: Kristina Lopez, M.A. 734-936-8781 klopez@umich.edu
United States
MH07816502S1, Autism Speaks 5766
Catherine Lord, Professor and PI, University of Michigan
University of Michigan
  • National Institute of Mental Health (NIMH)
  • Autism Speaks
  • Florida State University
Principal Investigator: Catherine Lord, Ph.D. University of Michigan
Principal Investigator: Amy Wetherby, Ph.D. Florida State University
University of Michigan
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP