Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effectiveness of Early Intervention in an Underserved Population (ESI-CO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Autism Speaks
Florida State University
Information provided by (Responsible Party):
Catherine Lord, Ph.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01250938
First received: November 30, 2010
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Autism Spectrum Disorders
Behavioral: ESI - Community Outreach

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: July 2009
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESI - Community Outreach
All families receive the same Early Social Intervention - Community Outreach (ESI-CO) treatment for 3 months in addition to 6 months of community resource support.
Behavioral: ESI - Community Outreach
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   24 Months to 54 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

-Must meet eligibility requirements stated above.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250938

Locations
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32301
United States, New York
Weill Cornell Medical College
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Autism Speaks
Florida State University
Investigators
Principal Investigator: Catherine Lord, Ph.D. Weill Medical College of Cornell University
Principal Investigator: Amy Wetherby, Ph.D. Florida State University
  More Information

Responsible Party: Catherine Lord, Ph.D., Principal Investigator, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01250938     History of Changes
Other Study ID Numbers: 1108011843  Autism Speaks 5766  R01MH078165 
Study First Received: November 30, 2010
Last Updated: September 7, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

Data are maintained by Florida Statue University, the data coordinating center for this collaborative project. We have shared deidentified study data by depositing it in the NIH National Database for Autism Research (NDAR).

We have a long-standing commitment to making our data available to other investigators. As part of our previous work with NIMH (e.g. NIMH Collaborative RO1 MH089390) and others (e.g. Simons Simplex Collection), our data collection methods and data structures have been designed with NDAR's data-sharing protocol in mind (we collect information necessary to generate the Global Unique Identifier). Our study uses standardized assessments and all data are maintained in a secure database.


Keywords provided by Weill Medical College of Cornell University:
autism
autism spectrum disorders
pervasive developmental disorders
intervention
low-income
underserved populations
underrepresented populations

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016