Effectiveness of Early Intervention in an Underserved Population (ESI-CO)
Primary Purpose
Autism Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESI - Community Outreach
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring autism, autism spectrum disorders, pervasive developmental disorders, intervention, low-income, underserved populations, underrepresented populations
Eligibility 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.
Sites / Locations
- Florida State University
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ESI - Community Outreach
Arm Description
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.
Outcomes
Primary Outcome Measures
Caregiver Transactional Support
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
Secondary Outcome Measures
Child Outcome
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.
Caregiver Outcome
Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
Full Information
NCT ID
NCT01250938
First Posted
November 30, 2010
Last Updated
May 8, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), Autism Speaks, Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT01250938
Brief Title
Effectiveness of Early Intervention in an Underserved Population
Acronym
ESI-CO
Official Title
2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), Autism Speaks, Florida State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
autism, autism spectrum disorders, pervasive developmental disorders, intervention, low-income, underserved populations, underrepresented populations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESI - Community Outreach
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ESI - Community Outreach
Other Intervention Name(s)
Modified ESI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver Transactional Support
Description
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Child Outcome
Description
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.
Time Frame
All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Title
Caregiver Outcome
Description
Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
Time Frame
All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Lord, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Wetherby, Ph.D.
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32301
Country
United States
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effectiveness of Early Intervention in an Underserved Population
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