Effectiveness of Early Intervention in an Underserved Population (ESI-CO)
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|ClinicalTrials.gov Identifier: NCT01250938|
Recruitment Status : Active, not recruiting
First Posted : December 1, 2010
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Behavioral: ESI - Community Outreach||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
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
- Caregiver Transactional Support [ Time Frame: Weekly ]Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
- Child Outcome [ Time Frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly ]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 ]Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250938
|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|
|Principal Investigator:||Catherine Lord, Ph.D.||Weill Medical College of Cornell University|
|Principal Investigator:||Amy Wetherby, Ph.D.||Florida State University|