Effectiveness of Early Intervention in an Underserved Population
Recruitment status was Recruiting
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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: Early Social Interaction - Community Outreach (ESI-CO) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
- 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.
- 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 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ESI-CO
All families receive the same ESI-CO treatment for 3 months in addition to 6 months of community resource support.
|
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
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Themba Carr, M.S. | 734-936-8601 | tmhcarr@umich.edu |
| Contact: Kristina Lopez, M.A. | 734-936-8781 | klopez@umich.edu |
| United States, Florida | |
| Florida State University | Recruiting |
| Tallahassee, Florida, United States, 32301 | |
| Contact: Renee Holland 850-922-9817 renee.holland@med.fsu.edu | |
| Principal Investigator: Amy Wetherby, Ph.D. | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Julie McCormick, M.A. 734-764-4048 mccormj@umich.edu | |
| Principal Investigator: Catherine Lord, Ph.D. | |
| Principal Investigator: | Catherine Lord, Ph.D. | University of Michigan |
| Principal Investigator: | Amy Wetherby, Ph.D. | Florida State University |
More Information
No publications provided
| Responsible Party: | Catherine Lord, Professor and PI, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01250938 History of Changes |
| Other Study ID Numbers: | MH07816502S1, Autism Speaks 5766 |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 30, 2010 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
autism autism spectrum disorders pervasive developmental disorders intervention |
low-income underserved populations underrepresented populations |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013