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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Autism Spectrum Disorders

Treatments: Behavioral: ESI - Community Outreach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01250938

Autism Speaks 5766 (Other Grant/Funding Number)

1108011843

R01MH078165 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 24 to 54 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

ESI - Community Outreach

Experimental group

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.

Treatment:

Behavioral: ESI - Community Outreach