Effectiveness of Early Intervention in an Underserved Population

Autism Spectrum Disorders Clinical Trial

— ESI-CO  

Official title:

2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250938
• Other study ID #: 1108011843
• Secondary ID: Autism Speaks 57
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: May 2019

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 54 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	Autism Speaks, Florida State University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Transactional Support	Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.	Weekly
Secondary	Child Outcome	Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.	All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Secondary	Caregiver Outcome	Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction	All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly