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Effectiveness of Early Intervention in an Underserved Population

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01250938
Acronym
ESI-CO
Enrollment
44
Registered
2010-12-01
Start date
2009-07-31
Completion date
2019-05-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

Keywords

autism, autism spectrum disorders, pervasive developmental disorders, intervention, low-income, underserved populations, underrepresented populations

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.

Interventions

BEHAVIORALESI - 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Autism Speaks
CollaboratorOTHER
Florida State University
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Months to 54 Months
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.

Exclusion criteria

-Must meet eligibility requirements stated above.

Design outcomes

Primary

MeasureTime frameDescription
Caregiver Transactional SupportWeeklyMeasures caregiver's development of behavioral strategies to support child's social and communicative behavior.

Secondary

MeasureTime frameDescription
Child OutcomeAll measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthlyChild measures of autism symptoms, social communication, developmental level, and adaptive behavior.
Caregiver OutcomeAll measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthlyCaregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026