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Completed

NCT Number: NCT01250938

Effectiveness of Early Intervention in an Underserved Population

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.

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Key information

Age range

24 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESI - Community Outreach

Behavioral

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 names: Modified ESI

Primary outcomes

  1. Caregiver Transactional Support

    Time frame: Weekly

    Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Autism Speaks
  • Florida State University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: ESI-CO

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2010
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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