This trial is active, not recruiting.

Condition autism spectrum disorders
Treatment esi - community outreach
Sponsor Weill Medical College of Cornell University
Collaborator National Institute of Mental Health (NIMH)
Start date July 2009
End date May 2017
Trial size 44 participants
Trial identifier NCT01250938, 1108011843, Autism Speaks 5766, R01MH078165


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
esi - community outreach Modified ESI
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.

Primary Outcomes

Caregiver Transactional Support
time frame: Weekly

Secondary Outcomes

Child Outcome
time frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Caregiver Outcome
time frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly

Eligibility Criteria

Male or female participants from 24 months up to 54 months old.

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.

Additional Information

Official title 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
Principal investigator Catherine Lord, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.