Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Autism Speaks
Florida State University
Information provided by (Responsible Party):
Catherine Lord, Ph.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01250938
First received: November 30, 2010
Last updated: September 7, 2016
Last verified: September 2016

November 30, 2010
September 7, 2016
July 2009
May 2017   (final data collection date for primary outcome measure)
Caregiver Transactional Support [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Measures caregiver's development of behavioral strategies to support child's social and communicative behavior.
Same as current
Complete list of historical versions of study NCT01250938 on ClinicalTrials.gov Archive Site
  • Child Outcome [ Time Frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly ] [ Designated as safety issue: No ]
    Child measures of autism symptoms, social communication, developmental level, and adaptive behavior.
  • Caregiver Outcome [ Time Frame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly ] [ Designated as safety issue: No ]
    Caregiver measures self-reported family functioning, resources, well-being and treatment adherence, fidelity, and satisfaction
Same as current
Not Provided
Not Provided
 
Effectiveness of Early Intervention in an Underserved Population
2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autism Spectrum Disorders
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.
Other Name: Modified ESI
Experimental: ESI - Community Outreach
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.
Intervention: Behavioral: ESI - Community Outreach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
May 2017
May 2017   (final data collection date for primary outcome measure)

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.

Both
24 Months to 54 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250938
1108011843, Autism Speaks 5766, R01MH078165
Yes
Yes

Data are maintained by Florida Statue University, the data coordinating center for this collaborative project. We have shared deidentified study data by depositing it in the NIH National Database for Autism Research (NDAR).

We have a long-standing commitment to making our data available to other investigators. As part of our previous work with NIMH (e.g. NIMH Collaborative RO1 MH089390) and others (e.g. Simons Simplex Collection), our data collection methods and data structures have been designed with NDAR's data-sharing protocol in mind (we collect information necessary to generate the Global Unique Identifier). Our study uses standardized assessments and all data are maintained in a secure database.

Catherine Lord, Ph.D., Weill Medical College of Cornell University
Weill Medical College of Cornell University
  • National Institute of Mental Health (NIMH)
  • Autism Speaks
  • Florida State University
Principal Investigator: Catherine Lord, Ph.D. Weill Medical College of Cornell University
Principal Investigator: Amy Wetherby, Ph.D. Florida State University
Weill Medical College of Cornell University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP