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

• ClinicalTrials.gov Identifier: NCT01250938
• Recruitment Status: Active, not recruiting
• First Posted: December 1, 2010
• Last Update Posted: July 23, 2018
• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH); Autism Speaks; Florida State University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Tracking Information

• First Submitted Date: November 30, 2010
• First Posted Date: December 1, 2010
• Last Update Posted Date: July 23, 2018
• Study Start Date: July 2009
• Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2010)

Caregiver Transactional Support [ Time Frame: Weekly ]

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01250938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 30, 2010)

• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Early Intervention in an Underserved Population
• Official Title: 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Autism Spectrum Disorders

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.

Other Name: Modified ESI

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 30, 2010): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2019
• Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 24 Months to 54 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01250938
• Other Study ID Numbers: 1108011843; Autism Speaks 5766 ( Other Grant/Funding Number: Autism Speaks ); R01MH078165 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

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.

• Responsible Party: Weill Medical College of Cornell University
• Study Sponsor: Weill Medical College of Cornell University

Collaborators

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

Investigators

• Principal Investigator: Catherine Lord, Ph.D.; Weill Medical College of Cornell University
• Principal Investigator: Amy Wetherby, Ph.D.; Florida State University

• PRS Account: Weill Medical College of Cornell University
• Verification Date: July 2018