NCT01250938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

9.8 years

First QC Date

November 30, 2010

Last Update Submit

May 8, 2023

Conditions

Autism Spectrum Disorders

Keywords

autismautism spectrum disorderspervasive developmental disordersinterventionlow-incomeunderserved populationsunderrepresented populations

Outcome Measures

Primary Outcomes (1)

  • Caregiver Transactional Support

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

    Weekly

Secondary Outcomes (2)

  • Child Outcome

    All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly

  • Caregiver Outcome

    All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly

Study Arms (1)

ESI - Community Outreach

EXPERIMENTAL

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.

Behavioral: ESI - Community Outreach

Interventions

ESI - Community OutreachBEHAVIORAL

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.

Also known as: Modified ESI
ESI - Community Outreach

Eligibility Criteria

Age24 Months - 54 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Must meet eligibility requirements stated above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University

Tallahassee, Florida, 32301, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Catherine Lord, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Amy Wetherby, Ph.D.

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 1, 2010

Study Start

July 1, 2009

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(2)