Skip to main content
Clinical Trials/NCT01250938
NCT01250938CompletedNot Applicable

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

University of California, Los Angeles2 sites in 1 country44 target enrollmentStarted: July 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
2
Primary Endpoint
Caregiver Transactional Support

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
24 Months to 54 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: ESI - Community Outreach (Behavioral)

Outcomes

Primary Outcomes

Caregiver Transactional Support

Time Frame: Weekly

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

Secondary Outcomes

  • Caregiver Outcome(All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly)
  • Child Outcome(All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Catherine Lord, Ph.D.

Principal Investigator

University of California, Los Angeles

Study Sites (2)

Loading locations...

Similar Trials