Clinical trial NCT01250938: Effectiveness of Early Intervention in an Underserved Population
Official title: 2/2-Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: autism
autism spectrum disorders
pervasive developmental disorders
intervention
low-income
underserved populations
underrepresented populations
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Autism Speaks
name: Florida State University
First posted: 2010-12-01
Enrollment: 44
Sex: ALL
Minimum age (years): 24
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Caregiver Transactional Support
timeFrame: Weekly
Secondary outcomes:
measure: Child Outcome
timeFrame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
measure: Caregiver Outcome
timeFrame: All measures pre-treatment, post-treatment, and at 3 month follow-up. Some measures weekly and monthly
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: White Plains
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Catherine Lord, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Amy Wetherby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: