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Clinical Trials/NCT01013545
NCT01013545
Completed
Not Applicable

Developmental and Augmented Intervention for Facilitating Expressive Language

Autism Speaks3 sites in 1 country96 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Engagement + Enhanced Milieu Training
Sponsor
Autism Speaks
Enrollment
96
Locations
3
Primary Endpoint
Number of words used spontaneously during language sample
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study will contrast two experimental treatment conditions by testing whether joint attention/joint engagement intervention using spoken communication (JAE-EMT) results in better outcomes than joint attention/joint engagement intervention that is instead supplemented with an individualized AAC system (JAE-AAC). Thus, the skills of joint attention/joint engagement (JAE) remain foundational to developing expressive language but the difference in the two treatments will be between whether the JAE is administered through the more traditional spoken means (EMT) or through an augmentative and alternative communication device (AAC).

Detailed Description

Both treatments will be manualized and a novel research design method called Sequential Multiple Assignment Randomized Trial (SMART) will be applied. SMART design will allow the interventionists to adjust the course of treatment based on whether the children respond to the treatment. More specifically, there will be two stages of intervention and during Stage 1, 90 nonverbal (e.g. those who have less than 5 spoken words) children with ASD between 5 and 8 years of age will be randomly assigned to either the JAE-EMT or JAE-AAC group. After receiving the assigned Stage 1 treatment for 12 weeks, all participants will be assessed to see if they responded to the Stage 1 treatment. If the children do respond to Stage 1 treatment, they will continue with that same treatment for another 12 weeks in Stage 2. A different treatment sequence will be used for those who do not respond to Stage 1 treatment where these non-responders will be re-assigned to 1 of 3 alternative intervention conditions. For example, those who do not respond to JAE-AAC will have the intensity of that same JAE-AAC treatment increased. Those who do not respond to the other, JAE-EMT treatment will be randomly assigned to either a more intense JAE-EMT condition, or the original JAE-AAC implemented in Stage 1. At the end of Stage 2, another follow-up assessment of cognitive, language, and social communication skills will be administered. Furthermore, several children who enter the study in the early stages will be tested again, 3 months after the Stage 2 follow up (not all children will be able to be tested at 9 months within the 3 year grant period).

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
December 2012
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Connie Kasari, Ph.D.

Principal Investigator, Professor, Ph.D.

Autism Speaks

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of autism from a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by Module 1 of the Autism Diagnostic Observation Schedule (Lord et al., 2001)
  • Chronological age between 5 and 8 years
  • Classified as nonverbal with fewer than 20 spontaneous expressive words as determined by parent report, language sample, and standardized tests.
  • Demonstrated slow or no progress in expressive language acquisition despite at least 2 years of early intervention

Exclusion Criteria

  • Major medical conditions other than autism, specifically: a) motor disabilities such as cerebral palsy or tuberous sclerosis, b) sensory disabilities such as blindness or deafness, and c) genetic disorders such as Fragile X or Down syndrome.
  • Nonverbal mental age \< 24 months, based on a nonverbal score from the Leiter-R (Roid \& Miller, 1997).

Outcomes

Primary Outcomes

Number of words used spontaneously during language sample

Time Frame: 3 months

Change in spontaneous language from beginning of treatment, to the mid-point.

Secondary Outcomes

  • Number of words used spontaneously during language sample(6 months)

Study Sites (3)

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