Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA)

July 10, 2013 updated by: Connie Kasari, Ph.D., Autism Speaks
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Kennedy Krieger Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JAE-EMT
The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist. This intervention condition uses spoken language as the mode of communication. Individual, single word targets will be selected based on the child's level of language production and specific interests. The targets are systematically modeled in response to child actions and attention during play. A sequence of milieu teaching prompts will also be used to elicit targets from the child when use of the target language is functional for the child.
Behavioral: JAE Intervention
The overall goal in each session will be for the caregiver-child dyad to be in a state of supported or coordinated joint engagement. In this state the child is aware of the other's activity, and may actively coordinate their attention between an object/toy and the caregiver. The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist.
Experimental: JAE-AAC
The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist. The mode of communication introduced in this intervention condition is a developmentally chosen augmentative communication device. These devices are provided with a set of individually selected visual-graphic symbols and a relevant lexicon. The use of the device is taught within natural communicative exchanges within play routines and daily activities.
Behavioral: JAE Intervention
The overall goal in each session will be for the caregiver-child dyad to be in a state of supported or coordinated joint engagement. In this state the child is aware of the other's activity, and may actively coordinate their attention between an object/toy and the caregiver. The interventionist will coach the caregiver and child while they engage in play routines established through collaboration between caregiver and interventionist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of words used spontaneously during language sample
Time Frame: 3 months
Change in spontaneous language from beginning of treatment, to the mid-point.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of words used spontaneously during language sample
Time Frame: 6 months
Change in spontaneous language used at the end of treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autism Speaks

Collaborators

University of California, Los Angeles
Vanderbilt University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

  • Principal Investigator: Connie Kasari, Ph.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G09-04-013-01
  • 5666 (Other Grant/Funding Number: Autism Speaks)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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