Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA)

This study has been completed.
Sponsor:
Collaborators:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Vanderbilt University
University of California, Los Angeles
Information provided by (Responsible Party):
Connie Kasari, Ph.D., Autism Speaks
ClinicalTrials.gov Identifier:
NCT01013545
First received: November 12, 2009
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Joint Engagement + Enhanced Milieu Training
Joint Engagement + Enhanced Milieu Training+Augmentative Communication (AAC)
Behavioral: JAE Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developmental and Augmented Intervention for Facilitating Expressive Language

Resource links provided by NLM:


Further study details as provided by Autism Speaks:

Primary Outcome Measures:
  • Number of words used spontaneously during language sample [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in spontaneous language from beginning of treatment, to the mid-point.


Secondary Outcome Measures:
  • Number of words used spontaneously during language sample [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in spontaneous language used at the end of treatment.


Estimated Enrollment: 96
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013545

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Autism Speaks
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Vanderbilt University
University of California, Los Angeles
Investigators
Principal Investigator: Connie Kasari, Ph.D. University of California, Los Angeles
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Kasari, Ph.D., Principal Investigator, Professor, Ph.D., Autism Speaks
ClinicalTrials.gov Identifier: NCT01013545     History of Changes
Other Study ID Numbers: G09-04-013-01, 5666
Study First Received: November 12, 2009
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Autism Speaks:
joint engagement
augmentative communication (AAC)
enhanced milieu training
autism spectrum disorder
language

ClinicalTrials.gov processed this record on August 27, 2014