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Completed

NCT Number: NCT01013545

Developmental and Augmented Intervention for Facilitating Expressive Language

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).

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

JAE Intervention

Behavioral

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.

Primary outcomes

  1. 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

  1. Number of words used spontaneously during language sample

    Time frame: 6 months

    Change in spontaneous language used at the end of treatment.

Sponsors and collaborators

Lead sponsor

Autism Speaks

Other

Collaborators

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

Registry information

Acronym: CCNIA

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 13, 2009
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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