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Emergence of Generative Language

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mand Training
Matrix
Stimulus Equivalence Training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Children

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
  • Speaks primarily in one word utterances
  • English as their primary language
  • Follows simple 1-step instructions
  • Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks

Exclusion Criteria:

  • Children with significant problem behavior that interferes with structured intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    One Baseline Session

    Two Baseline Sessions

    Three Baseline Sessions

    Arm Description

    Designated for participants #1 and #2. Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.

    Designated for participants #3 and #4. Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.

    Designated for participants #5 and #6. Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.

    Outcomes

    Primary Outcome Measures

    Change in Mean Length of Utterances (MLU) during manding
    The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe. The goal of intervention is to increase of MLU to an average of 3 words per mand.
    Acquisition of noun-verb and color-shape combinations during tacting
    The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.
    Emergence of intraverbal responses
    The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).

    Secondary Outcome Measures

    Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
    The Macarthur Bates-Communicative Development Inventory (CDI) is completed by a parent/caregiver and evaluates current word use . A higher score indicates the use of more words.
    Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
    A goal of the intervention is to observe an increase in spontaneous mands, an increase in spontaneous tacts, as well as an increase in intraverbal responses.

    Full Information

    First Posted
    September 17, 2015
    Last Updated
    December 2, 2016
    Sponsor
    Emory University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02555241
    Brief Title
    Emergence of Generative Language
    Official Title
    Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    ASD, Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    One Baseline Session
    Arm Type
    Experimental
    Arm Description
    Designated for participants #1 and #2. Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
    Arm Title
    Two Baseline Sessions
    Arm Type
    Experimental
    Arm Description
    Designated for participants #3 and #4. Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
    Arm Title
    Three Baseline Sessions
    Arm Type
    Experimental
    Arm Description
    Designated for participants #5 and #6. Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session. Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks. Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mand Training
    Intervention Description
    The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Matrix
    Intervention Description
    The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stimulus Equivalence Training
    Intervention Description
    The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
    Primary Outcome Measure Information:
    Title
    Change in Mean Length of Utterances (MLU) during manding
    Description
    The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe. The goal of intervention is to increase of MLU to an average of 3 words per mand.
    Time Frame
    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
    Title
    Acquisition of noun-verb and color-shape combinations during tacting
    Description
    The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.
    Time Frame
    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
    Title
    Emergence of intraverbal responses
    Description
    The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).
    Time Frame
    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
    Secondary Outcome Measure Information:
    Title
    Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
    Description
    The Macarthur Bates-Communicative Development Inventory (CDI) is completed by a parent/caregiver and evaluates current word use . A higher score indicates the use of more words.
    Time Frame
    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
    Title
    Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
    Description
    A goal of the intervention is to observe an increase in spontaneous mands, an increase in spontaneous tacts, as well as an increase in intraverbal responses.
    Time Frame
    Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD) Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ) Speaks primarily in one word utterances English as their primary language Follows simple 1-step instructions Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks Exclusion Criteria: Children with significant problem behavior that interferes with structured intervention
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alice Shillingsburg
    Organizational Affiliation
    Emory University Assistant Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Emergence of Generative Language

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