Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adaptive Interventions for Minimally Verbal Children With ASD in the Community (AIM-ASD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01751698
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Connie Kasari, Ph.D., University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE December 14, 2012
First Posted Date  ICMJE December 18, 2012
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Primary Outcome 1: Language Sample [ Time Frame: Follow-Up; 8 months on average ]
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
Primary Outcome 1: Language Sample [ Time Frame: Follow-Up ]
To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Secondary Aim 1: Joint Engagement [ Time Frame: Follow-Up; 8 months on average ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in symbol-infused joint engagement.
  • Secondary Outcome 2: Number of Unique Words (Vocabulary) [ Time Frame: Follow-Up; 8 months on average ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in number of unique words.
  • Secondary Outcome 3: Object Play [ Time Frame: Follow-Up; 8 months on average ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in object play level.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2012)
  • Secondary Aim 1: Joint Engagement [ Time Frame: Follow-Up ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in symbol-infused joint engagement.
  • Secondary Outcome 2: Number of Unique Words (Vocabulary) [ Time Frame: Follow-Up ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in number of unique words.
  • Secondary Outcome 3: Object Play [ Time Frame: Follow-Up ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in object play level.
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2013)
  • Parent Training [ Time Frame: Follow-Up; 8 months on average ]
    To determine whether adding a parent training component provides additional benefit among participants who demonstrate a positive early response to either JASP-EMT or CORE-DTT.
  • Treatment Effects [ Time Frame: Follow-Up; 8 months on average ]
    To compare and contrast four pre-specified adaptive interventions in terms of primary and secondary outcomes.
  • Moderators [ Time Frame: Follow-Up; 8 months on average ]
    To determine whether (a) baseline repetitive behavior, (b) baseline object interest, and (c) parent expectations for the specific intervention moderate intervention outcomes.
Original Other Pre-specified Outcome Measures
 (submitted: December 14, 2012)
  • Parent Training [ Time Frame: Follow-Up ]
    To determine whether adding a parent training component provides additional benefit among participants who demonstrate a positive early response to either JASP-EMT or CORE-DTT.
  • Treatment Effects [ Time Frame: Follow-Up ]
    To compare and contrast four pre-specified adaptive interventions in terms of primary and secondary outcomes.
  • Moderators [ Time Frame: Follow-Up ]
    To determine whether (a) baseline repetitive behavior, (b) baseline object interest, and (c) parent expectations for the specific intervention moderate intervention outcomes.
 
Descriptive Information
Brief Title  ICMJE Adaptive Interventions for Minimally Verbal Children With ASD in the Community
Official Title  ICMJE Adaptive Interventions for Minimally Verbal Children With ASD in the Community
Brief Summary Adaptive Interventions for Minimally Verbal Children with ASD in the Community, seeks support to construct an adaptive intervention that utilizes two efficacious interventions (JASP-EMT and CORE- DTT) that have shown promise for optimizing the number of unique socially communicative and spontaneously spoken words in minimally verbal children with ASD. The study utilizes a novel sequential multiple assignment-randomized trial to evaluate and construct an optimal adaptive intervention. A total of 192 minimally verbal school aged children with an Autism Spectrum Disorder (aged 5 to 8 years of age) will participate across four sites, University of California Los Angeles, University of Rochester, Vanderbilt University and Weill Cornell Medical Center with methodological and statistical support from University of Michigan.
Detailed Description

Interventions:

  • CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field. The participants in the proposed study will have had at least 1 year of previous intervention, likely in an ABA program with DTT as a main strategy. While many children will have been exposed to DTT prior to entering this trial, it is important to insure that children (a) receive quality DTT, and (b) have exposure to CORE elements related to language learning, specifically joint attention and requesting gestures, in order to make the comparison with JASP-EMT.
  • JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers. For minimally verbal children with autism, meaningful social interaction is essential for establishing the platform on which language input and development will be built.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • Behavioral: JASP-EMT
    JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers.
  • Behavioral: DTT
    CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field.
Study Arms  ICMJE
  • Active Comparator: JASP-EMT
    JASP-EMT (Joint Attention, Symbolic Play and Enhanced Milieu Teaching) focuses on creating a context for joint engagement within naturally occurring child-led play routines. There is evidence of the effects of these interventions with children with ASD, and pilot data showing effects with minimally verbal children.
    Intervention: Behavioral: JASP-EMT
  • Active Comparator: DTT
    CORE-DTT (discrete trial training for core features of ASD) emphasizes didactic adult-led instruction and is considered the current evidenced-based 'standard of care' for children with autism (NRC, 2001).
    Intervention: Behavioral: DTT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 14, 2012)
192
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of autism
  • At least 4 years, 6 months old, and not older than 8 years, 0 months
  • Displays less than 20 spontaneous, unique, and socially communicative words during screening assessments
  • At least 18 months developmental age
  • Currently in school

Exclusion Criteria:

  • Diagnosis of syndrome or degenerative disorder
  • Poorly controlled seizures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 54 Months to 96 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01751698
Other Study ID Numbers  ICMJE R01HD073975( U.S. NIH Grant/Contract )
R01HD073975 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie Kasari, Ph.D., University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Connie Kasari, PhD University of California, Los Angeles
Principal Investigator: Ann Kaiser, PhD Vanderbilt University
Principal Investigator: Tristram Smith, PhD University of Rochester
Principal Investigator: Catherine Lord, PhD Weill Medical College of Cornell University
PRS Account University of California, Los Angeles
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP