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

This study is not yet open for participant recruitment.
Verified October 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01751698
First received: December 14, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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, UCLA, University of Rochester, Vanderbilt University and Weill Cornell Medical Center with methodological and statistical support from University of Michigan.


Condition Intervention
Autism
 Behavioral: JASP-EMT
Behavioral: DTT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptive Interventions for Minimally Verbal Children With ASD in the Community

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Primary Outcome 1: Language Sample [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in socially communicative spontaneous utterances (SCU; primary outcome).


Secondary Outcome Measures:
  • Secondary Aim 1: Joint Engagement [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in object play level.


Other Outcome Measures:
  • Parent Training [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To compare and contrast four pre-specified adaptive interventions in terms of primary and secondary outcomes.

  • Moderators [ Time Frame: Follow-Up ] [ Designated as safety issue: No ]
    To determine whether (a) baseline repetitive behavior, (b) baseline object interest, and (c) parent expectations for the specific intervention moderate intervention outcomes.


Estimated Enrollment: 192
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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).
 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.

  Eligibility

Ages Eligible for Study:   54 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of autism
  • At least 4.5 years old, and not older than 8.0 years
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751698

Contacts
Contact: Connie Kasari, PhD (310) 825-8342 kasari@gseis.ucla.edu
Contact: Kelly Goods, PhD (310) 206-6104 kgoods@mednet.ucla.edu

Locations
United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Connie Kasari, PhD     310-825-8342     kasari@gseis.ucla.edu    
Contact: Kelly Goods, PhD     (310) 206-6104     kgoods@mednet.ucla.edu    
Principal Investigator: Connie Kasari, PhD            
United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Tristram Smith, PhD         Tristram_Smith@URMC.Rochester.edu    
Principal Investigator: Tristram Smith, PhD            
Weill Cornell Medical College Not yet recruiting
White Plains, New York, United States, 10605
Contact: Catherine Lord, PhD         cal2028@med.cornell.edu    
Principal Investigator: Catherine Lord, PhD            
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Ann Kaiser, PhD         ann.kasier@vanderbilt.edu    
Principal Investigator: Ann Kaiser, PhD            
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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
  More Information

Publications:

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01751698     History of Changes
Other Study ID Numbers: RO1HD073975, R01HD073975
Study First Received: December 14, 2012
Last Updated: December 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Autism
Minimally Verbal
School Age

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013