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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751698
First Posted: December 18, 2012
Last Update Posted: September 13, 2017
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.
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
  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, University of California Los Angeles, 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptive Interventions for Minimally Verbal Children With ASD in the Community

Further study details as provided by Connie Kasari, Ph.D., University of California, Los Angeles:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 192
Study Start Date: January 2013
Estimated Study Completion Date: October 2017
Primary Completion Date: June 2017 (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.

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   54 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751698


Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Weill Cornell Medical College
White Plains, New York, United States, 10605
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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: Connie Kasari, Ph.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01751698     History of Changes
Other Study ID Numbers: R01HD073975 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2012
First Posted: December 18, 2012
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Connie Kasari, Ph.D., University of California, Los Angeles:
Autism
Minimally Verbal
School Age