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

June 13, 2024 updated by: Connie Kasari, Ph.D., University of California, Los Angeles
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California, Los Angeles
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
      • White Plains, New York, United States, 10605
        • Weill Cornell Medical College
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Follow-Up; 8 months on average

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Follow-Up; 8 months on average
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.
Follow-Up; 8 months on average
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.
Follow-Up; 8 months on average

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Follow-Up; 8 months on average
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.
Follow-Up; 8 months on average
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.
Follow-Up; 8 months on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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
  • Principal Investigator: Connie Kasari, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HD073975 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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