Skip to main content
OpenTrials
Completed

NCT Number: NCT01751698

Adaptive Interventions for Minimally Verbal Children With ASD in the Community

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

54 month–96 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JASP-EMT

Behavioral

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.

DTT

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: AIM-ASD

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2012
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.