Adaptive Interventions for Minimally Verbal Children With ASD in the Community (AIM-ASD)
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 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|
- Primary Outcome 1: Language Sample [ Time Frame: Follow-Up; 8 months on average ] [ 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 Aim 1: Joint Engagement [ Time Frame: Follow-Up; 8 months on average ] [ 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; 8 months on average ] [ 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; 8 months on average ] [ 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.
- Parent Training [ Time Frame: Follow-Up; 8 months on average ] [ 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; 8 months on average ] [ 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; 8 months on average ] [ 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.
|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)|
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751698
|Contact: Connie Kasari, PhD||(310) firstname.lastname@example.org|
|Contact: Stephanie Y Shire, PhD||(310) email@example.com|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Connie Kasari, PhD 310-825-8342 firstname.lastname@example.org|
|Contact: Stephanie Y Shire, PhD (310) 825-6189 email@example.com|
|Principal Investigator: Connie Kasari, PhD|
|United States, New York|
|University of Rochester||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||Recruiting|
|White Plains, New York, United States, 10605|
|Contact: Catherine Lord, PhD firstname.lastname@example.org|
|Principal Investigator: Catherine Lord, PhD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Ann Kaiser, PhD email@example.com|
|Principal Investigator: Ann Kaiser, PhD|
|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|