Clinical trial NCT01751698: Adaptive Interventions for Minimally Verbal Children With ASD in the Community
Official title: Adaptive Interventions for Minimally Verbal Children With ASD in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Autism
Minimally Verbal
School Age
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-12-18
Enrollment: 192
Sex: ALL
Minimum age (years): 54
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Primary Outcome 1: Language Sample
timeFrame: Follow-Up; 8 months on average
Secondary outcomes:
measure: Secondary Aim 1: Joint Engagement
timeFrame: Follow-Up; 8 months on average
measure: Secondary Outcome 2: Number of Unique Words (Vocabulary)
timeFrame: Follow-Up; 8 months on average
measure: Secondary Outcome 3: Object Play
timeFrame: Follow-Up; 8 months on average
Other outcomes:
measure: Parent Training
timeFrame: Follow-Up; 8 months on average
measure: Treatment Effects
timeFrame: Follow-Up; 8 months on average
measure: Moderators
timeFrame: Follow-Up; 8 months on average
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: White Plains
country: United States
facility: Weill Cornell Medical College
state: New York
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Ann Kaiser, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Tristram Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Catherine Lord, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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