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

• ClinicalTrials.gov Identifier: NCT01751698
• Recruitment Status: Completed
• First Posted: December 18, 2012
• Last Update Posted: October 11, 2018
• Sponsor: University of California, Los Angeles
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism	Behavioral: JASP-EMT; Behavioral: DTT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 192 participants
• 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
• Actual Study Start Date: January 2013
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• 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

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:

Kasari C, Paparella T, Freeman S, Jahromi LB. Language outcome in autism: randomized comparison of joint attention and play interventions. J Consult Clin Psychol. 2008 Feb;76(1):125-37. doi: 10.1037/0022-006X.76.1.125.

Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. Erratum in: J Child Psychol Psychiatry. 2007 May;48(5):523.

Kaiser AP, Roberts MY. Parent-implemented enhanced milieu teaching with preschool children who have intellectual disabilities. J Speech Lang Hear Res. 2013 Feb;56(1):295-309. doi: 10.1044/1092-4388(2012/11-0231). Epub 2012 Jun 28.

Roberts MY, Kaiser AP. Assessing the effects of a parent-implemented language intervention for children with language impairments using empirical benchmarks: a pilot study. J Speech Lang Hear Res. 2012 Dec;55(6):1655-70. doi: 10.1044/1092-4388(2012/11-0236). Epub 2012 Apr 5.

Smith T, Scahill L, Dawson G, Guthrie D, Lord C, Odom S, Rogers S, Wagner A. Designing research studies on psychosocial interventions in autism. J Autism Dev Disord. 2007 Feb;37(2):354-66. Review.

Lord C, Wagner A, Rogers S, Szatmari P, Aman M, Charman T, Dawson G, Durand VM, Grossman L, Guthrie D, Harris S, Kasari C, Marcus L, Murphy S, Odom S, Pickles A, Scahill L, Shaw E, Siegel B, Sigman M, Stone W, Smith T, Yoder P. Challenges in evaluating psychosocial interventions for Autistic Spectrum Disorders. J Autism Dev Disord. 2005 Dec;35(6):695-708; discussion 709-11.

Pickett E, Pullara O, O'Grady J, Gordon B. Speech acquisition in older nonverbal individuals with autism: a review of features, methods, and prognosis. Cogn Behav Neurol. 2009 Mar;22(1):1-21. doi: 10.1097/WNN.0b013e318190d185. Review.

• 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 ); R01HD073975 ( U.S. NIH Grant/Contract )
• First Posted: December 18, 2012
• Last Update Posted: October 11, 2018
• Last Verified: October 2018

Keywords provided by Connie Kasari, Ph.D., University of California, Los Angeles:

Autism; Minimally Verbal; School Age