Adaptive Interventions for Minimally Verbal Children With ASD in the Community

NCT01751698 | Completed

• 1 other identifier: R01HD073975
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 4

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.

Conditions

Autism

Keywords

Autism; Minimally Verbal; School Age

Outcome Measures

Primary Outcomes (1)

• Primary Outcome 1: Language Sample

  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 Outcomes (3)

• Secondary Aim 1: Joint Engagement

  Follow-Up; 8 months on average

• Secondary Outcome 2: Number of Unique Words (Vocabulary)

  Follow-Up; 8 months on average

• Secondary Outcome 3: Object Play

  Follow-Up; 8 months on average

Other Outcomes (3)

• Parent Training

  Follow-Up; 8 months on average

• Treatment Effects

  Follow-Up; 8 months on average

• Moderators

  Follow-Up; 8 months on average

Study Arms (2)

JASP-EMT

ACTIVE COMPARATOR

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

DTT

ACTIVE COMPARATOR

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

Interventions

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.

JASP-EMT

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.

DTT

Eligibility Criteria

• Age: 54 Months - 96 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of syndrome or degenerative disorder
• Poorly controlled seizures

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (22)

• 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.

  PMID: 18229990 BACKGROUND

• 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. doi: 10.1111/j.1469-7610.2005.01567.x.

  PMID: 16712638 BACKGROUND

• 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.

  PMID: 22744141 BACKGROUND

• 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.

  PMID: 22490620 BACKGROUND

• 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. doi: 10.1007/s10803-006-0173-3.

  PMID: 16897380 BACKGROUND

• 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. doi: 10.1007/s10803-005-0017-6.

  PMID: 16496206 BACKGROUND

• 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.

  PMID: 19372766 BACKGROUND

• Kidwell KM, Seewald NJ, Tran Q, Kasari C, Almirall D. Design and Analysis Considerations for Comparing Dynamic Treatment Regimens with Binary Outcomes from Sequential Multiple Assignment Randomized Trials. J Appl Stat. 2018;45:1628-1651. doi: 10.1080/02664763.2017.1386773. Epub 2017 Oct 12.

  PMID: 30555200 BACKGROUND

• Almirall D, Kasari C, McCaffrey DF, Nahum-Shani I. Developing Optimized Adaptive Interventions in Education. J Res Educ Eff. 2018;11(1):27-34. doi: 10.1080/19345747.2017.1407136. Epub 2017 Nov 29.

  PMID: 29552270 BACKGROUND

• Lu X, Nahum-Shani I, Kasari C, Lynch KG, Oslin DW, Pelham WE, Fabiano G, Almirall D. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med. 2016 May 10;35(10):1595-615. doi: 10.1002/sim.6819. Epub 2015 Dec 6.

  PMID: 26638988 BACKGROUND

• Kasari C. Update on behavioral interventions for autism and developmental disabilities. Curr Opin Neurol. 2015 Apr;28(2):124-9. doi: 10.1097/WCO.0000000000000185.

  PMID: 25695136 BACKGROUND

• Kasari C, Shire S, Shih W, Landa R, Levato L, Smith T. Spoken language outcomes in limited language preschoolers with autism and global developmental delay: RCT of early intervention approaches. Autism Res. 2023 Jun;16(6):1236-1246. doi: 10.1002/aur.2932. Epub 2023 Apr 18.

  PMID: 37070270 RESULT

• Sterrett K, Holbrook A, Landa R, Kaiser A, Kasari C. The effect of responsiveness to speech-generating device input on spoken language in children with autism spectrum disorder who are minimally verbaldagger. Augment Altern Commun. 2023 Mar;39(1):23-32. doi: 10.1080/07434618.2022.2120070. Epub 2022 Oct 20.

  PMID: 36267016 RESULT

• Toolan C, Holbrook A, Schlink A, Shire S, Brady N, Kasari C. Using the Clinical Global Impression scale to assess social communication change in minimally verbal children with autism spectrum disorder. Autism Res. 2022 Feb;15(2):284-295. doi: 10.1002/aur.2638. Epub 2021 Nov 19.

  PMID: 34800004 RESULT

• Harrop C, Sterrett K, Shih W, Landa R, Kaiser A, Kasari C. Short-term trajectories of restricted and repetitive behaviors in minimally verbal children with autism spectrum disorder. Autism Res. 2021 Aug;14(8):1789-1799. doi: 10.1002/aur.2528. Epub 2021 May 7.

  PMID: 33960125 RESULT

• Harrop C, Tu N, Landa R, Kasier A, Kasari C. Sensory Behaviors in Minimally Verbal Children With Autism Spectrum Disorder: How and When Do Caregivers Respond? Am J Intellect Dev Disabil. 2018 Jan;123(1):1-16. doi: 10.1352/1944-7558-123.1.1.

  PMID: 29281320 RESULT

• Kasari C, Sturm A, Shih W. SMARTer Approach to Personalizing Intervention for Children With Autism Spectrum Disorder. J Speech Lang Hear Res. 2018 Nov 8;61(11):2629-2640. doi: 10.1044/2018_JSLHR-L-RSAUT-18-0029.

  PMID: 30418492 RESULT

• Chang YC, Shih W, Landa R, Kaiser A, Kasari C. Symbolic Play in School-Aged Minimally Verbal Children with Autism Spectrum Disorder. J Autism Dev Disord. 2018 May;48(5):1436-1445. doi: 10.1007/s10803-017-3388-6.

  PMID: 29170936 RESULT

• Almirall D, DiStefano C, Chang YC, Shire S, Kaiser A, Lu X, Nahum-Shani I, Landa R, Mathy P, Kasari C. Longitudinal Effects of Adaptive Interventions With a Speech-Generating Device in Minimally Verbal Children With ASD. J Clin Child Adolesc Psychol. 2016 Jul-Aug;45(4):442-56. doi: 10.1080/15374416.2016.1138407. Epub 2016 Mar 8.

  PMID: 26954267 RESULT

• Kasari C, Kaiser A, Goods K, Nietfeld J, Mathy P, Landa R, Murphy S, Almirall D. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):635-46. doi: 10.1016/j.jaac.2014.01.019. Epub 2014 Mar 12.

  PMID: 24839882 RESULT

• Pizzano M, Shire S, Shih W, Levato L, Landa R, Lord C, Smith T, Kasari C. Profiles of minimally verbal autistic children: Illuminating the neglected end of the spectrum. Autism Res. 2024 Jun;17(6):1218-1229. doi: 10.1002/aur.3151. Epub 2024 May 27.

  PMID: 38803132 RESULT

• Kasari C, Shire S, Shih W, Kaiser A, Lord C, Levato L, Smith T, Almirall D. Adaptive Intervention for School-Age, Minimally Verbal Children With Autism Spectrum Disorder in the Community: Primary Aim Results. J Am Acad Child Adolesc Psychiatry. 2025 Jun;64(6):674-685. doi: 10.1016/j.jaac.2024.10.020. Epub 2025 Jan 24.

  PMID: 39864797 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (4)