Adaptive Interventions for Minimally Verbal Children With ASD in the Community

Autism Clinical Trial

— AIM-ASD  

Official title:

Adaptive Interventions for Minimally Verbal Children With ASD in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751698
• Other study ID #: R01HD073975
• Secondary ID: R01HD073975
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 54 Months to 96 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Rochester	Rochester	New York
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (21)

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 — View Citation

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. — View Citation

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. — View Citation

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 Ma — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Child Psychol Psychiatry. 2007 May;48(5):523. — View Citation

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):6 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 May 27. doi: 10.1002/aur.3151. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parent Training	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.	Follow-Up; 8 months on average
Other	Treatment Effects	To compare and contrast four pre-specified adaptive interventions in terms of primary and secondary outcomes.	Follow-Up; 8 months on average
Other	Moderators	To determine whether (a) baseline repetitive behavior, (b) baseline object interest, and (c) parent expectations for the specific intervention moderate intervention outcomes.	Follow-Up; 8 months on average
Primary	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	Secondary Aim 1: Joint Engagement	To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in symbol-infused joint engagement.	Follow-Up; 8 months on average
Secondary	Secondary Outcome 2: Number of Unique Words (Vocabulary)	To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in number of unique words.	Follow-Up; 8 months on average
Secondary	Secondary Outcome 3: Object Play	To determine which intervention for minimally verbal children (JASP-EMT vs. CORE-DTT) produces greater increases in object play level.	Follow-Up; 8 months on average