Word Learning in Children With Autism

• ClinicalTrials.gov Identifier: NCT03419611
• Recruitment Status: Recruiting
• First Posted: February 2, 2018
• Last Update Posted: April 29, 2019
• Sponsor: University of Kansas
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): University of Kansas

Tracking Information

• First Submitted Date: January 26, 2018
• First Posted Date: February 2, 2018
• Last Update Posted Date: April 29, 2019
• Actual Study Start Date: November 1, 2016
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2018)

• Expressive Word Acquisition [ Time Frame: Week 1 ]
  The number of words each child learns to say.
• Change in Expressive Word Acquisition [ Time Frame: Week 16 ]
  The number of words each child learns to say.
• Receptive Word Acquisition [ Time Frame: Week 1 ]
  The number of words each child learns to understand.
• Change in Receptive Word Acquisition [ Time Frame: Week 16 ]
  The number of words each child learns to understand.

Original Primary Outcome Measures (submitted: January 26, 2018)

Word Acquisition [ Time Frame: 12 weeks ]

The number of words each child learns per condition.

• Change History: Complete list of historical versions of study NCT03419611 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 26, 2018)

• Communication Complexity Scale [ Time Frame: Week 1 ]
  Measure of Early Communication - The Communication Complexity Scale is a measure of communication complexity that describes expressive prelinguistic and beginning linguistic communication. The range is 0-12, with 0 indicating no response and 12 indicating a short phrase (2 or more words). Scores between 0-5 are preintentional; scores between 6-10 are intentional presymbolic; and scores 11 and 12 are intentional symbolic. Separate scores are computed for Behavior Regulation (requests and protests) and Joint Attention (Comments). Thus 3 different scores with a range of 0-12 are obtained- Overall, Behavior Regulation and Joint Attention.
• Change in Communication Complexity Scale [ Time Frame: Week 16 ]
  Measure of Early Communication - The Communication Complexity Scale is a measure of communication complexity that describes expressive prelinguistic and beginning linguistic communication. The range is 0-12, with 0 indicating no response and 12 indicating a short phrase (2 or more words). Scores between 0-5 are preintentional; scores between 6-10 are intentional presymbolic; and scores 11 and 12 are intentional symbolic. Separate scores are computed for Behavior Regulation (requests and protests) and Joint Attention (Comments). Thus 3 different scores with a range of 0-12 are obtained- Overall, Behavior Regulation and Joint Attention.

Original Secondary Outcome Measures (submitted: January 26, 2018)

• Vineland Adaptive Behavior Scale 3 [ Time Frame: Week 1 ]
  Standardized Test of Adaptive Behavior
• Communication Complexity Scale [ Time Frame: Week 1, Week 12 ]
  Measure of Early Communication
• Peabody Picture Vocabulary Test 4 [ Time Frame: Week 1 ]
  Standardized Test of Vocabulary
• Imitation Probe [ Time Frame: Week 1 ]
  Test of Verbal and Non-Verbal Imitation

Current Other Pre-specified Outcome Measures (submitted: June 26, 2018)

• Consonant Inventory [ Time Frame: Week 1 ]
  Number of Different Consonants
• Change in Consonant Inventory [ Time Frame: Week 16 ]
  Number of Different Consonants

Original Other Pre-specified Outcome Measures (submitted: January 26, 2018)

Consonant Inventory [ Time Frame: Week 1, Week 12 ]

Number of Different Consonants

Descriptive Information

• Brief Title: Word Learning in Children With Autism
• Official Title: Word Learning in Children With Autism (Kansas Intellectual and Developmental Disabilities Research Center Project I)
• Brief Summary: The project highlights one of the primary areas of research within the KIDDRC— language and communication. The focus is on language and communication in children with autism and minimal verbal skills (less than 20 spoken words). Remaining nonverbal past the age of 5 years has been considered a poor prognostic indicator for future language developments, yet few interventions have been developed to address this problem. The Specific Aims for this project are (1) to further investigate a multimodal intervention for school-age children with minimal verbal skills—defined as less than 20 words spontaneously spoken, signed, or selected via graphic symbol selection—and (2) to identify significant covariates associated with differential responding to the intervention. The research addresses an unmet need to promote spoken word production in children who remain essentially nonverbal well past the ages associated with speech acquisition. The project is also innovative because: a) it investigates a multimodal intervention based on principles of phonotactic probability and neighborhood density in combination with augmentative and alternative communication (AAC), and b) it investigates novel predictors of treatment response that are obtained through cutting-edge technologies. This intervention will have better success than past interventions because the intervention will provide increased input through speech, digitized speech and visual images and additional speech sound practice for words that are comprised of high frequency sounds in the child's repertoire. Extant speech sounds in each participant's repertoire will be identified using LENA™ digitized recordings. Vocabulary words will then be selected based on a child's speech sound repertoire and principles of word learning—words with high probability speech sound sequences will be selected and taught with either multimodal intervention or a treatment as usual condition. Responses to these interventions will be evaluated using a Sequential Multiple Assignment Randomized Trials (SMART) design. Different outcomes may be associated with individual and environmental predictors identified in our previous research. Individual predictors include verbal comprehension, imitation skills, adaptive behavior, nonverbal speech sound repertoire, and communication complexity. Communication complexity will be measured with the Communication Complexity Scale (CCS), developed by the Principal Investigator. Environmental predictors include language input to the child as measured with LENA™ recording devices. Results will determine if the multimodal intervention is more successful than treatment as usual for teaching word productions.

Detailed Description

Communication is an essential aspect of life for all individuals including children with autism. Many children with autism are severely impaired in their verbal communication development and there is a need for additional research demonstrating the effectiveness of interventions that improve communication for participants with autism and severe communication impairments. The proposed study directly follows from a recently published pilot study demonstrating both the feasibility and importance of an intervention designed for children with autism and minimal verbal skills (less than 20 words pre-intervention) (Brady et al., 2015). The project will follow up this pilot study with a two stage SMART (Sequential Multiple Assignment Randomized Trial) design that will allow comparison of results from an experimental intervention to a treatment as usual condition, and compare two intensities of multimodal intervention. Further, the project will investigate how proposed variables measured at the outset of intervention predict responsiveness to the treatment conditions.

Aim 1. Investigate the effectiveness of a multimodal intervention aimed at teaching students with autism and minimal verbal skills to produce new words with speech and augmentative communication (AAC). Briefly, the multimodal approach combines joint book reading, computerized instruction, and AAC. The AAC component teaches participants to select target words on speech generating devices in communication routines. All components will focus on teaching a set of vocabulary selected for each participant based on results from digitized recordings of sounds produced over a 12-hour time period. Target vocabulary will be one-syllable words that consist of sounds in each child's phonetic repertoire in sequences that are highly represented in the English language (i.e., high phonotactic probability) and determine if increasing intensity leads to better outcomes for participants who do not respond to the initial intervention. Increased intensity or regular multimodal intervention may be better for those who do not respond to treatment as usual. Primary outcome measures include:

• Total number of words each child learns to say and the number of words each child learns to produce with AAC during intervention.
• Total number of words each child says in generalization contexts. Generalization of word use to classrooms and at home will be measured with recordings from generalization probes conducted in homes and classrooms.

Aim 2. Investigate potential predictor variables for individual differences in learning outcomes measured in Aim 1. Results from Brady et al. (2015) showed 5 of 10 participants were "high responders" to multi-modal intervention - learning 18 or more new words over approximately 2 months of intervention. However, three participants learned to say only a few words and two participants essentially made no progress. The project will examine individual predictors of differential responding and identify variables that will enable clinicians to personalize intervention according to specific environmental and participant characteristics. The proposed predictor variables are:

• Environmental variables: Based on previous research linking the amount and type of environmental input to children's word acquisition, vocabulary input from parents and teachers will be measured with automated speech recognition technology. Existing technology available through LENA™ software (Warren et al., 2010) will be used to measure total number of words produced by communicative partners and conversational turns in home and school environments.
• Participant characteristics: Based on the pilot investigation as well as previous longitudinal studies, the following specific child variables are proposed to be predictive of responsiveness to one of the experimental interventions: verbal imitation, receptive vocabulary, adaptive behavior, autism severity, and nonverbal communication complexity measured with the Communication Complexity Scale (CCS; Brady et al., 2012).

Results will drive the development of more effective adaptive language interventions for minimally verbal children with autism and related intellectual and developmental disabilities.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Following the selection of target words based on sounds in the child's speech repertoire as described below, participants will be randomly assigned with equal probability to either the multimodal or TAU treatment in phase one. If data indicates a positive slope in the number of words correct in speech production probes and at least 2 words produced with > 80% accuracy, the participant will meet "responder" criterion, and continue in their originally assigned intervention. Participants who do not meet this criterion will be re-assigned to one of the stage 2 treatment conditions as depicted in figure 1. Participants who do not respond to the TAU will be randomly reassigned with equal probability to receive either the multimodal intervention or the high intensity multimodal intervention. Participants will continue in this second stage of intervention until 40 words have been learned or 12 weeks elapse (whichever occurs first).

Masking: Single (Outcomes Assessor)
Masking Description:

Coders will be blind to condition.

Primary Purpose: Treatment

• Condition: Autistic Disorders Spectrum

Intervention

• Behavioral: Multi-Modal
  Intervention combining speech sound practice, AAC and receptive practice on a set of individually determined words. Words are selected based on phonological properties. Delivered 3 times per week.
• Other: Treatment as Usual
  Teacher provided with word list and teacher intervening as usual.
• Behavioral: High Intensity Multi-Modal
  Intervention combining speech sound practice, AAC and receptive practice on a set of individually determined words. Words are selected based on phonological properties. Delivered 5 times per week.

Study Arms

• Experimental: Multi-Modal
  3 Times Per Week for 4 weeks - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component followed by more treatment for 12 weeks
  Intervention: Behavioral: Multi-Modal
• Experimental: Multi-Modal + High Intensity Multi-Modal
  3 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 4 weeks, increasing to 5 times per week for 12 weeks
  Interventions:

  • Behavioral: Multi-Modal
  • Behavioral: High Intensity Multi-Modal
• Placebo Comparator: Treatment as Usual
  Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks
  Intervention: Other: Treatment as Usual
• Experimental: Treatment as Usual + Multi-Modal
  Teacher provided with word list for 4 weeks followed by 3 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 12 weeks
  Interventions:

  • Behavioral: Multi-Modal
  • Other: Treatment as Usual
• Experimental: Treatment as Usual + High Intensity Multi-Modal
  Teacher provided with word list for 4 weeks followed by Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 5 times per week for 12 weeks
  Interventions:

  • Other: Treatment as Usual
  • Behavioral: High Intensity Multi-Modal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 26, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2021
• Estimated Primary Completion Date: May 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Autism Diagnosis
• Communication Disorder(s)

Exclusion Criteria:

• Deafness
• Severe Physical Disability

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 10 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nancy C Brady, PhD; 785-864-0762; nbrady@ku.edu

Contact: Holly M Storkel, PhD; 785-864-0630; hstorkel@ku.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03419611
• Other Study ID Numbers: STUDY00140285; U54HD090216 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Results submitted to National Database for Autism Research (NDAR)
• Supporting Materials: Study Protocol
• Time Frame: Annually
• Access Criteria: Access to NDAR
• URL: https://ndar.nih.gov/

• Responsible Party: University of Kansas
• Study Sponsor: University of Kansas
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Not Provided
• PRS Account: University of Kansas
• Verification Date: April 2019