CClinicalTrials.gg
Status unknownNCT03419611Updated Apr 29, 2019

Word Learning in Children With Autism

An interventional study of Multi-Modal and Treatment as Usual in Autistic Disorders Spectrum, sponsored by University of Kansas. Status unknown at 1 site in United States. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by University of Kansas · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autistic Disorders Spectrum

Keywords

  • Communication Intervention
03

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Autism Diagnosis
  • Communication Disorder(s)

Exclusion criteria

Exclusion Criteria:

  • Deafness
  • Severe Physical Disability
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

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

    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

    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

    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

    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

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

Interventions

  • BehavioralMulti-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.

  • OtherTreatment as Usual

    Teacher provided with word list and teacher intervening as usual.

  • BehavioralHigh 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.

05

What researchers measure

Primary outcomes

  1. Expressive Word Acquisition

    The number of words each child learns to say.

    Time frame: Week 1

  2. Change in Expressive Word Acquisition

    The number of words each child learns to say.

    Time frame: Week 16

  3. Receptive Word Acquisition

    The number of words each child learns to understand.

    Time frame: Week 1

  4. Change in Receptive Word Acquisition

    The number of words each child learns to understand.

    Time frame: Week 16

Secondary outcomes

  1. Communication Complexity Scale

    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.

    Time frame: Week 1

  2. Change in Communication Complexity Scale

    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.

    Time frame: Week 16

Other outcomes

  1. Consonant Inventory

    Number of Different Consonants

    Time frame: Week 1

  2. Change in Consonant Inventory

    Number of Different Consonants

    Time frame: Week 16

06

Study locations

1 of 1 sites recruiting
  • University of Kansas
    Lawrence, Kansas 66045, United States
    • Nancy C Brady, PhD · Contact · nbrady@ku.edu · 785-864-0762
    • Stephanie Becker · Contact · sdbecker@ku.edu · 785-864-2487
    • Nancy C Brady, PhD · Principal investigator
    • Holly M Storkel, PhD · Sub investigator
    • Steven F Warren, PhD · Sub investigator
    Recruiting
07

References and documents

Study documents

  • Informed consent form · Mar 6, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Results submitted to National Database for Autism Research (NDAR)

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT03419611
Lead sponsor
University of Kansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Nov 1, 2016
Primary completion
May 31, 2021 (estimated)
Completion
May 31, 2021 (estimated)
Last update
Apr 29, 2019

Study contacts

Nancy C Brady, PhD
Contact
nbrady@ku.edu
785-864-0762
Holly M Storkel, PhD
Contact
hstorkel@ku.edu
785-864-0630

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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