search
Back to results

Word Learning in Children With Autism

Primary Purpose

Autistic Disorders Spectrum

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Modal
Treatment as Usual
High Intensity Multi-Modal
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorders Spectrum focused on measuring Communication Intervention

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Autism Diagnosis
  • Communication Disorder(s)

Exclusion Criteria:

  • Deafness
  • Severe Physical Disability

Sites / Locations

  • University of KansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Multi-Modal

Multi-Modal + High Intensity Multi-Modal

Treatment as Usual

Treatment as Usual + Multi-Modal

Treatment as Usual + High Intensity Multi-Modal

Arm Description

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

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

Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks

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

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

Outcomes

Primary Outcome Measures

Expressive Word Acquisition
The number of words each child learns to say.
Change in Expressive Word Acquisition
The number of words each child learns to say.
Receptive Word Acquisition
The number of words each child learns to understand.
Change in Receptive Word Acquisition
The number of words each child learns to understand.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 26, 2018
Last Updated
April 25, 2019
Sponsor
University of Kansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03419611
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorders Spectrum
Keywords
Communication Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Outcomes Assessor
Masking Description
Coders will be blind to condition.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Modal
Arm Type
Experimental
Arm Description
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
Arm Title
Multi-Modal + High Intensity Multi-Modal
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks
Arm Title
Treatment as Usual + Multi-Modal
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual + High Intensity Multi-Modal
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Multi-Modal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Teacher provided with word list and teacher intervening as usual.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Multi-Modal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expressive Word Acquisition
Description
The number of words each child learns to say.
Time Frame
Week 1
Title
Change in Expressive Word Acquisition
Description
The number of words each child learns to say.
Time Frame
Week 16
Title
Receptive Word Acquisition
Description
The number of words each child learns to understand.
Time Frame
Week 1
Title
Change in Receptive Word Acquisition
Description
The number of words each child learns to understand.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Communication Complexity Scale
Description
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
Title
Change in Communication Complexity Scale
Description
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 Pre-specified Outcome Measures:
Title
Consonant Inventory
Description
Number of Different Consonants
Time Frame
Week 1
Title
Change in Consonant Inventory
Description
Number of Different Consonants
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Autism Diagnosis Communication Disorder(s) Exclusion Criteria: Deafness Severe Physical Disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy C Brady, PhD
Phone
785-864-0762
Email
nbrady@ku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Holly M Storkel, PhD
Phone
785-864-0630
Email
hstorkel@ku.edu
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy C Brady, PhD
Phone
785-864-0762
Email
nbrady@ku.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Becker
Phone
785-864-2487
Email
sdbecker@ku.edu
First Name & Middle Initial & Last Name & Degree
Nancy C Brady, PhD
First Name & Middle Initial & Last Name & Degree
Holly M Storkel, PhD
First Name & Middle Initial & Last Name & Degree
Steven F Warren, PhD

12. IPD Sharing Statement

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

Learn more about this trial

Word Learning in Children With Autism

We'll reach out to this number within 24 hrs