Autistic Disorders SpectrumNCT03419611
Word Learning in Children With Autism
A study testing Multi-Modal, Treatment as Usual and High Intensity Multi-Modal in people with Autistic Disorders Spectrum, run by University of Kansas at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Autistic Disorders Spectrum
- What is being tested?
- Multi-Modal, Treatment as Usual and High Intensity Multi-Modal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism Diagnosis
- Communication Disorder(s)
Who cannot join
- Deafness
- Severe Physical Disability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas
Lawrence, Kansas, 66045
Nancy C Brady, PhD, 785-864-0762, nbrady@ku.edu
Stephanie Becker, 785-864-2487, sdbecker@ku.edu
About this study
Official title: Word Learning in Children With Autism (Kansas Intellectual and Developmental Disabilities Research Center Project I)
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.
- Conditions
- Autistic Disorders Spectrum
- Being tested
- Multi-Modal, Treatment as Usual, High Intensity Multi-Modal
- Keywords
- Communication Intervention
- Medical subject headings
- Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-ModalBehavioural
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.
Treatment as UsualOther
Teacher provided with word list and teacher intervening as usual.
High Intensity Multi-ModalBehavioural
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 group | Role | What they receive |
|---|---|---|
| Multi-Modal | Experimental | 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 Receives: Behavioral: Multi-Modal |
| Multi-Modal + High Intensity Multi-Modal | Experimental | 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 Receives: Behavioral: Multi-Modal; Behavioral: High Intensity Multi-Modal |
| Treatment as Usual | Placebo comparator | Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks Receives: Other: Treatment as Usual |
| Treatment as Usual + Multi-Modal | Experimental | 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 Receives: Behavioral: Multi-Modal; Other: Treatment as Usual |
| Treatment as Usual + High Intensity Multi-Modal | Experimental | 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 Receives: Other: Treatment as Usual; Behavioral: High Intensity Multi-Modal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressive Word Acquisition
The number of words each child learns to say.
Measured: Week 1
Change in Expressive Word Acquisition
The number of words each child learns to say.
Measured: Week 16
Receptive Word Acquisition
The number of words each child learns to understand.
Measured: Week 1
Change in Receptive Word Acquisition
The number of words each child learns to understand.
Measured: Week 16
Secondary outcomes (2)
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.
Measured: Week 1
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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Nov 2016
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Disorders SpectrumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419611
- Sponsor's protocol ID
- STUDY00140285
- Other IDs
- U54HD090216
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2018
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results submitted to National Database for Autism Research (NDAR)
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Word Learning in Children With Autism (Kansas Intellectual and Developmental Disabilities Research Center Project I)
- ClinicalTrials.gov ID
- NCT03419611
- Acronym / sponsor ID
- STUDY00140285
- Conditions
- Autistic Disorders Spectrum
- Keywords
- Communication Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- 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).
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal | Experimental | Behavioral: Multi-Modal3 Times Per Week for 4 weeks - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component followed by more treatment for 12 weeks |
| Multi-Modal + High Intensity Multi-Modal | Experimental | Behavioral: Multi-Modal, Behavioral: High Intensity Multi-Modal3 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 |
| Treatment as Usual | Placebo comparator | Other: Treatment as UsualTeacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks |
| Treatment as Usual + Multi-Modal | Experimental | Behavioral: Multi-Modal, Other: Treatment as UsualTeacher 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 |
| Treatment as Usual + High Intensity Multi-Modal | Experimental | Other: Treatment as Usual, Behavioral: High Intensity Multi-ModalTeacher 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 |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Autism Diagnosis
- Communication Disorder(s)
Key exclusion criteria (2 listed)
- Deafness
- Severe Physical Disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-ModalIntervention 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. | Behavioural | Multi-Modal, Multi-Modal + High Intensity Multi-Modal, Treatment as Usual + Multi-Modal |
| Treatment as UsualTeacher provided with word list and teacher intervening as usual. | Other | Treatment as Usual, Treatment as Usual + High Intensity Multi-Modal, Treatment as Usual + Multi-Modal |
| High Intensity Multi-ModalIntervention 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. | Behavioural | Multi-Modal + High Intensity Multi-Modal, Treatment as Usual + High Intensity Multi-Modal |
Primary outcome
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.
2 secondary outcomes
Communication Complexity Scale
Time frame: Week 1
Change in Communication Complexity Scale
Time frame: Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: Yes. Results submitted to National Database for Autism Research (NDAR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Modal, Treatment as Usual and High Intensity Multi-Modal in people with Autistic Disorders Spectrum, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy C Brady, PhD (785-864-0762, nbrady@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressive Word Acquisition (time frame: Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.