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
Among 76 studies in Child Development Disorders, Pervasive with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Child Development Disorders, Pervasive · United States.
Among the 76 studies in Child Development Disorders, Pervasive with a site in United States, this one is the 23rd largest by planned enrollment of the 59 interventional ones, is one of 2 that started in 2016, is one of 26 with no phase, and was the 65th registered.
117 studies on the registry are indexed under Child Development Disorders, Pervasive; 15 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 85 interventional studies indexed under Child Development Disorders, Pervasive.
Browse Child Development Disorders, Pervasive studies →5 of the 76 studies in Child Development Disorders, Pervasive with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 8 Child Development Disorders, Pervasive studies recruiting now, 2 (25%) set no upper age limit and 6 (75%) stop at 75 or younger; 6 take children under 18; 1 take healthy volunteers.
This study: 5 Years to 10 Years · all sexes · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2016.
Median enrollment 44 across the 59 interventional studies, 130 across the 17 observational. Of the 60 that completed or were terminated, 23 (38%) have results posted.
4 of 76 have an industry lead sponsor. The 10 most frequent:
University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.
University of Kansas has 1 study filed under Child Development Disorders, Pervasive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 76 studies in Child Development Disorders, Pervasive with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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:
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:
Results will drive the development of more effective adaptive language interventions for minimally verbal children with autism and related intellectual and developmental disabilities.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Teacher provided with word list for 4 weeks followed by more treatment as usual for 12 weeks
Other: Treatment as Usual
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
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
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.
Teacher provided with word list and teacher intervening as usual.
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.
Expressive Word Acquisition
The number of words each child learns to say.
Time frame: Week 1
Change in Expressive Word Acquisition
The number of words each child learns to say.
Time frame: Week 16
Receptive Word Acquisition
The number of words each child learns to understand.
Time frame: Week 1
Change in Receptive Word Acquisition
The number of words each child learns to understand.
Time frame: Week 16
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
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
Consonant Inventory
Number of Different Consonants
Time frame: Week 1
Change in Consonant Inventory
Number of Different Consonants
Time frame: Week 16
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Results submitted to National Database for Autism Research (NDAR)
Supporting information: Study protocol
Time frame: Annually
Access criteria: Access to NDAR
Data sharing details ↗ · ndar.nih.gov
Started Nov 2016 (actual). Primary completion is estimated for May 2021, 54 months after the start.
Of 29 non-industry interventional studies with no phase under Child Development Disorders, Pervasive, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 64. This study's planned 54 months is above that.
Counting every sponsor, half of 30 studies reached it within 26 months; a quarter within 9 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Child Development Disorders, Pervasive →
University of Kansas