Recruiting

Multimodal Intervention

Sponsor:

University of Kansas

Code:

NCT03419611

Conditions

Autistic Disorders Spectrum

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Not accepted

Interventions

Multi-Modal

Treatment as Usual

High Intensity Multi-Modal

Study Details

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.

Conditions

Autistic Disorders Spectrum

Study ID

NCT03419611

Start date

Nov 1, 2016

Status verified date

Apr, 2019

Completion date

May 31, 2021

Anticipated

Primary completion date

May 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Autism Diagnosis
  • Communication Disorder(s)

Exclusion Criteria:

  • Deafness
  • Severe Physical Disability

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

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

placebo comparator: Treatment as Usual

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

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

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

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.

Treatment as Usual

Teacher provided with word list and teacher intervening as usual.

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.

Primary outcome measure

  • Expressive Word Acquisition [ Time Frame: Week 1 ]
  • Change in Expressive Word Acquisition [ Time Frame: Week 16 ]
  • Receptive Word Acquisition [ Time Frame: Week 1 ]
  • Change in Receptive Word Acquisition [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Nancy C Brady, PhD

785-864-0762nbrady@ku.edu

Holly M Storkel, PhD

785-864-0630hstorkel@ku.edu

Locations

University of Kansas

Recruiting

Lawrence, Kansas, United States, 66045

Contacts

Principal Investigator:

Nancy C Brady, PhD

More Information

Sponsor

University of Kansas

Last update posted

Apr 29, 2019

Last verified

Apr, 2019

Keywords

  • Communication Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas on 2019-04-29.