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Word Learning in Children With Autism

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ClinicalTrials.gov Identifier: NCT03419611
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Kansas

Brief Summary:
Our project highlights one of the primary areas of research within the Kansas Intellectual and Developmental Research Center— language and communication. Specifically, we focus 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 (Picket et al., 2009), 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. We propose that this intervention will have better success than past interventions because we 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 our multimodal intervention or a treatment as usual condition. Responses to these interventions will be evaluated using a Sequential Multiple Assignment Randomized Trials (SMART) design. We propose that different outcomes will 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 our multimodal intervention is more successful than treatment as usual for teaching word productions, but will also identify the individual and environmental profiles associated with differential outcomes. Our discoveries will lead to more focused clinical trial research and will inform customized intervention practices in schools and clinics. Ultimately this line of research aims to improve the lives of children with autism and their families through enhanced communication skills.

Condition or disease Intervention/treatment Phase
Autistic Disorders Spectrum Behavioral: Multi-Modal Other: Treatment as Usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Coders will be blind to condition.
Primary Purpose: Treatment
Official Title: Word Learning in Children With Autism (Kansas Intellectual and Developmental Disabilities Research Center Project I)
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multi-Modal
3 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 16 weeks
Behavioral: 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.

Experimental: Multi-Modal + High Intensity
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
Intervention combining speech sound practice, AAC and receptive practice on a set of individually determined words. Words are selected based on phonological properties.

Placebo Comparator: 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
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

Experimental: Treatment as Usual + Multi-Modal
Teacher provided with word list for 4 weeks followed by 5 Times Per Week - Speech sound practice, Joint book reading, AAC activity, Computerized instruction component for 12 weeks
Behavioral: 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.




Primary Outcome Measures :
  1. Word Acquisition [ Time Frame: 12 weeks ]
    The number of words each child learns per condition.


Secondary Outcome Measures :
  1. Vineland Adaptive Behavior Scale 3 [ Time Frame: Week 1 ]
    Standardized Test of Adaptive Behavior

  2. Communication Complexity Scale [ Time Frame: Week 1, Week 12 ]
    Measure of Early Communication

  3. Peabody Picture Vocabulary Test 4 [ Time Frame: Week 1 ]
    Standardized Test of Vocabulary

  4. Imitation Probe [ Time Frame: Week 1 ]
    Test of Verbal and Non-Verbal Imitation


Other Outcome Measures:
  1. Consonant Inventory [ Time Frame: Week 1, Week 12 ]
    Number of Different Consonants



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autism Diagnosis
  • Communication Disorder(s)

Exclusion Criteria:

  • Deafness
  • Severe Physical Disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419611


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

Locations
United States, Kansas
University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Nancy C Brady, PhD    785-864-0762    nbrady@ku.edu   
Contact: Stephanie Becker    785-864-2487    sdbecker@ku.edu   
Principal Investigator: Nancy C Brady, PhD         
Sub-Investigator: Holly M Storkel, PhD         
Sub-Investigator: Steven F Warren, PhD         
Sponsors and Collaborators
University of Kansas
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT03419611     History of Changes
Other Study ID Numbers: STUDY00140285
U54HD090216 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results submitted to National Database for Autism Research (NDAR)
Supporting Materials: Study Protocol
Time Frame: Annually
Access Criteria: Access to NDAR
URL: https://ndar.nih.gov/

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas:
Communication Intervention

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders