Word Learning in Children With Autism

NCT03419611 | Unknown DMC

• 2 other identifiers: STUDY00140285U54HD090216
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Communication Intervention

Outcome Measures

Primary Outcomes (4)

• Expressive Word Acquisition

  The number of words each child learns to say.

  Week 1

• Change in Expressive Word Acquisition

  The number of words each child learns to say.

  Week 16

• Receptive Word Acquisition

  The number of words each child learns to understand.

  Week 1

• Change in Receptive Word Acquisition

  The number of words each child learns to understand.

  Week 16

Secondary Outcomes (2)

• Communication Complexity Scale

  Week 1

• Change in Communication Complexity Scale

  Week 16

Other Outcomes (2)

• Consonant Inventory

  Week 1

• Change in Consonant Inventory

  Week 16

Study Arms (5)

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

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

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

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

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

Other: Treatment as Usual; Behavioral: High Intensity Multi-Modal

Interventions

Multi-Modal BEHAVIORAL

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.

Multi-Modal; Multi-Modal + High Intensity Multi-Modal; Treatment as Usual + Multi-Modal

Treatment as Usual OTHER

Teacher provided with word list and teacher intervening as usual.

Treatment as Usual; Treatment as Usual + High Intensity Multi-Modal; Treatment as Usual + Multi-Modal

High Intensity Multi-Modal BEHAVIORAL

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.

Multi-Modal + High Intensity Multi-Modal; Treatment as Usual + High Intensity Multi-Modal

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Autism Diagnosis
• Communication Disorder(s)

You may not qualify if:

• Deafness
• Severe Physical Disability

Sponsors & Collaborators

• University of Kansas: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

RECRUITING

MeSH Terms

Conditions

Child Development Disorders, Pervasive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Nancy C Brady, PhD

CONTACT

785-864-0762; nbrady@ku.edu

Holly M Storkel, PhD

CONTACT

785-864-0630; hstorkel@ku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Coders will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 5, 2018
• Study Start: November 1, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Annually
• Access Criteria: Access to NDAR

Locations

US (1)