Determining Optimal Treatment Intensity for Children With Language Impairment

NCT04501536 | Completed DMC

• 1 other identifier: 2019-09-0029
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the amount of speech-language intervention children with language impairment need to make vocabulary gains. The investigators hope to identify the optimal amount of intervention needed as well as the point at which adding more intervention is no longer beneficial. Participants will be randomly assigned (like a flip of a coin) to attend therapy either one time a week for 10 weeks (2 hours a session) or 4 times a week for 10 weeks (30 min per session). Each therapy session will follow a word learning intervention that is designed to increase children's word learning abilities using rich, robust word learning strategies within story book readings. The optimal amount of intervention relates to duration, dose, and frequency. Duration refers to how long the child is seen for (e.g., 10 weeks, 1 year). Dose represents the number of exposures to each new vocabulary word within a therapy session. Frequency represents the number of therapy sessions per week. The investigators will test the hypothesis that distributed learning leads to higher gains. The investigators propose that the greatest gains will be observed for children who receive high-frequency/low-dose or low-frequency/high-dose treatments as compared to children who receive high-frequency/high-dose or low-frequency/low-dose treatments. The investigators will test the hypothesis that for both low-frequency and high-frequency treatments, there is a point at which increases in treatment dose do not correspond to any additional gains in children's vocabulary skills during treatment. At the close of this four-year study, evidence concerning optimal treatment intensity of a word learning intervention will be instrumental for immediately informing speech-language pathologists in how much vocabulary treatment to prescribe as well as for designing additional clinical trials by our and other research teams.

Conditions

Language Impairment

Keywords

Dose; Frequency; Vocabulary; Treatment Intensity; Intensity

Outcome Measures

Primary Outcomes (2)

• Change in Definition Task

  The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.

  Within 2 weeks of the last intervention session

• Generalized Change in Definition Task

  The definition task assesses children's abilities to define the 60 intervention target words. To administer the definition task, children are shown a picture representing each targeted word and asked to define it.

  6 months after the last intervention session

Secondary Outcomes (4)

• Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized

  Within 2 weeks of the last intervention session

• Generalized Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized

  6 months after the last intervention session

• Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized

  Within 2 weeks of the last intervention session

• Generalized Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized

  6 months after the last intervention session

Study Arms (2)

High Frequency

EXPERIMENTAL

Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session.

Behavioral: Word Learning Intervention

Low Frequency

EXPERIMENTAL

Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session.

Behavioral: Word Learning Intervention

Interventions

Word Learning Intervention BEHAVIORAL

The word learning intervention uses the 10 commercially available children's books and 6 target vocabulary words from each book that meet common criteria for appropriate vocabulary targets. Children will receive 1-on-1 treatment sessions with a trained, speech-language research assistant. Each week, 2 of 10 storybooks chosen for the study will be read with 3 of 6 targeted vocabulary words targeted from each book. The book and words targeted will be consistent between random assignment conditions. For each book reading, speech-language interns will implement word learning strategies during pre reading, during reading, and post reading. Strategies include providing a definition, a synonym, and a contextual sentence. The number of strategies used will vary on which word is being targeted; all words will be randomly assigned to a particular dose, ranging from 0 (no strategies) to 20 (all of the strategies at each reading).

High Frequency; Low Frequency

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is between the ages of 5:0-8:11
• Has a primary diagnosis of a language impairment with deficits in vocabulary
• Primarily communicates in English
• Scores at or below 10th percentile on at least one of these three vocabulary assessments:
• Semantics subtest of the Diagnostic Evaluation of Language Variation (DELV)
• Vocabulary subtests of the Test of Language Development (TOLD-P:5); or
• Comprehensive Receptive and Expressive Vocabulary (CREVT)

You may not qualify if:

• Children with concomitant diagnoses that may underlie observed language difficulties (e.g., autism, hearing loss, severe cognitive disability)

Sponsors & Collaborators

• University of Texas at Austin: lead
• Ohio State University: collaborator

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

• Citations associated with the original grant/study protocol

MeSH Terms

Conditions

Language Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Beth Schmitt, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Laura Justice, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: August 10, 2020
• Primary Completion: January 9, 2025
• Study Completion: July 31, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data and supporting information will be available one year after the study completion (1/31/2025) for 5 years.
• Access Criteria: Researchers interested in our data or supporting documents should contact the PI: Dr. Mary Beth Schmitt (see contact information)

Locations

US (2)