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NCT04501536 · ClinicalTrials.gov registry record · NA

Determining Optimal Treatment Intensity for Children With Language Impairment

A NA study, sponsored by University of Texas at Austin.

Completed
Registry status
NA
Development phase
59
Enrollment target

NCT04501536: Completed NA study, sponsored by University of Texas at Austin.

NCT04501536 is a NA study that has completed, run by University of Texas at Austin. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04501536, a NA study, has completed, sponsored by University of Texas at Austin.

COMPLETED
Registry status
NA
Development phase
59 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Word Learning Intervention

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2020-08-10
Est. Completion 2025-07-31
Phase NA
University of Texas at Austin

257 total trials

What the finished NCT04501536 record still lists

NCT04501536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Word Learning Intervention is the first listed.

NCT04501536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04501536 about?

NCT04501536 is a clinical study titled "Determining Optimal Treatment Intensity for Children With Language Impairment". 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 benef...

What is the current status of trial NCT04501536?

This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2020-08-10. Estimated completion is 2025-07-31.

What interventions are being tested in trial NCT04501536?

The interventions under investigation include: Word Learning Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04501536?

This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04501536's enrollment target sits among peer trials

59 1256th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04501536, the US trial registry maintained by the National Library of Medicine. NCT04501536 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.