ClinicalTrials.gg
CompletedNCT04501536Updated Oct 28, 2025

Determining Optimal Treatment Intensity for Children With Language Impairment

An interventional study of Word Learning Intervention in Language Impairment, sponsored by University of Texas at Austin. Completed at 2 sites in United States. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-10-28.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

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.

Read the detailed description

The purpose of this study is to determine the optimal treatment intensity of a word learning intervention for improved measures of vocabulary immediately post intervention and at 6-months follow up by addressing 3 specific aims.

  1. to determine whether low frequency (massed) or high frequency (distributed) conditions are more effective intervention schedules with respect to children's vocabulary gains during treatment. Using a causally interpretable research design with children randomly assigned to both conditions, the investigators will test the hypothesis that high frequency treatment will be more effective than low frequency schedules, informed from our own research as well as that proposed by distributed learning theorists. The investigators propose that the greatest gains will be observed immediately post intervention as well as 6-months post intervention for children who receive high-frequency treatment as compared to children who receive low-frequency treatment.
  2. to determine the optimal number of dose exposures within each condition of frequency. Using a causally interpretable research design, with planned variations in dose, the investigators will test the hypothesis that increases in dose are beneficial when treatment frequency is low, and similarly that low levels of dose are beneficial when frequency is high. 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.
  3. to identify thresholds of cumulative intensity after which additional exposures provide no additional benefit to children's vocabulary gains, corresponding to a point of 'diminishing returns'. 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.

The proposed study features a two-group pre/post experimental design with random assignment to target words across six dose exposures. Using blocked random assignment, each child will first be randomized to a low-or high-frequency treatment condition. Target words will then be randomly assigned to one of six dose exposures (0, 4, 8, 12, 16, 20 with 0 serving as a control). Thus, this study will measure both between child (frequency) and within child (dose) variance attributed to intensity of treatment. Children who meet all eligibility criteria and are enrolled in the study will be randomly assigned to one of the two conditions, high-or low-frequency, as previously described.

Each child will receive one-on-one treatment sessions each week for 10 weeks according to their assigned frequency (one or four sessions per week for a total of 10 or 40 sessions, respectively) over the summer period. Each session will follow an efficacious word learning intervention. The word learning intervention uses the 10 commercially available children's books from previous studies. Each week, 2 of the 10 storybooks will be read, with 3 of the 6 vocabulary words targeted from each book. The book and words targeted will be consistent between frequency conditions. For the high-frequency condition, each book will be read once per session across 4 sessions, for a total of 4 readings per book each week. For the low-frequency condition, each book will be read 4 times in 1 session for a total of 4 readings per book each week, thereby keeping the number of book-readings equal across conditions. Over the course of the 10-week intervention, two books will be read each week and all 10 books will be read twice throughout the intervention. Three of the 6 targeted words will be taught the first week the book is read and the other 3 of 6 targeted words taught the second week the book is read. Each child will receive a total of 120 minutes of therapy each week, which equates to 14-16 hours of therapy (approximately 4 hours of therapy per day for 4 days).

The word learning intervention is designed to increase children's word learning abilities using rich, robust word learning strategies within story book readings including provision of a synonym (e.g., A furnace is like a heater), definition (e.g., Furnace means something used to make heat to warm buildings), and context sentence (e.g., Today it was cold outside so mom turned on the furnace) during pre-book reading, book reading, and post-book reading activities. During the pre-book reading, the intern will discuss the target words that the child will hear in the book, with the exception of the word assigned to the 0 exposure condition. During this portion of the intervention, the speech-language intern will use zero, one or two strategies, depending on the assigned dose. During the book reading portion of the intervention, the intern will read the book in its entirety. The intern will either not elaborate the target word (0 dose) or will offer a synonym as the word is read in the book. During the post-book reading, the intern will use zero, one, or two strategies depending on the assigned dose.

02

Conditions studied

  • Language Impairment

Browse trials for

Keywords

  • Dose
  • Frequency
  • Vocabulary
  • Treatment Intensity
  • Intensity
03

In context

Language Disorders

84 studies on the registry are indexed under Language Disorders; 18 are open to participants now.

This study's enrollment of 59 is above the median of 51 across 66 interventional studies indexed under Language Disorders.

Browse Language Disorders studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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:

    1. Semantics subtest of the Diagnostic Evaluation of Language Variation (DELV)
    2. Vocabulary subtests of the Test of Language Development (TOLD-P:5); or
    3. Comprehensive Receptive and Expressive Vocabulary (CREVT)

Exclusion criteria

Exclusion Criteria:

  • Children with concomitant diagnoses that may underlie observed language difficulties (e.g., autism, hearing loss, severe cognitive disability)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    High Frequency

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

    Behavioral: Word Learning Intervention

  • Experimental
    Low Frequency

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

    Behavioral: Word Learning Intervention

Interventions

  • BehavioralWord Learning Intervention

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 2 weeks of the last intervention session

  2. 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.

    Time frame: 6 months after the last intervention session

Secondary outcomes

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

    The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.

    Time frame: Within 2 weeks of the last intervention session

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

    The EOWPVT-4 is an individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures.

    Time frame: 6 months after the last intervention session

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

    The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.

    Time frame: Within 2 weeks of the last intervention session

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

    The ROWPVT-4 is an individually administered, norm-referenced assessment of how well a person can match a word that is heard to objects, actions, or concepts presented in pictures.

    Time frame: 6 months after the last intervention session

07

Study locations

2 sites
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • University of Texas at Austin
    Austin, Texas 78712, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — We would not release protected information specific to individual participants, but will share de-identified study data and protocols with other researchers who could use the data to advance knowledge of treatment processes for children with language impairment.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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)

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Jan 2025, 52 months.

Of 35 non-industry interventional studies with no phase under Language Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 52 months is above that.

Counting every sponsor, half of 36 studies reached it within 27 months; a quarter within 9 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2020
First posted
Aug 6, 2020
StartActual
Aug 10, 2020
Primary completionActual
Jan 9, 2025
CompletionActual
Jul 31, 2025
Last update
Oct 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04501536
Responsible party
Mary Beth Schmitt (Assistant Professor, University of Texas at Austin) — Principal investigator
First posted
Aug 6, 2020
Start date
Aug 10, 2020
Primary completion
Jan 9, 2025
Completion
Jul 31, 2025
Last update
Oct 28, 2025

Study contacts

Mary Beth Schmitt, PhD
principal investigator · The University of Texas at Austin
Laura Justice, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion