Language ImpairmentNCT04501536
Determining Optimal Treatment Intensity for Children With Language Impairment
A study testing Word Learning Intervention in people with Language Impairment, run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Language Impairment
- What is being tested?
- Word Learning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Children with concomitant diagnoses that may underlie observed language difficulties (e.g., autism, hearing loss, severe cognitive disability)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas at Austin
Austin, Texas, 78712
The Ohio State University
Columbus, Ohio, 43210
About this study
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.
Read more
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.
- 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.
- 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.
- 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.
- Conditions
- Language Impairment
- Being tested
- Word Learning Intervention
- Keywords
- Dose, Frequency, Vocabulary, Treatment Intensity, Intensity
- Medical subject headings
- Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Word Learning InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| High Frequency | Experimental | Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session. Receives: Behavioral: Word Learning Intervention |
| Low Frequency | Experimental | Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session. Receives: Behavioral: Word Learning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 6 months after the last intervention session
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.
Measured: Within 2 weeks of the last intervention session
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.
Measured: 6 months after the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Aug 2020
- Primary completion9 Jan 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Mary Beth Schmitt, University of Texas at Austin
- Investigators
- Mary Beth Schmitt, PhD, Principal investigator, The University of Texas at AustinLaura Justice, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501536
- Sponsor's protocol ID
- 2019-09-0029
- Status last verified
- Oct 2025
- First submitted
- 29 Jul 2020
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Treatment Intensity for Children With Language Impairment
- ClinicalTrials.gov ID
- NCT04501536
- Acronym / sponsor ID
- 2019-09-0029
- Conditions
- Language Impairment
- Keywords
- Dose, Frequency, Vocabulary, Treatment Intensity, Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Frequency | Experimental | Behavioral: Word Learning InterventionParticipants will receive therapy 4 times a week for 10 weeks for 30 minutes per session. |
| Low Frequency | Experimental | Behavioral: Word Learning InterventionParticipants will receive therapy 1 time a week for 10 weeks for 2 hours per session. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- Children with concomitant diagnoses that may underlie observed language difficulties (e.g., autism, hearing loss, severe cognitive disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Word Learning InterventionThe 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). | Behavioural | High Frequency, Low Frequency |
Primary outcome
Change in Definition Task
Time frame: Within 2 weeks of the last intervention session
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.
Generalized Change in Definition Task
Time frame: 6 months after the last intervention session
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.
4 secondary outcomes
Change in Word Definition Task Expressive One-Word Picture Vocabulary Test -Fourth Edition (EOWPVT-4); Standardized
Time frame: 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
Time frame: 6 months after the last intervention session
Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized
Time frame: Within 2 weeks of the last intervention session
Generalized Change in Receptive One-Word Picture Vocabulary Test-Fourth Edition (ROWPVT-4); Standardized
Time frame: 6 months after the last intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Beth Schmitt, PhD principal investigator
The University of Texas at Austin
Laura Justice, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Word Learning Intervention in people with Language Impairment, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Definition Task (time frame: Within 2 weeks of the last intervention session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.