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
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.
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.
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.
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 →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.
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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.
Scores at or below 10th percentile on at least one of these three vocabulary assessments:
Exclusion Criteria:
Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session.
Behavioral: Word Learning Intervention
Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session.
Behavioral: Word 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).
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
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
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
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
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
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)
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.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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