Language Disorders in ChildrenNCT06250101
Training Grammar With Meaning
A study testing Enhanced Conversational Recast treatment in people with Language Disorders in Children, run by University of Arizona at 1 site in United States.
Trial summary
This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Read more about this study
- Who is it for?
- Ages 48 to 83 months
- Conditions the study is for
- Language Disorders in Children
- What is being tested?
- Enhanced Conversational Recast treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning
Who cannot join
- hearing loss Intellectual disability Other handicapping conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 5: Effects of Semantic Support
This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. Children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.
Read the detailed description
Children between 4 years, 0 months and 6 years 11 months are eligible. A diagnosis of developmental language disorders will be confirmed as normal nonverbal cognitive function, passing a pure-tone audiometric screening, and a test score consistent with developmental language disorder on a standardized language test, and parent report of no other diagnosed handicapping condition. Speech skills and vocabulary skills will be described via standardized testing.
Children enrolled in treatment are seen for up to 28 consecutive weekdays. The study starts with three days of baseline assessment of morpheme use for potential treatment targets. Two are selected for study, with one treated and one tracked over the course of treatment. Treatment is embedded in child-friendly activities like games, book reading, and craft activities. Children are prompted to use the treated morpheme in conversation. Immediately following this attempt, the treating clinician repeats the child's utterance, correcting any ungrammatical forms. Half of the children will also receive explanations of what the key words in sentences mean (e.g., to twirl means to turn around fast). Generalization to untreated contexts is assessed 2-3 times weekly. Retention of learning is measured about six weeks after the end of treatment.
- Conditions
- Language Disorders in Children
- Being tested
- Enhanced Conversational Recast treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Conversational Recast treatmentBehavioural
In the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment. The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements. Clinicians elicit and recasts 24 utterances per session.
| Study group | Role | What they receive |
|---|---|---|
| Grammar treatment including semantic support | Experimental | Children receiving grammatical treatment will also receive a simple explanation concerning the meaning of verbs used to elicit grammatical forms. Receives: Behavioral: Enhanced Conversational Recast treatment |
| Grammatical treatment excluding semantic support | Active comparator | Children receiving grammatical treatment will not receive any explanation concerning the meaning of verbs used to elicit grammatical forms. Receives: Behavioral: Enhanced Conversational Recast treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Use of Treated Grammatical Forms in Untreated Contexts
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects for the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Measured: Three days over the course of the final week (week 5) of treatment
Change in the Use of Untreated Grammatical Forms in Untreated Contexts
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Measured: Three days over the course of the final week (week 5) of treatment
Retention of Trained Grammatical Forms
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Measured: 1 day, 1-2 months after the end of treatment
Retention of Untrained Grammatical Forms
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Measured: 1 day, 1-2 months from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start17 Jun 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Language Disorders in ChildrenStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid single subject/group design
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Plante, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250101
- Sponsor's protocol ID
- DLD-Tx2
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2024
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plante E, Ogilvie T, Vance R, Aguilar JM, Dailey NS, Meyers C, Lieser AM, Burton R. Variability in the language input to children enhances learning in a treatment context. Am J Speech Lang Pathol. 2014 Nov;23(4):530-45. doi: 10.1044/2014_AJSLP-13-0038.
PubMed 24700145Meyers-Denman CN, Plante E. Dose Schedule and Enhanced Conversational Recast Treatment for Children With Specific Language Impairment. Lang Speech Hear Serv Sch. 2016 Oct 1;47(4):334-346. doi: 10.1044/2016_LSHSS-15-0064.
PubMed 27701629Plante E, Mettler HM, Tucci A, Vance R. Maximizing Treatment Efficiency in Developmental Language Disorder: Positive Effects in Half the Time. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1233-1247. doi: 10.1044/2019_AJSLP-18-0285. Epub 2019 Jul 25.
PubMed 31343897Sweeney L, Plante E, Mettler HM, Hall J, Vance R. Less Versus More: The Effect of Recast Length in Treatment of Grammatical Errors. Lang Speech Hear Serv Sch. 2024 Jan 11;55(1):152-165. doi: 10.1044/2023_LSHSS-23-00049. Epub 2023 Dec 1.
PubMed 38039976
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 5: Effects of Semantic Support
- ClinicalTrials.gov ID
- NCT06250101
- Acronym / sponsor ID
- DLD-Tx2
- Conditions
- Language Disorders in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll children between the ages of 4 and 6 years of age who exhibit significant difficulty developing language skills without any other handicapping conditions. Children will receive standardized language, hearing, and cognitive testing to confirm a diagnosis of developmental language disorder. Children will be enrolled in a half-day summer camp program for six weeks during which they will receive treatment designed to improve their language skills. Children will be seen again approximately six weeks after the end of treatment to determine how much learning they have retained.
Detailed description
Children between 4 years, 0 months and 6 years 11 months are eligible. A diagnosis of developmental language disorders will be confirmed as normal nonverbal cognitive function, passing a pure-tone audiometric screening, and a test score consistent with developmental language disorder on a standardized language test, and parent report of no other diagnosed handicapping condition. Speech skills and vocabulary skills will be described via standardized testing.
Children enrolled in treatment are seen for up to 28 consecutive weekdays. The study starts with three days of baseline assessment of morpheme use for potential treatment targets. Two are selected for study, with one treated and one tracked over the course of treatment. Treatment is embedded in child-friendly activities like games, book reading, and craft activities. Children are prompted to use the treated morpheme in conversation. Immediately following this attempt, the treating clinician repeats the child's utterance, correcting any ungrammatical forms. Half of the children will also receive explanations of what the key words in sentences mean (e.g., to twirl means to turn around fast). Generalization to untreated contexts is assessed 2-3 times weekly. Retention of learning is measured about six weeks after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Hybrid single subject/group design
| Arm | Type | Receives |
|---|---|---|
| Grammar treatment including semantic support | Experimental | Behavioral: Enhanced Conversational Recast treatmentChildren receiving grammatical treatment will also receive a simple explanation concerning the meaning of verbs used to elicit grammatical forms. |
| Grammatical treatment excluding semantic support | Active comparator | Behavioral: Enhanced Conversational Recast treatmentChildren receiving grammatical treatment will not receive any explanation concerning the meaning of verbs used to elicit grammatical forms. |
Who may qualify
- Ages
- 48 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning
Key exclusion criteria (1 listed)
- hearing loss Intellectual disability Other handicapping conditions
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 |
|---|---|---|
| Enhanced Conversational Recast treatmentIn the context of child-friendly activities, the clinician prompts the child to attempt to use the grammatical form targeted in the treatment. The clinician immediately restates the child's attempt (i.e., the recast), correcting any ungrammatical elements. Clinicians elicit and recasts 24 utterances per session. | Behavioural | Grammar treatment including semantic support, Grammatical treatment excluding semantic support |
Primary outcome
Change in the Use of Treated Grammatical Forms in Untreated Contexts
Time frame: Three days over the course of the final week (week 5) of treatment
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects for the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Change in the Use of Untreated Grammatical Forms in Untreated Contexts
Time frame: Three days over the course of the final week (week 5) of treatment
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'generalization probe'. Because children begin treatment with different levels of pretreatment use, measures like percent use at the end of treatment do not accurately reflect treatment effects. Instead, for each child, data from three generalization probes obtained over a week at the end of treatment are averaged. This average, minus the average of three consecutive pre-treatment probe sessions, divided by the standard deviation of the three end-treatment probes constitutes a Generalization d. This reflects the amount of change each individual child showed from their pre-treatment baseline, in units of standard deviation. The Generalization d serves as the dependent measure for group statistical analysis.
Retention of Trained Grammatical Forms
Time frame: 1 day, 1-2 months after the end of treatment
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Retention of Untrained Grammatical Forms
Time frame: 1 day, 1-2 months from the end of treatment
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done in a conversational interaction between the clinician and child during play or stories using toys and is referred to as a 'retention probe' when done, as here, after a period of no treatment. The dependent measure is the number correct out of 10 opportunities for use of the grammatical form.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24700145Plante E, Ogilvie T, Vance R, Aguilar JM, Dailey NS, Meyers C, Lieser AM, Burton R. Variability in the language input to children enhances learning in a treatment context. Am J Speech Lang Pathol. 2014 Nov;23(4):530-45. doi: 10.1044/2014_AJSLP-13-0038.
- Background: PubMed 27701629Meyers-Denman CN, Plante E. Dose Schedule and Enhanced Conversational Recast Treatment for Children With Specific Language Impairment. Lang Speech Hear Serv Sch. 2016 Oct 1;47(4):334-346. doi: 10.1044/2016_LSHSS-15-0064.
- Background: PubMed 31343897Plante E, Mettler HM, Tucci A, Vance R. Maximizing Treatment Efficiency in Developmental Language Disorder: Positive Effects in Half the Time. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1233-1247. doi: 10.1044/2019_AJSLP-18-0285. Epub 2019 Jul 25.
- Background: PubMed 38039976Sweeney L, Plante E, Mettler HM, Hall J, Vance R. Less Versus More: The Effect of Recast Length in Treatment of Grammatical Errors. Lang Speech Hear Serv Sch. 2024 Jan 11;55(1):152-165. doi: 10.1044/2023_LSHSS-23-00049. Epub 2023 Dec 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Conversational Recast treatment in people with Language Disorders in Children, run by University of Arizona at 1 site 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 1 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 the Use of Treated Grammatical Forms in Untreated Contexts (time frame: Three days over the course of the final week (week 5) of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250101, which also lists 4 linked publications.
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 2 Apr 2026.