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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • The University of Arizona

    Tucson, Arizona, 85721

Other trials in United States

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.

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 groups in NCT06250101
Study groupRoleWhat they receive
Grammar treatment including semantic supportExperimentalChildren 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 supportActive comparatorChildren 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted8 Feb 2024
  2. Study start17 Jun 2024
  3. Primary completion30 Aug 2025
  4. Study completion30 Aug 2025

Resources

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)
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
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 24700145
  • Meyers-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 27701629
  • Plante 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 31343897
  • Sweeney 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

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.

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