Developmental Language DisorderNCT05953077
The Effect of Prior Learning on Treatment of Morpheme Errors
A study testing Conversational recasting in people with Developmental Language Disorder, run by University of Arizona at 1 site in United States.
Trial summary
This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- Conversational recasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Apr 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Native English speaking
- Passed a pure-tone hearing screening
- 4-6 years of age
- Structured Photographic Expressive Language Test-Preschool 2 (language) test score of < 87
- Kaufman Assessment Battery for Children-II Nonverbal Scale (cognition) test score of >75
- Sufficient morpheme errors to serve as treatment and control targets
- Articulations skills sufficient to judge use of language targets
- Able to attend treatment daily
Who cannot join
- Parent report of other handicapping conditions
- Clinical signs of other disorders
- Enrolled in outside treatment
Trial locations and contacts
1 site in 1 country.
About this study
This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. Children will receive one-on-one behavioral treatment over a six week period. Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. The other half will only be treated for a grammatical form they rarely use. The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.
Read the detailed description
This is a early-efficacy treatment study designed to determine whether learning of a very low-use grammatical form can be made more efficient by beginning treatment with a form that is partially, but not fully acquired. Children qualify for the study by showing evidence of impaired language skills in the absence of intellectual disability, hearing loss, or other parent-reported handicapping conditions that could affect language skills. Preschool children with a developmental language disorder are provided 24 teaching episodes of Enhanced Conversational Recast daily for up to 25 days. Treatment gains are measured as change from baseline use of probes designed to measure generalization to untreated grammatical forms.
- Conditions
- Developmental Language Disorder
- Being tested
- Conversational recasting
- Keywords
- treatment
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational recastingBehavioural
The treatment procedure uses 24 treatment doses embedded into child-friendly activities (crafts, book reading, play). Each each consists of a clinician eliciting use of a targeted grammatical form, a child's attempt (correct or incorrect) to use that form, and an immediate clinician repetition of the child's attempt (a recast), correcting any ungrammatical elements as needed. Clinicians must also attempt to gain the child's attention before providing the recast. Treatment sessions are approximately 30 minutes in duration.
| Study group | Role | What they receive |
|---|---|---|
| Easy first | Experimental | Children are treated for an emergent grammatical form that is used correctly at least 60% during three pre-treatment probe sessions. This form is treated until children generalize it's use an average of 90% or more across 3 probe sessions. Their treatment target is then switched to a grammatical form that is used less than 30% correct across 3 pre-treatment probe sessions. Receives: Behavioral: Conversational recasting |
| Hard Only | Active comparator | Children are treated for a grammatical form that is used accurately less than 30% of the time during 3 pre-treatment probe sessions. This form is treated for the entire treatment period Receives: Behavioral: Conversational recasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Percent Correct 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 on each of three days at the end of the treatment period. The percent use calculated as (#correct/10)*100 is calculated over three days at the end of treatment, and these values are averaged for each child. Note that only performance on the hard target is considered in the analysis, even for children previously treated on an easier target. This tests the hypothesis that prior treatment of an easy target speeds learning of a hard target, compared to starting treatment with a hard target. The easy target is not compared to the hard target because, by design, this target to a high level of use, whereas learning levels for the hard target are free to vary.
Measured: Three sessions conducted on three separate days during the sixth week 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 and the percent correct use is calculated as (#correct/10)*100.
Measured: One session, approximately 6 weeks after treatment concludes.
Secondary outcomes (1)
Overall Treatment Efficacy
This analysis tests the hypothesis that the treatment in general (collapsed across treatment arms) leads to gains in the use of treated grammatical forms compared with no treatment of grammatical forms. Measures reporting single-participant treatment effect size are typically reported with a Unit of Measure in treatment effect size d. Single-subject treatment effect size d metric reflects gains in morpheme use from baseline levels to the end of treatment, for each individual child. This is calculated for each of the Target and Control morphemes as "Generalization d = ((end treatment percent correct mean - pretreatment percent correct mean)/ (end treatment standard deviation)). Note that the percent correct means are based on the average percent correct use for three sessions pretreatment and during the 6th week of treatment.
Measured: Three sessions conducted on three separate days during the sixth week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Feb 2022
- Primary completion30 Oct 2024
- Study completion30 Apr 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.
- Other trials for Developmental Language DisorderStudies 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
- quasi-experimental design with two active treatment groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Plante, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953077
- Sponsor's protocol ID
- DLD-Tx1
- Status last verified
- Jan 2024
- First submitted
- 9 Jun 2023
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, including clinical test scores and outcome measures, are shared in publications and presentations. Other study data is provided by request from the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prior Learning on Treatment of Morpheme Errors
- ClinicalTrials.gov ID
- NCT05953077
- Acronym / sponsor ID
- DLD-Tx1
- Conditions
- Developmental Language Disorder
- Keywords
- treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. Children will receive one-on-one behavioral treatment over a six week period. Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. The other half will only be treated for a grammatical form they rarely use. The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.
Detailed description
This is a early-efficacy treatment study designed to determine whether learning of a very low-use grammatical form can be made more efficient by beginning treatment with a form that is partially, but not fully acquired. Children qualify for the study by showing evidence of impaired language skills in the absence of intellectual disability, hearing loss, or other parent-reported handicapping conditions that could affect language skills. Preschool children with a developmental language disorder are provided 24 teaching episodes of Enhanced Conversational Recast daily for up to 25 days. Treatment gains are measured as change from baseline use of probes designed to measure generalization to untreated grammatical forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- quasi-experimental design with two active treatment groups
| Arm | Type | Receives |
|---|---|---|
| Easy first | Experimental | Behavioral: Conversational recastingChildren are treated for an emergent grammatical form that is used correctly at least 60% during three pre-treatment probe sessions. This form is treated until children generalize it's use an average of 90% or more across 3 probe sessions. Their treatment target is then switched to a grammatical form that is used less than 30% correct across 3 pre-treatment probe sessions. |
| Hard Only | Active comparator | Behavioral: Conversational recastingChildren are treated for a grammatical form that is used accurately less than 30% of the time during 3 pre-treatment probe sessions. This form is treated for the entire treatment period |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Native English speaking
- Passed a pure-tone hearing screening
- 4-6 years of age
- Structured Photographic Expressive Language Test-Preschool 2 (language) test score of < 87
- Kaufman Assessment Battery for Children-II Nonverbal Scale (cognition) test score of >75
Key exclusion criteria (3 listed)
- Parent report of other handicapping conditions
- Clinical signs of other disorders
- Enrolled in outside treatment
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 |
|---|---|---|
| Conversational recastingThe treatment procedure uses 24 treatment doses embedded into child-friendly activities (crafts, book reading, play). Each each consists of a clinician eliciting use of a targeted grammatical form, a child's attempt (correct or incorrect) to use that form, and an immediate clinician repetition of the child's attempt (a recast), correcting any ungrammatical elements as needed. Clinicians must also attempt to gain the child's attention before providing the recast. Treatment sessions are approximately 30 minutes in duration. | Behavioural | Easy first, Hard Only |
Primary outcome
The Average Percent Correct Use of Treated Grammatical Forms in Untreated Contexts
Time frame: Three sessions conducted on three separate days during the sixth week of treatment.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. This is done on each of three days at the end of the treatment period. The percent use calculated as (#correct/10)*100 is calculated over three days at the end of treatment, and these values are averaged for each child. Note that only performance on the hard target is considered in the analysis, even for children previously treated on an easier target. This tests the hypothesis that prior treatment of an easy target speeds learning of a hard target, compared to starting treatment with a hard target. The easy target is not compared to the hard target because, by design, this target to a high level of use, whereas learning levels for the hard target are free to vary.
Retention of Trained Grammatical Forms
Time frame: One session, approximately 6 weeks after treatment concludes.
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions and the percent correct use is calculated as (#correct/10)*100.
1 secondary outcome
Overall Treatment Efficacy
Time frame: Three sessions conducted on three separate days during the sixth week of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data, including clinical test scores and outcome measures, are shared in publications and presentations. Other study data is provided by request from the study PI.
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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.
Elena Plante, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational recasting in people with Developmental Language Disorder, 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 8 inclusion and 3 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 5 Oct 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 5 Oct 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?
The Average Percent Correct Use of Treated Grammatical Forms in Untreated Contexts (time frame: Three sessions conducted on three separate days during the sixth week of treatment.). 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 5 Oct 2026.