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Training Grammar With Meaning

Study 5: Effects of Semantic Support

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06250101
Enrollment
24
Registered
2024-02-08
Start date
2024-06-17
Completion date
2025-08-30
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Disorders in Children

Brief 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. 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.

Interventions

BEHAVIORALEnhanced Conversational Recast treatment

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.

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Caregivers are not informed of their child's treatment target until after treatment concludes. The clinician measuring retention of learning has not treated the children

Intervention model description

Hybrid single subject/group design

Eligibility

Sex/Gender
ALL
Age
48 Months to 83 Months
Healthy volunteers
No

Inclusion criteria

Language scores consistent with a developmental language disorder nonverbal cognitive scores consistent with normal-range intellectual functioning

Exclusion criteria

hearing loss Intellectual disability Other handicapping conditions

Design outcomes

Primary

MeasureTime frameDescription
Change in the Use of Treated Grammatical Forms in Untreated ContextsThree days over the course of the final week (week 5) of treatmentClinicians 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 ContextsThree days over the course of the final week (week 5) of treatmentClinicians 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 Forms1 day, 1-2 months after the end of treatmentClinicians 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 Forms1 day, 1-2 months from the end of treatmentClinicians 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.

Countries

United States

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
24 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous4 years
STANDARD_DEVIATION 0.5
Average percent use of grammatical forms6 Average percent correct use over 3 days
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026