NCT06250101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 10, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

January 23, 2024

Results QC Date

December 5, 2025

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 day, 1-2 months from the end of treatment

Study Arms (2)

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.

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.

Behavioral: Enhanced Conversational Recast treatment

Interventions

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.

Grammar treatment including semantic supportGrammatical treatment excluding semantic support

Eligibility Criteria

Age48 Months - 83 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • hearing loss Intellectual disability Other handicapping conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (4)

  • 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.

    PMID: 24700145BACKGROUND
  • 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.

    PMID: 27701629BACKGROUND
  • 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.

    PMID: 31343897BACKGROUND
  • 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.

    PMID: 38039976BACKGROUND

Results Point of Contact

Title
Elena Plante, PhD
Organization
University of Arizona

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Hybrid single subject/group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 8, 2024

Study Start

June 17, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

April 2, 2026

Results First Posted

February 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations