NCT05953077

Brief 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. 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 start with 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

August 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

June 9, 2023

Last Update Submit

August 22, 2024

Conditions

Keywords

treatment

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. Change is assessed throughout the treatment period.

    3 days per week over 6 weeks

  • Change in the use of grammatical forms in untreated contexts

    Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions. Change is assessed throughout the treatment period.

    3 days per week over 6 weeks

  • Retention of trained grammatical forms

    Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.

    One session, approximately 6 weeks after treatment concludes.

  • Retention of untrained grammatical forms

    Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.

    One session, approximately 6 weeks after treatment concludes.

Secondary Outcomes (1)

  • Change in spontaneous use

    5 sessions a week over 6 weeks.

Study Arms (2)

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.

Behavioral: Conversational recasting

Hard first

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 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.

Behavioral: Conversational recasting

Interventions

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.

Easy firstHard first

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Native English speaking
  • Passed a pure-tone hearing screening
  • years of age
  • SPELT-P2 (language) test score of \< 87
  • K-ABC-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

You may not qualify if:

  • Parent report of other handicapping conditions
  • Clinical signs of other disorders
  • Enrolled in outside treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Plante, PhD

CONTACT

Rebecca Vance, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Parents are masked concerning children's specific language goals and treatment conditions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: quasi-experimental design with two active treatment groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

July 19, 2023

Study Start

February 1, 2022

Primary Completion

October 30, 2024

Study Completion

April 30, 2025

Last Updated

August 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
Data is available for sharing after initial publication and for a minimum of 5 years after publication.
Access Criteria
Secondary use must be consistent with the intent of the original consent document.

Locations