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The Effect of Prior Learning on Treatment of Morpheme Errors

Primary Purpose

Developmental Language Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conversational recasting
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Language Disorder focused on measuring treatment

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Native English speaking Passed a pure-tone hearing screening 4-6 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 Exclusion Criteria: Parent report of other handicapping conditions Clinical signs of other disorders Enrolled in outside treatment

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Easy first

Hard first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in spontaneous use
The number of unprompted use of the trained grammatical form that occurs during treatment sessions. Change is measured relative to baseline.

Full Information

First Posted
June 9, 2023
Last Updated
September 25, 2023
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT05953077
Brief Title
The Effect of Prior Learning on Treatment of Morpheme Errors
Official Title
The Effect of Prior Learning on Treatment of Morpheme Errors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder
Keywords
treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
quasi-experimental design with two active treatment groups
Masking
Care Provider
Masking Description
Parents are masked concerning children's specific language goals and treatment conditions.
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Easy first
Arm Type
Experimental
Arm Description
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.
Arm Title
Hard first
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conversational recasting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the use of treated grammatical forms in untreated contexts
Description
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.
Time Frame
3 days per week over 6 weeks
Title
Change in the use of grammatical forms in untreated contexts
Description
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.
Time Frame
3 days per week over 6 weeks
Title
Retention of trained grammatical forms
Description
Clinicians elicit ten uses of the trained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
Time Frame
One session, approximately 6 weeks after treatment concludes.
Title
Retention of untrained grammatical forms
Description
Clinicians elicit ten uses of the untrained grammatical form using toys, activities, and vocabulary with-held from treatment sessions.
Time Frame
One session, approximately 6 weeks after treatment concludes.
Secondary Outcome Measure Information:
Title
Change in spontaneous use
Description
The number of unprompted use of the trained grammatical form that occurs during treatment sessions. Change is measured relative to baseline.
Time Frame
5 sessions a week over 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Native English speaking Passed a pure-tone hearing screening 4-6 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 Exclusion Criteria: Parent report of other handicapping conditions Clinical signs of other disorders Enrolled in outside treatment
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data is available for sharing after initial publication and for a minimum of 5 years after publication.
IPD Sharing Access Criteria
Secondary use must be consistent with the intent of the original consent document.

Learn more about this trial

The Effect of Prior Learning on Treatment of Morpheme Errors

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