- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663972
Age-related Correlates of Treatment for Late-acquired Sounds (ARC)
June 16, 2020 updated by: Breanna Irene Krueger, University of Wyoming
Age-related Correlates of Treatment Efficacy and Efficiency for Late-acquired Sounds
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds.
The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds.
However, these sounds are often treated later in a child's life because they are not expected to be fully acquired until quite late--age 7-8 for some sounds.
This practice places treatment in a time of the child's development in which they struggle to learn new sounds.The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes, and to examine treatment efficacy and efficiency for two methods of treatment.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wyoming
-
Laramie, Wyoming, United States, 82071
- University of Wyoming
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusionary Criteria:
- Normal Hearing
- Typical Receptive Language
- Speech Sound Disorder
- No motor speech impairment
- Typical non-verbal intelligence
- Produces at least one late-acquired sound with <7% accuracy
- Monolingual English-speaking
- Typical in terms of motoric and neurological development
Exclusionary Criteria:
- Neurological disorder
- Hearing loss
- Nonverbal IQ < 16th percentile
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Motoric Arm
Children will participate in an intervention based on traditional articulation approaches to speech therapy.
|
children receive instruction in producing new sounds at the isolation, syllable and word level.
|
|
Active Comparator: Phonologic Arm
Children will receive intervention that targets the conceptual representation of sounds.
|
children receive instruction in producing new sounds at the word level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Efficacy: Number of correct productions of treated speech sounds in treatment words
Time Frame: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
|
Accurate Production of treatment sound at baseline and at posttest
|
baseline until accuracy criterion is met; up to 18 weeks after final baseline session
|
|
Treatment Efficiency: Number of sessions required to meet accuracy criteria
Time Frame: baseline until accuracy criterion is met; up to 18 weeks after final baseline session
|
Number of treatment sessions required to meet accuracy criteria (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
|
baseline until accuracy criterion is met; up to 18 weeks after final baseline session
|
|
Session Length: Mean duration of sessions in minutes
Time Frame: First treatment session until final treatment session. Final treatment session occurs when accuracy of treatment sound is met (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
|
Start and end time of session is recorded on scoresheet, then number of minutes for each session for each participant is found and the mean across all sessions is calculated.
|
First treatment session until final treatment session. Final treatment session occurs when accuracy of treatment sound is met (90% accuracy across three consecutive sessions or a maximum of 35 treatment sessions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of production of untreated sounds measured on pretest and posttest probes
Time Frame: baseline and at posttest up to 18 weeks after final baseline session
|
Some children may generalize their skills learned through treatment to sounds that were not treated in the trial.
|
baseline and at posttest up to 18 weeks after final baseline session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Breanna I. Krueger, PhD, University of Wyoming
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2018
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
August 31, 2018
First Submitted That Met QC Criteria
September 6, 2018
First Posted (Actual)
September 10, 2018
Study Record Updates
Last Update Posted (Actual)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180510BK01978
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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