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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05900180
Other study ID # 22-160
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 30, 2024

Study information

Verified date July 2023
Source Connecticut Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Months to 16 Years
Eligibility Inclusion Criteria: - Medical order for speech therapy - Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy) - Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841) - Patient recommended for individual (i.e. not group) treatment - 18 months to 16 years of age - Completed 1 plan of care (POC) with a duration of 8 sessions - Attended at least 80% of scheduled visits during their plan of care period (still completing 8 sessions of therapy, may have extended time to completion). - Services for a full 8-session plan of care. Exclusion Criteria: - - Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition - Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4) - Patients in group speech therapy - Patients younger than 18 months or older than 16 years of age - Not willing to complete a full POC (8 sessions) - Unable/unwilling to attend 80% of scheduled visits

Study Design


Intervention

Behavioral:
Speech Therapy
Delivery of speech therapy services

Locations

Country Name City State
United States ConnecticutCMC Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Articulation and intelligibility Scores on the following standardized measures: Goldman Fristoe Test of Articulation- Third Edition (GFTA-3) ; Average Standard Score range is from 86-114; an increase in standard score indicates improvement in intelligibility. Baseline, immediately after treatment (up to 4 months)
Primary Change in Receptive vocabulary skills Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition (ROVPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary. Baseline, immediately after treatment (up to 4 months)
Primary Change in Expressive vocabulary skills Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition (EOWPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary. Baseline, immediately after treatment (up to 4 months)
Primary Change in Receptive and expressive early language skills Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition (REEL-4); Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score. Baseline, immediately after treatment (up to 4 months)
Secondary Home Exercise Plan (HEP) provision Parent-reported compliance with home therapy programming up to 4 months
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