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Clinical Trials/NCT05900180
NCT05900180
Active, Not Recruiting
N/A

Pediatric Speech Therapy Session Frequency and Speech Outcomes

Connecticut Children's Medical Center1 site in 1 country39 target enrollmentJanuary 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Speech Therapy
Sponsor
Connecticut Children's Medical Center
Enrollment
39
Locations
1
Primary Endpoint
Change in Receptive vocabulary skills
Status
Active, Not Recruiting
Last Updated
12 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 30, 2027
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Receptive vocabulary skills

Time Frame: Baseline, immediately after treatment (up to 4 months)

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.

Change in Receptive and expressive early language skills

Time Frame: Baseline, immediately after treatment (up to 4 months)

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.

Change in Articulation and intelligibility

Time Frame: Baseline, immediately after treatment (up to 4 months)

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.

Change in Expressive vocabulary skills

Time Frame: Baseline, immediately after treatment (up to 4 months)

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.

Secondary Outcomes

  • Home Exercise Plan (HEP) provision(up to 4 months)

Study Sites (1)

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