Back to resultsPediatric Speech Therapy Session Frequency and Speech Outcomes
Primary Purpose
Speech Therapy, Language Disorders in Children, Articulation Disorders in Children
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speech Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Speech Therapy
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
Sites / Locations
- ConnecticutCMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Every-other-week therapy with home programming
Weekly therapy with home programming
Arm Description
Receipt of standard speech therapy care (every-other-week) for 8.0 sessions
Receipt of speech therapy care (every week) for 8.0 sessions
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Home Exercise Plan (HEP) provision
Parent-reported compliance with home therapy programming
Full Information
NCT ID
NCT05900180
First Posted
April 20, 2023
Last Updated
July 3, 2023
Sponsor
Connecticut Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05900180
Brief Title
Pediatric Speech Therapy Session Frequency and Speech Outcomes
Official Title
Pediatric Speech Therapy Session Frequency and Speech Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Connecticut Children's Medical Center
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Therapy, Language Disorders in Children, Articulation Disorders in Children, Communication Disorder, Childhood, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Every-other-week therapy with home programming
Arm Type
Active Comparator
Arm Description
Receipt of standard speech therapy care (every-other-week) for 8.0 sessions
Arm Title
Weekly therapy with home programming
Arm Type
Experimental
Arm Description
Receipt of speech therapy care (every week) for 8.0 sessions
Intervention Type
Behavioral
Intervention Name(s)
Speech Therapy
Intervention Description
Delivery of speech therapy services
Primary Outcome Measure Information:
Title
Change in Articulation and intelligibility
Description
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.
Time Frame
Baseline, immediately after treatment (up to 4 months)
Title
Change in Receptive vocabulary skills
Description
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.
Time Frame
Baseline, immediately after treatment (up to 4 months)
Title
Change in Expressive vocabulary skills
Description
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.
Time Frame
Baseline, immediately after treatment (up to 4 months)
Title
Change in Receptive and expressive early language skills
Description
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.
Time Frame
Baseline, immediately after treatment (up to 4 months)
Secondary Outcome Measure Information:
Title
Home Exercise Plan (HEP) provision
Description
Parent-reported compliance with home therapy programming
Time Frame
up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Van Epps, M.Ed.
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Dortenzio, MS
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jodi Urzua, MS
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emma Mandillo, MA
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Morgan Vallero, MS
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
ConnecticutCMC
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pediatric Speech Therapy Session Frequency and Speech Outcomes
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