Pediatric Speech Therapy Session Frequency and Speech Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Language Disorders in Children; Pediatric; Speech Therapy; Articulation Disorders in Children; Communication Disorder, Childhood
• Intervention / Treatment: Behavioral: Speech Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Van Epps, M.Ed.; Phone Number: (860) 837-5903; Email: Vvanepps@connecticutchildrens.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06010
      • ConnecticutCMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Every-other-week therapy with home programming; Receipt of standard speech therapy care (every-other-week) for 8.0 sessions	Behavioral: Speech Therapy; Delivery of speech therapy services
Experimental: Weekly therapy with home programming; Receipt of speech therapy care (every week) for 8.0 sessions	Behavioral: Speech Therapy; Delivery of speech therapy services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Exercise Plan (HEP) provision	Parent-reported compliance with home therapy programming	up to 4 months

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: Virginia Van Epps, M.Ed., Connecticut Children's Medical Center; Study Director: Mary Dortenzio, MS, Connecticut Children's Medical Center; Study Director: Jodi Urzua, MS, Connecticut Children's Medical Center; Study Director: Emma Mandillo, MA, Connecticut Children's Medical Center; Study Director: Morgan Vallero, MS, Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Speech Disorders; Language Disorders; Articulation Disorders; Communication Disorders
• Other Study ID Numbers: 22-160

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