Pediatric Speech Therapy Session Frequency and Speech Outcomes

April 28, 2026 updated by: Connecticut Children's Medical Center
Examination of frequency of therapy and effect on clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

39

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

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center

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

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
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.
Baseline, immediately after treatment (up to 4 months)
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.
Baseline, immediately after treatment (up to 4 months)
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.
Baseline, immediately after treatment (up to 4 months)
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.
Baseline, immediately after treatment (up to 4 months)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Mendillo, MA, Connecticut Children's Medical Center
  • Study Director: Morgan Daur-Schierholz, MS, Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

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)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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