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Completed

NCT Number: NCT05900180

Pediatric Speech Therapy Session Frequency and Speech Outcomes

Examination of frequency of therapy and effect on clinical outcomes.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speech Therapy

Behavioral

Delivery of speech therapy services

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Home Exercise Plan (HEP) provision

    Time frame: up to 4 months

    Parent-reported compliance with home therapy programming

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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