Pediatric Speech Therapy Session Frequency and Speech Outcomes

Sponsor
Connecticut Children's Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05900180
Collaborator
(none)
100
1
2
24
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Speech Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pediatric Speech Therapy Session Frequency and Speech Outcomes
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Articulation and intelligibility [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 [Baseline, immediately after treatment (up to 4 months)]

    Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition, Expressive One Word Picture Vocabulary Test- Fourth Edition; Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary. ROVPVT-4

  3. Change in Expressive vocabulary skills [Baseline, immediately after treatment (up to 4 months)]

    Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition; Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary. EOWPVT-4

  4. Change in Receptive and expressive early language skills [Baseline, immediately after treatment (up to 4 months)]

    Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition; Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score.

Secondary Outcome Measures

  1. Home Exercise Plan (HEP) provision [up to 4 months]

    Parent-reported compliance with home therapy programming

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ConnecticutCMC Hartford Connecticut United States 06010

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT05900180
Other Study ID Numbers:
  • 22-160
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023