Clinical trial NCT05900180: Pediatric Speech Therapy Session Frequency and Speech Outcomes
Official title: Pediatric Speech Therapy Session Frequency and Speech Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Speech Therapy
Language Disorders in Children
Articulation Disorders in Children
Communication Disorder, Childhood
Pediatric
Mode of Therapy
Frequency of Therapy
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Articulation and intelligibility
timeFrame: Baseline, immediately after treatment (up to 4 months)
measure: Change in Receptive vocabulary skills
timeFrame: Baseline, immediately after treatment (up to 4 months)
measure: Change in Expressive vocabulary skills
timeFrame: Baseline, immediately after treatment (up to 4 months)
measure: Change in Receptive and expressive early language skills
timeFrame: Baseline, immediately after treatment (up to 4 months)
Secondary outcomes:
measure: Home Exercise Plan (HEP) provision
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Virginia Van Epps, M.Ed.
role: PRINCIPAL_INVESTIGATOR
affiliation: Connecticut Children's Medical Center
name: Mary Dortenzio, MS
role: STUDY_DIRECTOR
affiliation: Connecticut Children's Medical Center
name: Jodi Urzua, MS
role: STUDY_DIRECTOR
affiliation: Connecticut Children's Medical Center
name: Emma Mendillo, MA
role: STUDY_DIRECTOR
affiliation: Connecticut Children's Medical Center
name: Morgan Daur-Schierholz, MS
role: STUDY_DIRECTOR
References: