Pediatric Speech Therapy Session Frequency and Speech Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Pediatric Speech Therapy Session Frequency and Speech Outcomes

Conditions
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Speech Therapy, Language Disorders in Children, Articulation Disorders in Children, Communication Disorder, Childhood, Pediatric

Intervention / Treatment
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* Behavioral: Speech Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |