Pediatric Clinical Trial
Official title:
Pediatric Speech Therapy Session Frequency and Speech Outcomes
Verified date | July 2023 |
Source | Connecticut Children's Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | ConnecticutCMC | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Home Exercise Plan (HEP) provision | Parent-reported compliance with home therapy programming | up to 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Completed |
NCT01981954 -
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
|
Phase 3 | |
Completed |
NCT02199626 -
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
|
Phase 4 | |
Recruiting |
NCT04679792 -
Postual Control in Pediatric Chiari I Malformation
|
||
Recruiting |
NCT06061159 -
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
|
Phase 4 | |
Active, not recruiting |
NCT05453968 -
Berotralstat Treatment in Children With Hereditary Angioedema
|
Phase 3 | |
Not yet recruiting |
NCT02182648 -
Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction
|
Phase 4 | |
Active, not recruiting |
NCT04176640 -
Quantifying Brain Injury on Computed Tomography in Hospitalized Children
|
||
Active, not recruiting |
NCT06146452 -
Micronutrient Status in Pediatric Palliative Care
|
||
Completed |
NCT04041180 -
Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
|
||
Not yet recruiting |
NCT06165003 -
Examination of Nurses' Use of Broselow Tape in Non-resuscitation Pediatric Emergency Department Practices
|
N/A | |
Recruiting |
NCT02286297 -
Pediatric Endotracheal Intubation During Resuscitation
|
N/A | |
Unknown status |
NCT00613184 -
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
|
N/A | |
Recruiting |
NCT00265772 -
Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis
|
Phase 4 | |
Completed |
NCT04106063 -
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children
|
||
Not yet recruiting |
NCT06376643 -
Augmented Reality to Support Cardiopulmonary Resuscitation
|
N/A | |
Not yet recruiting |
NCT05511233 -
ERAS Protocol in Newborns: CARES Study
|
N/A | |
Not yet recruiting |
NCT04127968 -
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
|
N/A | |
Active, not recruiting |
NCT04472286 -
Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors
|
||
Recruiting |
NCT05909878 -
Virtual Reality Distraction for Anxiety (VR-IMAGINE at HSJ)
|
N/A |