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Speech Therapy Frequency for Pediatric Speech and Language Disorders

N/A
Waitlist Available
Led By Virginia Van Epps, M.Ed.
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Completed 1 plan of care (POC) with a duration of 8 sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights

Study Summary

This trial will compare weekly vs. every-other-week speech therapy in kids 18m-16y to see if it impacts language & articulation scores. Kids will get 8 sessions & results will be compared.

Who is the study for?
This trial is for children aged 18 months to 16 years who need speech therapy and have completed one plan of care. They must attend at least 80% of their sessions, be recommended for individual treatment, and have a diagnosis related to language or articulation disorders. It's not for those unable to complete certain standardized tests or seeking therapy for voice, feeding, fluency, cognition issues.Check my eligibility
What is being tested?
The study compares the effectiveness of weekly versus every-other-week speech therapy sessions with home programming over eight sessions in outpatient settings. The focus is on whether session frequency affects language and articulation test scores in pediatric patients.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like speech therapy, traditional side effects associated with medications are not expected. However, there may be differences in progress or stress levels due to varying frequencies of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a communication disorder.
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I have completed an 8-session treatment plan.
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I am between 18 months and 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Articulation and intelligibility
Change in Expressive vocabulary skills
Change in Receptive and expressive early language skills
+1 more
Secondary outcome measures
Home Exercise Plan (HEP) provision

Side effects data

From 2015 Phase 2 trial • 10 Patients • NCT02514044
90%
Non-significant skin redness and tingling
20%
Mild Headache
10%
Mild Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo+tDCS+Speech Therapy
D-AMP+tDCS+Speech Therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Weekly therapy with home programmingExperimental Treatment1 Intervention
Receipt of speech therapy care (every week) for 8.0 sessions
Group II: Every-other-week therapy with home programmingActive Control1 Intervention
Receipt of standard speech therapy care (every-other-week) for 8.0 sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Speech Therapy
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,414 Total Patients Enrolled
Morgan Vallero, MSStudy DirectorConnecticut Children's Medical Center
Jodi Urzua, MSStudy DirectorConnecticut Children's Medical Center

Media Library

Speech Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05900180 — N/A
Pediatrics Research Study Groups: Weekly therapy with home programming, Every-other-week therapy with home programming
Pediatrics Clinical Trial 2023: Speech Therapy Highlights & Side Effects. Trial Name: NCT05900180 — N/A
Speech Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900180 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cap for this study 70 years or less?

"Participants that meet the age criteria of being between 18 months and 16 years can enrol in this trial."

Answered by AI

Is it permissible for me to take part in this experiment?

"Prospective patients must demonstrate a history of speech therapy and be between 18 months and 16 years old to qualify for this trial. 100 participants will eventually join the study."

Answered by AI

Is this experiment presently open to recruitment?

"According to the data available on clinicaltrials.gov, this medical trial is actively recruiting participants. This study was originally posted in January 1st 2023 and its information has been updated as recently as June 7th 2023."

Answered by AI

How many people have volunteered to participate in this clinical research?

"Affirmative. The clinicaltrial.gov website states that this research initiative, which was first published on January 1st 2023, is actively recruiting patients. Approximately 100 individuals need to be sourced from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pediatric Speech Therapy Session Frequency and Speech Outcomes
2023. "Pediatric Speech Therapy Session Frequency and Speech Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900180.
~35 spots leftby Dec 2024
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