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AAC Language Intervention for Speech and Language Disorders

Phase 2
Waitlist Available
Research Sponsored by University of Central Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare the effectiveness of AAC Generative Language Intervention to AAC Standard of Care on sentence production in preschoolers.

Who is the study for?
This trial is for preschoolers with speech disorders, including those with Down Syndrome, who primarily speak English. They must be able to express at least 25 words in any form and accurately select picture symbols on an AAC iPad app over half the time. Children with autism or social communication disorder are not eligible.Check my eligibility
What is being tested?
The study compares two methods: AAC Generative Language Intervention and Standard of Care using existing AAC iPad apps. It aims to see which approach better helps these children produce sentences.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional physical side effects are not applicable. However, there may be varying levels of engagement or frustration during the learning process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Aided AAC Utterance Length

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment2 Interventions
AAC Generative Language Intervention
Group II: Business as UsualActive Control1 Intervention
Standard of Care / Business as Usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AAC Generative Language Intervention
2018
Completed Phase 2
~70
Standard of Care / Business as Usual
2018
Completed Phase 2
~1780

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,235 Total Patients Enrolled
University of Central FloridaLead Sponsor
78 Previous Clinical Trials
1,097,406 Total Patients Enrolled
University of New MexicoOTHER
372 Previous Clinical Trials
3,528,719 Total Patients Enrolled

Media Library

AAC Generative Language Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03538925 — Phase 2
Speech and Language Disorder Research Study Groups: Business as Usual, Treatment Group
Speech and Language Disorder Clinical Trial 2023: AAC Generative Language Intervention Highlights & Side Effects. Trial Name: NCT03538925 — Phase 2
AAC Generative Language Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03538925 — Phase 2

Frequently Asked Questions

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

Could I potentially be eligible to join this clinical trial?

"This clinical trial seeks 120 candidates who possess articulate speech and are between 3 to 4 years old."

Answered by AI

Is there a recruitment period for this research endeavor?

"According to data hosted on clinicaltrials.gov, this experiment is open for recruitment and has been listed since May 11th 2018 with the most recent amendment made 3 days ago."

Answered by AI

To what degree could AAC Generative Language Intervention be hazardous to individuals?

"Our team has determined that AAC Generative Language Intervention is likely safe, awarding it a score of 2. This Phase 2 trial provides some evidence for its safety but there are still no conclusive results regarding efficacy."

Answered by AI

Is this investigation open to elderly participants aged 75 and above?

"This research initiative is targeting young individuals aged three to four years old."

Answered by AI

How many participants are engaging in the experiment?

"Affirmative. Clinicaltrials.gov states this clinical trial is currently welcoming participants, and was initially shared on May 11th 2018 with an additional update occurring on May 13 2021. The study requires 120 patients to be recruited from two separate medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
< 18
What site did they apply to?
FAAST Center at the University of Central Florida
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. FAAST Center at the University of Central Florida: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Building Sentences With Preschoolers Who Use AAC
2018. "Building Sentences With Preschoolers Who Use AAC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03538925.
~10 spots leftby Apr 2025
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