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NCT03903120 · ClinicalTrials.gov registry record · Phase 1
ASSIST: Treatment for Childhood Apraxia of Speech
A Phase 1 study of Childhood Apraxia of Speech, sponsored by Temple University.
- Active
- Registry status
- Phase 1
- Development phase
- 420
- Enrollment target
- 1
- Study location
NCT03903120: Active Phase 1 study of Childhood Apraxia of Speech, sponsored by Temple University.
NCT03903120 is a Phase 1 study of Childhood Apraxia of Speech that is active but no longer recruiting, run by Temple University. The registered enrollment target is 420 participants, above the 57-participant average among 3 other Childhood Apraxia of Speech trials with a reported enrollment target (637% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03903120, a Phase 1 study of Childhood Apraxia of Speech, is active but no longer recruiting, sponsored by Temple University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 420 participants
- Enrollment target
- 1
- Study location
Study Summary
Childhood apraxia of speech (CAS) is a pediatric motor speech disorder that impairs the planning of movements needed for intelligible speech. Children with CAS often show little or slow progress in standard speech therapy. This research is a Phase 1 study that tests initial efficacy and optimal parameters of a theoretically based integral stimulation treatment called ASSIST (Apraxia of Speech Systematic Integral Stimulation Treatment). In three small randomized group design studies, children (N=20 per study) receive 16 hours of individual ASSIST. The three studies systematically investigate treatment intensity (2 vs. 4 weeks) and two critical aspects of target selection: complexity (simple vs. complex target) and lexicality (words vs. nonwords). Each study also systematically examines the effect of treatment on functional outcome measures, including parent ratings of intelligibility and communicative participation, and objective intelligibility measures obtained from unfamiliar listeners.
Primary Outcome
Change in Perceptual accuracy of treated items (in percent), judged by 3 blinded listeners and averaged across the 3 listeners to obtain a single percent accuracy score. Listeners score each item as a 2 \[correct\], 1 \[minor error\], or 0 \[major error or multiple errors\]; scores are averaged across listeners and divided by 2 and multiplied by 100 to create a percentage. Change scores are calculated as defined by ClinicalTrials.gov.
Conditions Studied
Interventions
- BEHAVIORAL ASSIST
Study Locations (1)
Pennsylvania
- Temple University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2019-04-18 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
What the registry record for NCT03903120 still lists
NCT03903120 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 57-participant average among 3 other Childhood Apraxia of Speech trials with a reported enrollment target (637% higher).
The record links to 1 condition, with Childhood Apraxia of Speech appearing as the primary indexed condition, and to 1 intervention - of which ASSIST is the first listed.
NCT03903120 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03903120 about?
NCT03903120 is a clinical study titled "ASSIST: Treatment for Childhood Apraxia of Speech". Childhood apraxia of speech (CAS) is a pediatric motor speech disorder that impairs the planning of movements needed for intelligible speech. Children with CAS often show little or slow progress in standard speech therapy. This research is a Phase 1 study that tests initial efficacy and optimal para...
What is the current status of trial NCT03903120?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 420 participants. The study started on 2019-04-18. Estimated completion is 2025-03-31.
What conditions does trial NCT03903120 study?
This clinical trial studies the following conditions: Childhood Apraxia of Speech.
What interventions are being tested in trial NCT03903120?
The interventions under investigation include: ASSIST (BEHAVIORAL).
Who is sponsoring clinical trial NCT03903120?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03903120 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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