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NCT03803943 · ClinicalTrials.gov registry record · Phase 2
Early Communication Intervention for Toddlers With Hearing Loss
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT03803943: Completed Phase 2 study, sponsored by Northwestern University.
NCT03803943 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803943, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.
Primary Outcome
Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with high
Interventions
- BEHAVIORAL Parent-Implemented Communication Intervention (PICT)
- OTHER No Intervention - Business-as-usual control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2019-06-15 |
| Est. Completion | 2024-10-10 |
| Phase | Phase 2 |
What the finished NCT03803943 record still lists
NCT03803943 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Parent-Implemented Communication Intervention (PICT) is the first listed.
NCT03803943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03803943 about?
NCT03803943 is a clinical study titled "Early Communication Intervention for Toddlers With Hearing Loss". Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language out...
What is the current status of trial NCT03803943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2019-06-15. Estimated completion is 2024-10-10.
What interventions are being tested in trial NCT03803943?
The interventions under investigation include: Parent-Implemented Communication Intervention (PICT) (BEHAVIORAL), No Intervention - Business-as-usual control (OTHER).
Who is sponsoring clinical trial NCT03803943?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03803943's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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