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NCT01889108 · ClinicalTrials.gov registry record · Phase 1

Feasibility Study of SPEEDI

A Phase 1 study, sponsored by Virginia Commonwealth University.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT01889108: Completed Phase 1 study, sponsored by Virginia Commonwealth University.

NCT01889108 is a Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01889108, a Phase 1 study, has completed, sponsored by Virginia Commonwealth University.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.\[6\] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.

Primary Outcome

Assessment of motor development

Interventions

  • BEHAVIORAL SPEEDI

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2012-07
Est. Completion 2013-06
Phase Phase 1
Virginia Commonwealth University

558 total trials

What the finished NCT01889108 record still lists

NCT01889108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which SPEEDI is the first listed.

NCT01889108 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01889108 about?

NCT01889108 is a clinical study titled "Feasibility Study of SPEEDI". The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention prac...

What is the current status of trial NCT01889108?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-07. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01889108?

The interventions under investigation include: SPEEDI (BEHAVIORAL).

Who is sponsoring clinical trial NCT01889108?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01889108's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01889108, the US trial registry maintained by the National Library of Medicine. NCT01889108 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.