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NCT01343940 · ClinicalTrials.gov registry record · Phase 2
Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration
A Phase 2 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 402
- Enrollment target
NCT01343940: Completed Phase 2 study, sponsored by Boston Medical Center.
NCT01343940 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 402 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343940, a Phase 2 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 402 participants
- Enrollment target
Study Summary
Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner will reach infants and families through their routine health care visits during their first six months of life and provide them with support for unmet legal needs, screen infants for developmental problems, screen families for mental health problems, and improve families' knowledge of child development. The control group will receive training on safe sleep and safe transportation for their newborn.
Primary Outcome
Paper-and-pencil questionnaire completed by child's caregiver
Interventions
- BEHAVIORAL Project dulce
- BEHAVIORAL Safety intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01343940 record still lists
NCT01343940 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 2 interventions - of which Project dulce is the first listed.
NCT01343940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343940 about?
NCT01343940 is a clinical study titled "Strengthening Families and Reducing Risk Thru Developmental and Legal Collaboration". Project Dulce is designed to test a new approach to delivering family support, in the context of the primary care medical home. The target population to be served is infants between birth and 6 months old and their families who receive primary care at Boston Medical Center. A dulce family partner wi...
What is the current status of trial NCT01343940?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 402 participants. The study started on 2011-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01343940?
The interventions under investigation include: Project dulce (BEHAVIORAL), Safety intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01343940?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343940's enrollment target sits among peer trials
402 96th of 2000 higher than 1,905 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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