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NCT03044145 · ClinicalTrials.gov registry record · NA

The Cultural Formulation Interview-Engagement Aid

A NA study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT03044145: Completed NA study, sponsored by New York State Psychiatric Institute.

NCT03044145 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03044145, a NA study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study Summary

This study consists of two projects: Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and 9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician feedback in a pre-pilot trial. The study team will first train clinicians in the CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations, and then check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures. Following this the study team will revise the CFI-EA based on their feedback for the comparative open trial in Phase 2. Project 2: The study team will test the revised CFI-EA against treatment as usual in a pilot trial. 3 clinicians and 12-15 patients will be enrolled in each arm. As before, the study team will first train clinicians in the revised CFI-EA by reading over the CFI-EA treatment manual and practicing how they can use it in behavioral simulations. Then, the study team will check whether participants think they can do it (feasibility) and like it (acceptability) through standard measures, and in addition will also explore any initial effects on communication behaviors among patients and clinicians and treatment engagement based on treatment retention. The specific aims are: For Project 1: 1. To pretest the CFI-EA intervention in a mental health setting through a pre-pilot open trial that explores communication mechanisms of action in terms of communication behavior and cultural content, and 2. To revise the CFI-EA intervention based on patient and clinician feedback on its feasibility and acceptability. As real-world community stakeholders for whom the CFI-EA is being developed, patients and clinicians can provide helpful perspectives on how the CFI-EA can help clinicians tailor treatment plans around patient cultural views and treatment preferences to keep patients in care. The CFI-EA will be revised around areas of max

Primary Outcome

CFI-EA feasibility is defined as the number of participants who completed all three sessions of the CFI-EA intervention.

Interventions

  • BEHAVIORAL The Cultural Formulation Interview-Engagement Aid in Project 1
  • BEHAVIORAL The Cultural Formulation Interview-Engagement Aid Revised for Project 2
  • BEHAVIORAL Treatment as usual for Project 2

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2016-09-20
Est. Completion 2018-09-05
Phase NA

What the finished NCT03044145 record still lists

NCT03044145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which The Cultural Formulation Interview-Engagement Aid in Project 1 is the first listed.

NCT03044145 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03044145 about?

NCT03044145 is a clinical study titled "The Cultural Formulation Interview-Engagement Aid". This study consists of two projects: Project 1: The study team will create and refine the CFI-EA by enrolling 3 clinicians and 9-12 patients to test the CFI-EA's feasibility and acceptability from patient and clinician feedback in a pre-pilot trial. The study team will first train clinicians in the...

What is the current status of trial NCT03044145?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2016-09-20. Estimated completion is 2018-09-05.

What interventions are being tested in trial NCT03044145?

The interventions under investigation include: The Cultural Formulation Interview-Engagement Aid in Project 1 (BEHAVIORAL), The Cultural Formulation Interview-Engagement Aid Revised for Project 2 (BEHAVIORAL), Treatment as usual for Project 2 (BEHAVIORAL).

Who is sponsoring clinical trial NCT03044145?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03044145's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT03044145, the US trial registry maintained by the National Library of Medicine. NCT03044145 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.