Trial Outcomes & Findings for The Cultural Formulation Interview-Engagement Aid (NCT NCT03044145)

Last Updated: 2026-06-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

After the third session, approximately 1 month after the first session.

Results posted on

2026-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	CFI-EA Arm in Project 1 - Patients This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 1 - Clinicians This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the clinician arm.	CFI-EA Arm in Project 2 - Patients This was the pilot trial when we tested the revised CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 2 - Clinicians This was the pilot trial when we tested the revised CFI-EA intervention. This is the clinician arm.	Treatment as Usual Arm in Project 2 - Patients This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the patient arm.	Treatment as Usual Arm in Project 2 - Clinicians This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the clinician arm.
Overall Study STARTED	9	3	18	3	18	3
Overall Study COMPLETED	8	3	12	3	12	3
Overall Study NOT COMPLETED	1	0	6	0	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CFI-EA Arm in Project 1 - Patients This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 1 - Clinicians This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the clinician arm.	CFI-EA Arm in Project 2 - Patients This was the pilot trial when we tested the revised CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 2 - Clinicians This was the pilot trial when we tested the revised CFI-EA intervention. This is the clinician arm.	Treatment as Usual Arm in Project 2 - Patients This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the patient arm.	Treatment as Usual Arm in Project 2 - Clinicians This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the clinician arm.
Overall Study Withdrawal by Subject	1	0	6	0	6	0

Baseline Characteristics

The Cultural Formulation Interview-Engagement Aid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CFI-EA Arm in Project 1 - Patients n=9 Participants This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 1 - Clinicians n=3 Participants This was the pre-pilot trial when we developed and tested the CFI-EA intervention. This is the clinician arm.	CFI-EA Arm in Project 2 - Patients n=18 Participants This was the pilot trial when we tested the revised CFI-EA intervention. This is the patient arm.	CFI-EA Arm in Project 2 - Clinicians n=3 Participants This was the pilot trial when we tested the revised CFI-EA intervention. This is the clinician arm.	Treatment as Usual Arm in Project 2 - Patients n=18 Participants This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the patient arm.	Treatment as Usual Arm in Project 2 - Clinicians n=3 Participants This is the treatment as usual arm. This was the comparator arm. It did not receive the CFI-EA intervention. This is the clinician arm.	Total n=54 Participants Total of all reporting groups
Age, Continuous	39.3 Years STANDARD_DEVIATION 19.1 • n=20 Participants	44.6 Years STANDARD_DEVIATION 6.1 • n=20 Participants	29.6 Years STANDARD_DEVIATION 11.5 • n=40 Participants	44.6 Years STANDARD_DEVIATION 6.1 • n=6 Participants	34.1 Years STANDARD_DEVIATION 12.5 • n=7 Participants	51.4 Years STANDARD_DEVIATION 10.9 • n=13 Participants	29.7 Years STANDARD_DEVIATION 21.8 • n=6 Participants
Sex: Female, Male Female	5 Participants n=20 Participants	2 Participants n=20 Participants	12 Participants n=40 Participants	2 Participants n=6 Participants	10 Participants n=7 Participants	3 Participants n=13 Participants	34 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=20 Participants	1 Participants n=20 Participants	6 Participants n=40 Participants	1 Participants n=6 Participants	8 Participants n=7 Participants	0 Participants n=13 Participants	20 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants	1 Participants n=6 Participants	2 Participants n=7 Participants	1 Participants n=13 Participants	8 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	3 Participants n=20 Participants	0 Participants n=20 Participants	6 Participants n=40 Participants	0 Participants n=6 Participants	6 Participants n=7 Participants	0 Participants n=13 Participants	15 Participants n=6 Participants
Race (NIH/OMB) White	2 Participants n=20 Participants	2 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	2 Participants n=13 Participants	10 Participants n=6 Participants
Race (NIH/OMB) More than one race	3 Participants n=20 Participants	0 Participants n=20 Participants	9 Participants n=40 Participants	0 Participants n=6 Participants	9 Participants n=7 Participants	0 Participants n=13 Participants	21 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: After the third session, approximately 1 month after the first session.

Population: This analysis was only performed in the CFI-EA Arm Patients in Project 2 Arm/Group. Two CFI-EA discontinued treatment and did not return for Session 2 despite meeting inclusion criteria. At Session 3, 2 patients in each arm became ineligible to participate after leaving New York City. CFI-EA clinicians referred 2 patients for substance abuse services based on their treatment preferences.

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

Outcome measures

Outcome measures
Measure	CFI-EA Arm in Project 2 - Patients n=18 Participants These were patients who received the revised CFI-EA in Project 2
CFI-EA Feasibility	12 Participants

PRIMARY outcome

Timeframe: After the third session, approximately 1 month after the first session for Project 2.

Population: 18 participants began Session 1. 12 patients remained for Session 3. Therefore, CSQ-8 scores are reported for these 12 patients.

This analysis was only performed in the CFI-EA Arm Patients in Project 2 Arm/Group. CFI-EA acceptability is defined as patient scores on the 8-item Client Satisfaction Questionnaire (CSQ-8) which measures the construct of client satisfaction. A total score is reported, ranging from a minimum of 8 to a maximum of 32. Higher values represent a better outcome. This is only measured for patients in the CFI-EA arm enrolled in Project 2.

Outcome measures

Outcome measures
Measure	CFI-EA Arm in Project 2 - Patients n=12 Participants These were patients who received the revised CFI-EA in Project 2
CFI-EA Acceptability	28.5 Scores on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 2 months after the last session of the CFI-EA in Project 2

Population: This analysis was only performed in the CFI-EA Arm Patients in Project 2 Arm/Group. 12 participants were eligible to attend after appointment 3.

Defined as the number of eligible patients staying within treatment 2 months after the third and last session of the CFI-EA has been delivered