Trial Outcomes & Findings for Implementing FBT for Adolescent AN for Providers in Private Practice (NCT NCT04428580)
NCT ID: NCT04428580
Last Updated: 2025-08-29
Results Overview
Number of recruited subjects who provide full baseline data set at a rate of 50%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
1 day (day of baseline assessment)
Results posted on
2025-08-29
Participant Flow
1143 participants started the online screening process and 426 completed screening. 393 who completed the screen had sufficient information included in screening in order to assess eligibility. 151 participants signed informed consent, 123 were randomized.
Participant milestones
| Measure |
Online Training
Therapists receive enhanced online training in Family-Based Treatment (FBT)
|
Webinar Training
Therapists will receive online webinar training in Family-Based Treatment (FBT)
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
Started Training
|
61
|
62
|
|
Overall Study
Finished Training
|
58
|
59
|
|
Overall Study
Started Clinical Case Consultation
|
26
|
28
|
|
Overall Study
Completed Clinical Case Consultation
|
20
|
27
|
|
Overall Study
COMPLETED
|
61
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing FBT for Adolescent AN for Providers in Private Practice
Baseline characteristics by cohort
| Measure |
Online Training
n=61 Participants
Therapists receive enhanced online training in Family-Based Treatment (FBT)
|
Webinar Training
n=62 Participants
Therapists will receive online webinar training in Family-Based Treatment (FBT)
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (day of baseline assessment)Number of recruited subjects who provide full baseline data set at a rate of 50%
Outcome measures
| Measure |
Online Training
n=61 Participants
Therapists receive enhanced online training in Family-Based Treatment (FBT)
|
Webinar Training
n=62 Participants
Therapists will receive online webinar training in Family-Based Treatment (FBT)
|
|---|---|---|
|
Feasibility of Recruitment
|
61 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Week 12 (1 day at end of training)Number of recruited subjects who provide full post training data set at a rate of 50%
Outcome measures
| Measure |
Online Training
n=61 Participants
Therapists receive enhanced online training in Family-Based Treatment (FBT)
|
Webinar Training
n=62 Participants
Therapists will receive online webinar training in Family-Based Treatment (FBT)
|
|---|---|---|
|
Retention
|
48 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Baseline and Follow-up (after supervision)A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4).
Outcome measures
| Measure |
Online Training
n=61 Participants
Therapists receive enhanced online training in Family-Based Treatment (FBT)
|
Webinar Training
n=62 Participants
Therapists will receive online webinar training in Family-Based Treatment (FBT)
|
|---|---|---|
|
Exploring Association Between Fidelity and Outcome
|
7 Participants
|
9 Participants
|
Adverse Events
Online Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Webinar Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place