Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03778216 |
Other study ID # |
40043 |
Secondary ID |
SPO 125881 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2017 |
Est. completion date |
March 7, 2019 |
Study information
Verified date |
March 2021 |
Source |
Stanford University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5,
no specialized intervention has yet been empirically studied. This randomized controlled
crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention,
Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients
ages 5-12 years old.
Description:
Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN)
diagnosed with ARFID and their families will be recruited will be recruited through Stanford
University, pediatricians, mental health experts, clinics treating EDs, and local parents'
groups. Those eligible for the program will be invited to read and sign informed consent
forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID
program either immediately after their screening or 3 months after assessment (i.e., to a
usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.
There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3
months into treatment, and EOT. There will be 4 major assessment time points for those in
Usual Care: Baseline, transition to treatment (3 months after the usual care period is
complete), 3 months into treatment, and EOT. Both the child and the parent will complete
measures at these time points. In addition, patients and parents will participate in ongoing
qualitative assessments before treatment (BL), throughout treatment (every other session),
and at EOT.