Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Primary Purpose
Avoidant / Restrictive Food Intake Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Based Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Avoidant / Restrictive Food Intake Disorder
Eligibility Criteria
Inclusion Criteria:
- children meeting DSM-V criteria for ARFID
- children between the ages of 5 to 12 years old
Exclusion Criteria:
- any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
- a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FBT-ARFID
Usual Care
Arm Description
Family Based Treatment of child ARFID
Continued usual care for ARFID with the exception of any Family Based Treatment
Outcomes
Primary Outcome Measures
Estimated Body Weight (EBW)
individual with ARFID's body weight at end of condition
Secondary Outcome Measures
Symptom Severity
individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03778216
Brief Title
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Official Title
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
March 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avoidant / Restrictive Food Intake Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FBT-ARFID
Arm Type
Experimental
Arm Description
Family Based Treatment of child ARFID
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Continued usual care for ARFID with the exception of any Family Based Treatment
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment
Other Intervention Name(s)
FBT-ARFID
Primary Outcome Measure Information:
Title
Estimated Body Weight (EBW)
Description
individual with ARFID's body weight at end of condition
Time Frame
following 6 months of treatment or 3 months of usual care
Secondary Outcome Measure Information:
Title
Symptom Severity
Description
individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.
Time Frame
following 6 months of treatment or 3 months of usual care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children meeting DSM-V criteria for ARFID
children between the ages of 5 to 12 years old
Exclusion Criteria:
any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Lock, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
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