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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
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avoidant / Restrictive Food Intake Disorder

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 14, 2018
    Last Updated
    March 15, 2021
    Sponsor
    Stanford University
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    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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