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Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03778216
Collaborator
(none)
28
Enrollment
2
Arms
26.1
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Based Treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Oct 30, 2018
Actual Study Completion Date :
Mar 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: FBT-ARFID

Family Based Treatment of child ARFID

Behavioral: Family Based Treatment
Other Names:
  • FBT-ARFID

    		•
    No Intervention: Usual Care

    Continued usual care for ARFID with the exception of any Family Based Treatment

    Outcome Measures

    Primary Outcome Measures

    1. Estimated Body Weight (EBW) [following 6 months of treatment or 3 months of usual care]

      individual with ARFID's body weight at end of condition

    Secondary Outcome Measures

    1. Symptom Severity [following 6 months of treatment or 3 months of usual care]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: James D Lock, MD, PhD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Dale Lock, Principal Investigator, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03778216
    Other Study ID Numbers:
    • 40043
    • SPO 125881
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Avoidant Restrictive Food Intake Disorder

    Study Results

    No Results Posted as of Mar 17, 2021