NCT03778216

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

December 14, 2018

Last Update Submit

March 15, 2021

Conditions

Avoidant / Restrictive Food Intake Disorder

Outcome Measures

Primary Outcomes (1)

  • Estimated Body Weight (EBW)

    individual with ARFID's body weight at end of condition

    following 6 months of treatment or 3 months of usual care

Secondary Outcomes (1)

  • Symptom Severity

    following 6 months of treatment or 3 months of usual care

Study Arms (2)

FBT-ARFID

EXPERIMENTAL

Family Based Treatment of child ARFID

Behavioral: Family Based Treatment

Usual Care

NO INTERVENTION

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

Interventions

Family Based TreatmentBEHAVIORAL
Also known as: FBT-ARFID
FBT-ARFID

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children meeting DSM-V criteria for ARFID
  • children between the ages of 5 to 12 years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • James D Lock, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

January 1, 2017

Primary Completion

October 30, 2018

Study Completion

March 7, 2019

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share