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

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Stanford University

Status

Completed

Conditions

Avoidant / Restrictive Food Intake Disorder

Treatments

Behavioral: Family Based Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03778216
40043
SPO 125881 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

28 participants in 2 patient groups

FBT-ARFID
Experimental group
Description:
Family Based Treatment of child ARFID
Treatment:
Behavioral: Family Based Treatment
Usual Care
No Intervention group
Description:
Continued usual care for ARFID with the exception of any Family Based Treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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