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

Not Applicable
Completed
Conditions
Avoidant / Restrictive Food Intake Disorder
Interventions
Behavioral: Family Based Treatment
Registration Number
NCT03778216
Lead Sponsor
Stanford University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
Inclusion Criteria
  • children meeting DSM-V criteria for ARFID
  • children between the ages of 5 to 12 years old
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
FBT-ARFIDFamily Based TreatmentFamily Based Treatment of child ARFID
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Symptom Severityfollowing 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.

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