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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Avoidant / Restrictive Food Intake Disorder

Intervention / Treatment
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* Behavioral: Family Based Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FBT-ARFID<br>Family Based Treatment of child ARFID | Behavioral: Family Based Treatment<br> <br> * Other names: FBT-ARFID;|
| No Intervention: Usual Care<br>Continued usual care for ARFID with the exception of any Family Based Treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | following 6 months of treatment or 3 months of usual care |