# Confirming the Efficacy/Mechanism of Family Therapy for Children with Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)

> **NIH NIH R01** · STANFORD UNIVERSITY · 2020 · $709,636

## Abstract

Avoidant restrictive food intake disorder (ARFID) is a new psychiatric disorder in the Diagnostic and
Statistical Manual 5 (DSM-5). ARFID has an estimated prevalence of 7.2 to 17.4 percent thus making it a
significant mental health concern. ARFID is characterized by a range of dysfunctional eating behaviors including
a lack of interest in eating, sensory related eating concerns (such as taste, color or texture) and a fear of adverse
consequences of eating (i.e., fear of choking or vomiting). There is no evidence-based treatment for ARFID.
Preliminary data from a feasibility study comparing FBT-ARFID to Usual Care (UC) provide evidence that
manualized FBT adapted for patients with ARFID is feasible and effective. Recruitment and randomization
averaged 1.87 participants per month over a 15 month period with an overall attrition rate of 21%, comparable
to rates in fully powered studies of FBT-AN. The feasibility study also identified an efficacy signal on the
difference between groups on the primary outcome (change in percent Estimated Body Weight (%EBW)) of a
large effect size (ES) favoring FBT-ARFID Studies suggest that improvements in parental self-efficacy related to
changing feeding and eating behaviors early in treatment is a likely mechanism of FBT for other eating disorders
in youth. Our feasibility study showed a striking difference between conditions in parental self-efficacy favoring
FBT-ARFID compared to UC. In addition to this promising evidence of target engagement In addition, target
validation was demonstrated by the change in parental self-efficacy being significantly correlated with
improvements in % EBW. Aim 1: To conduct an RCT involving children and adolescents between the ages of 6
and 12 years of age with DSM 5 ARFID and weight below 88% of EBW comparing FBT-ARFID with medical
management to manualized Non-Specific Treatment UC with medical management. Treatments will be matched
for time and therapist attention. We hypothesize that participants randomized to FBT-ARFID will have
significantly greater change in %EBW at EOT. Aim 2: To examine early change in parental self-efficacy as a
mediator of treatment effect (FBT-ARFID vs. UC on outcome). We hypothesize that positive changes due to
FBT-ARFID in parental self-efficacy related to feeding behaviors using the Parents vs ARFID Scale (PvsARFID)
will be associated with positive changes in %EBW at EOT. Secondarily, we will explore whether objective
changes in parental re-feeding behavior is a possible mechanism of FBT-ARFID using a mediator analysis. Aim
3: To explore moderators of treatment outcome. To conduct an adequately powered study, 100 children (ages
6-12 years) will be randomized to manualized FBT-ARFID plus medical management (n=50) or manualized Non-
Specific Treatment plus medical management (n=50). Assessments (blinded to treatment condition) of primary
and secondary outcomes will be conducted at baseline, 1 month, 2 months, and 4 months (EOT).

## Key facts

- **NIH application ID:** 10039552
- **Project number:** 1R01MH121292-01A1
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** JAMES D LOCK
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $709,636
- **Award type:** 1
- **Project period:** 2020-07-07 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10039552

## Citation

> US National Institutes of Health, RePORTER application 10039552, Confirming the Efficacy/Mechanism of Family Therapy for Children with Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID) (1R01MH121292-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10039552. Licensed CC0.

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