An interventional study of Family Assisted Diet (FAD) and Feeling and Body Investigator_ARFID Division (FBI-ARFID) in ARFID, Picky Eating and Eating Disorders in Children, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 60 Months to 119 Months. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
40 studies on the registry are indexed under Avoidant Restrictive Food Intake Disorder; 12 are open to participants now.
This study's enrollment of 203 is above the median of 38 across 28 interventional studies indexed under Avoidant Restrictive Food Intake Disorder.
Browse Avoidant Restrictive Food Intake Disorder studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation.
Behavioral: Family Assisted Diet (FAD)
This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food.
Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID)
A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
Also known as: FAD
A sensory and somatic focused intervention that educates children about feelings and bodily sensations, in-session exposures to body and food sensations, different strategies to improve generalization while at home, and strategies to help them understand and track experiences exploring food.
Also known as: FBI-ARFID
Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)
The 17-item PARDI measures symptoms including body mass index, diet quality, dependence on supplement use for sufficient calories, and psychosocial impairment. Each item assesses a symptom on a 0 - 6 scale, with scores above 4 indicating that it is a clinically severe symptom.
Time frame: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Nutrition Quantity is measured by two weekdays and one weekend day assisted dietary recall with the parent of the child. Using the Harris-Benedict equation to determine a child's nutritional needs, the following will be measured: 1) Child unable to meet daily energy requirements without supplement and/or 2) Child's dietary intake is below energy needs on all 3 days.
Time frame: Baseline
Nutrition Quantity as measured by 3-day 24-hour dietary recalls
Nutrition Quantity is measured by two weekdays and one weekend day assisted dietary recall with the parent of the child. Using the Harris-Benedict equation to determine a child's nutritional needs, the following outcomes will be measured: 1) Child unable to meet daily energy requirements without supplement and/or 2) Child's dietary intake is below energy needs on all 3 days.
Time frame: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Time frame: Baseline
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Time frame: Post-Treatment (up to 30 weeks)
Psychosocial Functioning as measured by items on the PARDI
Psychosocial functioning is measured by items on the PARDI indicating that the child does not avoid social events due to eating/food and less than or equal to 1 indicating that the child is able to remain at the table and demonstrate age-appropriate behaviors.
Time frame: 3-Months Post-Treatment
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Nutrition Quality is measured by the average macronutrient and micronutrient assessment from two weekdays and one weekend day assisted dietary recall with the parent of the child.
Time frame: Baseline
Nutrition Quality as measured by 3-day 24-hour dietary recalls
Nutrition Quality is measured by the average macronutrient and micronutrient assessment from two weekdays and one weekend day assisted dietary recall with the parent of the child.
Time frame: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Time frame: Baseline
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Time frame: Weekly (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Time frame: Post-Treatment (up to 30 weeks)
Body Mass Index (BMI) as measured by height and weight
BMI will be measured by parents at home with scales and tape measures provided to them.
Time frame: 3-Months Post-Treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2022 to primary completion in Sep 2025, 43 months.
Of 17 interventional studies with no phase under Avoidant Restrictive Food Intake Disorder, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 43 months is above that.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Avoidant Restrictive Food Intake Disorder →