Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

NCT05105308 | Completed

• 2 other identifiers: Pro001036451R33MH121549-01A1
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARFID; Picky Eating; Eating Disorders in Children

Keywords

FBI-ARFID; Eating Disorder; Avoidant Restrictive Food Intake Disorder; Food Neophobia; Treatment for Children; Sensory Sensitivity; Picky Eating; Low Weight; Nutritional Deficiencies

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment

Secondary Outcomes (11)

• Nutrition Quantity as measured by 3-day 24-hour dietary recalls

  Baseline

• Nutrition Quantity as measured by 3-day 24-hour dietary recalls

  Post-Treatment (up to 30 weeks)

• Psychosocial Functioning as measured by items on the PARDI

  Baseline

• Psychosocial Functioning as measured by items on the PARDI

  Post-Treatment (up to 30 weeks)

• Psychosocial Functioning as measured by items on the PARDI

  3-Months Post-Treatment

Study Arms (2)

Family Assisted Diet (FAD)

ACTIVE COMPARATOR

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)

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

EXPERIMENTAL

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)

Interventions

Family Assisted Diet (FAD) BEHAVIORAL

A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.

Also known as: FAD

Family Assisted Diet (FAD)

Feeling and Body Investigator_ARFID Division (FBI-ARFID) BEHAVIORAL

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

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

Eligibility Criteria

• Age: 60 Months - 119 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
• English Speaking
• Consent given by parent and assent by child
• And any one or more of the following:
• Score of 29 or above on the Child Food Neophobia Scale
• Underweight
• Current diagnosis of ARFID
• Dependent on nutritional supplements to achieve sufficient calories for optimal growth
• Avoiding activities due to eating rated at least almost always

You may not qualify if:

• Child is known to have a severe intellectual disability based on medical chart review
• Meets diagnostic criteria for anorexia nervosa or bulimia nervosa
• Is currently enrolled in a treatment study or receiving active treatment for ARFID
• Taking medications known to affect appetite

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Zucker N, Mauro C, Craske M, Wagner HR, Datta N, Hopkins H, Caldwell K, Kiridly A, Marsan S, Maslow G, Mayer E, Egger H. Acceptance-based interoceptive exposure for young children with functional abdominal pain. Behav Res Ther. 2017 Oct;97:200-212. doi: 10.1016/j.brat.2017.07.009. Epub 2017 Jul 29.

  PMID: 28826066 BACKGROUND

• Zucker NL, LaVia MC, Craske MG, Foukal M, Harris AA, Datta N, Savereide E, Maslow GR. Feeling and body investigators (FBI): ARFID division-An acceptance-based interoceptive exposure treatment for children with ARFID. Int J Eat Disord. 2019 Apr;52(4):466-472. doi: 10.1002/eat.22996. Epub 2018 Dec 31.

  PMID: 30597590 BACKGROUND

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Food Fussiness; Feeding and Eating Disorders; Thinness; Malnutrition

Interventions

Flavin-Adenine Dinucleotide

Condition Hierarchy (Ancestors)

Mental Disorders; Feeding Behavior; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Riboflavin; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Pigments, Biological; Biological Factors

Study Officials

• Nancy L Zucker, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Guillermo Sapiro, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is a two-group (n=70 per group) randomized controlled trial. Primary outcomes including ARFID symptoms and secondary outcomes (e.g., responder status of weight gain) will be assessed at baseline, posttreatment, and 3-month follow-up, while abbreviated measures will be assessed every session.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: February 10, 2022
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)