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

NCT ID: NCT05105308

Last Updated: 2026-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2025-09-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Family Assisted Diet (FAD)

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.

Group Type: ACTIVE_COMPARATOR

Family Assisted Diet (FAD)

Intervention Type: BEHAVIORAL

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

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

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.

Group Type: EXPERIMENTAL

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

Intervention Type: 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.

Interventions

Family Assisted Diet (FAD)

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

Intervention Type: BEHAVIORAL

Feeling and Body Investigator_ARFID Division (FBI-ARFID)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FAD; FBI-ARFID

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Months
• Maximum Eligible Age: 119 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy L Zucker, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Guillermo Sapiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28826066 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30597590 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R33MH121549-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00103645

Identifier Type: -

Identifier Source: org_study_id