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

Duke University logo

Duke University

Status

Active, not recruiting

Conditions

ARFID
Eating Disorders in Children
Picky Eating

Treatments

Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID)
Behavioral: Family Assisted Diet (FAD)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05105308
Pro00103645
1R33MH121549-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

203 patients

Sex

All

Ages

60 to 119 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

203 participants in 2 patient groups

Family Assisted Diet (FAD)
Active Comparator group
Description:
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.
Treatment:
Behavioral: Family Assisted Diet (FAD)
Feeling and Body Investigator_ARFID Division (FBI-ARFID)
Experimental group
Description:
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.
Treatment:
Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ilana R Pilato, PhD; Nancy L Zucker, PhD

Data sourced from clinicaltrials.gov

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