Clinical trial NCT05105308: Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
Official title: Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-11-03
Enrollment: 203
Sex: ALL
Minimum age (years): 60
Maximum age (years): 119
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
Secondary outcomes:
measure: Nutrition Quantity as measured by 3-day 24-hour dietary recalls
timeFrame: Baseline
measure: Nutrition Quantity as measured by 3-day 24-hour dietary recalls
timeFrame: Post-Treatment (up to 30 weeks)
measure: Psychosocial Functioning as measured by items on the PARDI
timeFrame: Baseline
measure: Psychosocial Functioning as measured by items on the PARDI
timeFrame: Post-Treatment (up to 30 weeks)
measure: Psychosocial Functioning as measured by items on the PARDI
timeFrame: 3-Months Post-Treatment
measure: Nutrition Quality as measured by 3-day 24-hour dietary recalls
timeFrame: Baseline
measure: Nutrition Quality as measured by 3-day 24-hour dietary recalls
timeFrame: Post-Treatment (up to 30 weeks)
measure: Body Mass Index (BMI) as measured by height and weight
timeFrame: Baseline
measure: Body Mass Index (BMI) as measured by height and weight
timeFrame: Weekly (up to 30 weeks)
measure: Body Mass Index (BMI) as measured by height and weight
timeFrame: Post-Treatment (up to 30 weeks)
measure: Body Mass Index (BMI) as measured by height and weight
timeFrame: 3-Months Post-Treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nancy L Zucker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Guillermo Sapiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.