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

ARFID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05105308
• Other study ID #: Pro00103645
• Secondary ID: 1R33MH121549-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Months to 119 Months

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders in Children
• Feeding and Eating Disorders

Intervention

Behavioral:
• Family Assisted Diet (FAD)
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)
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline
Secondary	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.	Post-Treatment (up to 30 weeks)
Secondary	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.	Baseline
Secondary	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.	Post-Treatment (up to 30 weeks)
Secondary	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.	3-Months Post-Treatment
Secondary	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.	Baseline
Secondary	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.	Post-Treatment (up to 30 weeks)
Secondary	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.	Baseline
Secondary	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.	Weekly (up to 30 weeks)
Secondary	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.	Post-Treatment (up to 30 weeks)
Secondary	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.	3-Months Post-Treatment