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

Not Applicable
Active, not recruiting
Conditions
ARFID
Picky Eating
Eating Disorders in Children
Interventions
Behavioral: Family Assisted Diet (FAD)
Behavioral: Feeling and Body Investigator_ARFID Division (FBI-ARFID)
Registration Number
NCT05105308
Lead Sponsor
Duke University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
203
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Family Assisted Diet (FAD)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.
Feeling and Body Investigator_ARFID Division (FBI-ARFID)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.
Primary Outcome Measures
NameTimeMethod
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)Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment

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.

Secondary Outcome Measures
NameTimeMethod
Nutrition Quality as measured by 3-day 24-hour dietary recallsPost-Treatment (up to 30 weeks)

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.

Nutrition Quantity as measured by 3-day 24-hour dietary recallsPost-Treatment (up to 30 weeks)

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.

Psychosocial Functioning as measured by items on the PARDI3-Months Post-Treatment

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.

Body Mass Index (BMI) as measured by height and weight3-Months Post-Treatment

BMI will be measured by parents at home with scales and tape measures provided to them.

Trial Locations

Locations (1)

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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