ARFID, Eating Disorders in Children, Picky Eating
Conditions
Keywords
FBI-ARFID, Eating Disorder, Avoidant Restrictive Food Intake Disorder, Food Neophobia, Treatment for Children, Sensory Sensitivity, Picky Eating, Low Weight, Nutritional Deficiencies
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.
Interventions
BEHAVIORALFamily Assisted Diet (FAD)
A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods.
BEHAVIORALFeeling 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.
Sponsors
Duke University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.
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.
Eligibility
Sex/Gender
ALL
Age
60 Months to 119 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Quantity as measured by 3-day 24-hour dietary recalls | Baseline | 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. |
| Psychosocial Functioning as measured by items on the PARDI | Baseline | 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. |
| Nutrition Quality as measured by 3-day 24-hour dietary recalls | Baseline | 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. |
| Body Mass Index (BMI) as measured by height and weight | Baseline | BMI will be measured by parents at home with scales and tape measures provided to them. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy L Zucker, PhD
Duke University
PRINCIPAL_INVESTIGATORGuillermo Sapiro, PhD
Duke University
Outcome results
None listed