Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R33MH121549-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Assisted Diet (FAD) | Active Comparator | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Assisted Diet (FAD) | Behavioral | A behavioral intervention consisting of helping parents renourish their child and conduct food exposures with new foods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
And any one or more of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy L Zucker, PhD | Duke University | Principal Investigator |
| Guillermo Sapiro, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28826066 | Background | 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. | |
| 30597590 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2023 | Dec 20, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| D000081010 | Food Fussiness |
| D001068 | Feeding and Eating Disorders |
| D013851 | Thinness |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D005182 | Flavin-Adenine Dinucleotide |
| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
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.
Not provided
Not provided
Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.
|
| Feeling and Body Investigator_ARFID Division (FBI-ARFID) | Behavioral | 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. |
|
|
| Baseline |
| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| 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) |
| 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 |
| 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) |
| 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) |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001835 | Body Weight |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |