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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH129331 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study is a randomized controlledlinical trial, assessing the efficacy of cognitive- behavioral therapy (CBT-AR) and nutrition counseling for avoidant/restrictive food intake disorder (ARFID) for children and adolescents (ages 10-18 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-AR | Experimental | See intervention description |
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| Nutrition Counseling | Experimental | See intervention description |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) | Behavioral | CBT-AR is a four-stage modular treatment for ARFID delivered by a mental health clinician. The four stages include: 1) Psychoeducation and early change; 2) Treatment planning; 3) Addressing maintaining mechanisms; and 4) Relapse prevention. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Neophobia Scale | Validated 6-item version of the Food Neophobia Scale used to assess food neophobia on a scale from 1 to 7, with higher scores indicating higher levels of food neophobia. The lowest score possible is 7, indicating low food neophobia, and highest score possible is 42, indicating high food neophobia. | Change from baseline food neophobia measured at pre-treatment to after each weekly session of treatment and after the complete 15 weeks of treatment measured at post-treatment |
| Functional magnetic resonance imaging (fMRI) food cue paradigm | Used to measure neural activation in response to food cues. Higher scores indicate higher neural activation. There is no minimum or maximum for this measure. | Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| General Nutrition Knowledge Questionnaire (GNKQ) | A revised version of the General Nutrition Knowledge Questionnaire (GNKQ) used to evaluate knowledge of nutrition. Scores are gathered through a series of multiple-choice questions. The lowest score possible is 0, indicating low knowledge of nutrition, and the highest score possible is 14, indicating high knowledge of nutrition. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eating Disorders Clinical and Research Program | Boston | Massachusetts | 02139 | United States |
The investigators will upload de-identified data to the NIMH National Data Archive at the conclusion of the study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2025 | Jun 18, 2026 |
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| Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder | Behavioral | Nutrition counseling will be provided by skilled registered dietitians at the MGH Translational and Clinical Research Center (TCRC). Sessions focus on the foods necessary for a healthy diet, how to meet nutritional needs, how to incorporate healthy exercise, and support for making these changes. For participants ages 10-15 years, patients/guardians attend the sessions. For patients ages 16 and up, the therapy is individual. |
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| Pica, ARFID, and Rumination Disorder Interview (PARDI) | A semi-structured clinical interview assessing the symptoms and severity of Pica, ARFID, and Rumination Disorder. This interview is used to determine the presence and severity of each ARFID profile. Scores for each severity measure are assessed on a scale from 0 to 6, with higher scores indicating greater severity. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
| Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q) | A 32-item revised version of the Pica, ARFID, and Rumination Disorder Interview used to assess ARFID severity and presence of Pica or Rumination Disorder. Each item is assessed on a scale from 0 to 6, with higher scores indicating greater severity. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
| 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups. | A record of participant diet for four days prior to the Pre-Treatment Assessment and for another four days prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
| 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups. | A detailed recall of everything a participant has consumed during the 24 hours prior to the Pre-Treatment Assessment, and again prior to the Post-Treatment Assessment. Dietary information is calculated from the recorded foods. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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