Avoidant/Restrictive Food Intake Disorder (ARFID)
Conditions
Brief summary
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).
Interventions
BEHAVIORALCognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
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.
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.
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females ages 10-18 years old * Current ARFID * Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms * Negative celiac screening panel indicating no active celiac disease as cause of symptoms * Fluency and literacy in English
Exclusion criteria
* BMI \< 5th percentile for sex and age * Pregnancy, breastfeeding, or recent initiation/cessation of oral contraceptive pills within 8 weeks of the pre-treatment study visit * Current/history of psychosis * Substance/alcohol use disorder (active within the past month) * Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders * Laboratory abnormalities indicating a need for higher level of care * Complete lack of oral intake (suggesting a need for inpatient care) * Tube feeding (suggesting a need for tube weaning) * Active suicidal/homicidal ideation with intent or plan * Contraindications to MRI * History of major gastrointestinal tract surgery or serious medical condition (e.g., cancer) * Medical history of intellectual disability * Illiteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Neophobia Scale | 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 | 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. |
| Functional magnetic resonance imaging (fMRI) food cue paradigm | Change from baseline neural activation in response to food cues measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Nutrition Knowledge Questionnaire (GNKQ) | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
| Pica, ARFID, and Rumination Disorder Interview (PARDI) | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
| Pica, ARFID, and Rumination Disorder ARFID Questionnaire (PARDI-AR-Q) | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
| 4-Day Food Record measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
| 24-Hour Recall measuring percent of calories consumed from fruits, vegetables, proteins, grains, and dairy food groups. | Change from baseline measured at pre-treatment to after 15 weeks of treatment measured at post-treatment | 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. |
Countries
United States
Outcome results
None listed