About this trial
This study is a randomized controlled 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and Females ages 10-18 years old
Current ARFID assessed via Feeding and Eating Disorders Model from the "Enhanced" Structured Interview for DSM-5 (SCID-5)
Normal TSH or free T4 levels to rule out thyroid disease as cause of symptoms inclusionary for randomization
Negative celiac screening panel indicating no active celiac disease as cause of symptoms inclusionary for randomization
Disqualifiers
Patient requires weight restoration treatment (e.g., < 5th percentile of BMI, height, or weight for sex and age; patient has fallen off individual growth trajectory; patient's medical providers have recommended weight restoration) such that 15 sessions of CBT-AR is not appropriate
Pregnancy, breastfeeding, or recent initiation/cessation of estrogen-containing systemic contraceptives within 8 weeks of the pre-treatment study visit (as these could impact neuroimaging)
Current/history of psychosis via Mini-International Neuropsychiatric Interview child/adolescent version (MINI KID)
Substance/alcohol use disorder (active within the past month) via MINI KID
Trial design
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy for Avoidance Restrictive Food Intake Disorder (CBT-AR)
BehavioralCBT-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 for Avoidant/Restrictive Food Intake Disorder
BehavioralNutrition 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.
Treatment groups
Trial outcomes
Primary outcomes
Pica, ARFID, and Rumination Disorder Interview
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
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.
Secondary outcomes
General Nutrition Knowledge Questionnaire
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.
4-Day Food Record
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.
Sponsors and contacts
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