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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 10 Years and 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CBT-AR
  • Behavioral: Cognitive-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.
Experimental
Nutrition Counseling
  • Behavioral: Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
    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.

Recruiting Locations

Eating Disorders Clinical and Research Program
Boston, Massachusetts 02139
Contact:
Stefania Yee
617-724-0799
syee5@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Jennifer J Thomas, PhD
617-643-6306
jjthomas@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.