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Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
Trial ID: NCT04450771
This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.
Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)
- Children meeting DSM-V criteria for ARFID
- Children between the ages of 6 to 12 years old, living with their families
- Medically stable for outpatient treatment according to the recommended thresholds of
the American Academy of Pediatrics and the Society of Adolescent Medicine.
- Not engaging in another individual or family-based psychotherapy trial during the
duration of treatment sessions in the study.
- Less than 4 sessions of FBT
- If taking medication for co-morbid disorders, participants must be on a stable dose of
medication for 8 weeks (2 months) before participating. If the participant is on a new
medication at baseline, but is discontinuing the medication in order to start the
study, they must have discontinued the medication before beginning treatment.
- EBW between 75% and 88%.
- Able to fluently speak and read English
- Current physical, psychotic illness or other mental illness requiring hospitalization
- Current psychotic illness or mental retardation or other mental illnesses that would
prohibit the use of psychotherapy
- Current dependence on drugs or alcohol
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or
- Any medical complications or severe mental disorder (psychosis, low-functioning
Autism) that may reduce compliance with the study procedures or require more intensive
care to manage the symptoms
- 4 or more sessions of FBT
- Currently taking medication for co-morbid disorders that cannot be safely discontinued
or prescribed for less than 2 months
- Medically unstable for outpatient treatment according to the recommended thresholds of
the American Academy of Pediatrics and the Society of Adolescent Medicine, defined as:
vital sign instability (heart rate less than 45 beats per minute), clinically
significant orthostatic blood pressure with changes usually greater than 35 points or
findings of gastrointestinal bleeding, dizziness, or syncope, IBW <75%, hypothermia
(body temperature less than 36 degrees centigrade), clinically significant electrolyte
abnormalities, or prolonged QTc on electrocardiogram
- Expected Body Weight (EBW) <75% or > 88%
- Unable to fluently speak and read English
- Parent excluded
- In the case of patients with current, or a history of sexual or physical abuse by
family members, perpetrators of the abuse will be excluded from treatment.
behavioral: Family-based Treatment for ARFID
behavioral: Manualized Non-Specific Usual Care for ARFID