Status:
ACTIVE_NOT_RECRUITING
Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Conditions:
Avoidant/Restrictive Food Intake Disorder
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
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. ...
Detailed Description
Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight equal to or between 75 to 88% EBW who are medically stable for outpatient treatment and their families will be r...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 weight
- 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
- Suicidal
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04450771
Start Date
December 1 2020
End Date
January 31 2026
Last Update
December 15 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305