Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment

Avoidant / Restrictive Food Intake Disorder Clinical Trial

Official title:

Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778216
• Other study ID #: 40043
• Secondary ID: SPO 125881
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 7, 2019

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients ages 5-12 years old.

Description:

Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN) diagnosed with ARFID and their families will be recruited will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID program either immediately after their screening or 3 months after assessment (i.e., to a usual care group). FBT-ARFID consists of 22 sessions over a 6-month period. There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3 months into treatment, and EOT. There will be 4 major assessment time points for those in Usual Care: Baseline, transition to treatment (3 months after the usual care period is complete), 3 months into treatment, and EOT. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in ongoing qualitative assessments before treatment (BL), throughout treatment (every other session), and at EOT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 7, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• children meeting DSM-V criteria for ARFID
• children between the ages of 5 to 12 years old

Exclusion Criteria:

• 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
• a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)

Related Conditions & MeSH terms

• Avoidant / Restrictive Food Intake Disorder
• Disease

Intervention

Behavioral:
• Family Based Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Body Weight (EBW)	individual with ARFID's body weight at end of condition	following 6 months of treatment or 3 months of usual care
Secondary	Symptom Severity	individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.	following 6 months of treatment or 3 months of usual care