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

NCT ID: NCT03778216

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-03-07

Brief 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.

Detailed 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.

Conditions

Avoidant / Restrictive Food Intake Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FBT-ARFID

Family Based Treatment of child ARFID

Group Type: EXPERIMENTAL

Family Based Treatment

Intervention Type: BEHAVIORAL

Usual Care

Continued usual care for ARFID with the exception of any Family Based Treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family Based Treatment

Intervention Type: BEHAVIORAL

Other Intervention Names

FBT-ARFID

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

James Dale Lock

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James D Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

SPO 125881

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

40043

Identifier Type: -

Identifier Source: org_study_id