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

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.

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Key information

Conditions

Avoidant / Restrictive Food Intake Disorder Avoidant Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Family Based Treatment

Behavioral

Other names: FBT-ARFID

Primary outcomes

Estimated Body Weight (EBW)

Time frame: following 6 months of treatment or 3 months of usual care

individual with ARFID's body weight at end of condition

Secondary outcomes

Symptom Severity

Time frame: following 6 months of treatment or 3 months of usual care

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Dec 19, 2018
Registry last updated: Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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