Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID

NCT04450771 | Completed DMC

• 2 other identifiers: 56878R01MH121292
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Avoidant/Restrictive Food Intake Disorder

Keywords

FBT; Family Based Treatment; ARFID

Outcome Measures

Primary Outcomes (3)

• Expected Body Weight (EBW)

  Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.

  Following 4 months of FBT-ARFID or NSC

• Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)

  A modification of the Parents versus Anorexia Nervosa Scale, a measure of parental self-efficacy at changing eating behaviors. The modifications to the scale are minor and consisted of changing the name of the disorder named in the scale's questions from AN to ARFID. This is a 7 item 5 point scale where higher scores mean greater parental self-efficacy.

  Following 4 months of FBT-ARFID or NSC

• Parental Feeding Behavior Assessment

  Meals at Baseline and Week 6 will be recorded and then coded for behaviors associated with successful re-feeding using a procedure developed for FBT.

  After week 6 of either arm in all participants.

Secondary Outcomes (13)

• The Pica, ARFID, Rumination Disorder Interview (PARDI)

  All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)

• Therapy Suitability and Patient Expectancy (TSPE)

  At the end of session 1 and every two weeks during treatment and NSC.

• Parenting Style Questionnaire (PSQ)

  Completed at baseline and EOT

• Center for Epidemiological Studies Depression Scale for Children (CES-DC)

  Completed by children at all major assessment timepoints.

• Revised Children's Manifest Anxiety Scale (RCMAS-2)

  Completed by children at all major assessment timepoints.

Study Arms (2)

Family-based Treatment for ARFID(FBT-ARFID)

EXPERIMENTAL

FBT-ARFID is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior. Early sessions focus on inciting parents to make changes and include a family meal that allows therapists to observe \& consult directly to mealtime behaviors. FBT-ARFID for children 12 and under is manualized and consists of 2 phases. The first phase is focused on parents taking charge \& changing the eating behaviors of their child that are maintaining ARFID. The second phase focuses on the child taking up in an age-appropriate way managing their eating consistent with the changes the parents have employed in phase 1. Fourteen 1-hour sessions will be conducted approximately weekly over 4 months. Throughout medical monitoring and weekly dietary consultation are available to the family.

Behavioral: Family-based Treatment for ARFID

Manualized Non-Specific Usual Care for ARFID(NSC)

ACTIVE COMPARATOR

A manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model that has been used in other RCTs with eating disorders as a comparison. NSC consists of sessions with the child alone and 5 parent-only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSC intervention is psychoeducation about health \& social impacts of restrictive eating and supporting parent \& child exploration of motivation to change eating patterns \& choices they make about changes to eating. The therapist does not initiate behavioral or cognitive interventions. Feelings about eating and making changes are explored in both the child and parent sessions. Medical and dietary advice are provided weekly.

Behavioral: Manualized Non-Specific Usual Care for ARFID

Interventions

Manualized Non-Specific Usual Care for ARFID BEHAVIORAL

This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.

Also known as: NSC

Manualized Non-Specific Usual Care for ARFID(NSC)

Family-based Treatment for ARFID BEHAVIORAL

This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.

Also known as: FBT-ARFID

Family-based Treatment for ARFID(FBT-ARFID)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Van Wye E, Matheson B, Citron K, Yang HJ, Datta N, Bohon C, Lock JD. Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth. Contemp Clin Trials. 2023 Jan;124:107036. doi: 10.1016/j.cct.2022.107036. Epub 2022 Nov 29.

  PMID: 36460266 DERIVED

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 30, 2020
• Study Start: December 1, 2020
• Primary Completion: July 13, 2025
• Study Completion: January 16, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)