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

NCT ID: NCT04450771

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2026-01-16

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.

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 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. Participants will then be randomized to FBT-ARFID with medical management for 14 sessions provided over 4 months or manualized Non-Specific Care (NSC) with medical management for 4 months. NSC will consist of 14 sessions over 4 months.

There will be 5 major assessment time points: Baseline, 1 month, 2 months, End Of Treatment (4 months), and 6-month post-treatment Follow-Up. Both the child and the parent will complete measures at these time points. In addition, parents will complete short survey assessments after each of the 14 treatment sessions.

Conditions

Avoidant/Restrictive Food Intake Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Family-based Treatment for ARFID(FBT-ARFID)

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.

Group Type: EXPERIMENTAL

Family-based Treatment for ARFID

Intervention Type: 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.

Manualized Non-Specific Usual Care for ARFID(NSC)

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.

Group Type: ACTIVE_COMPARATOR

Manualized Non-Specific Usual Care for ARFID

Intervention Type: 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.

Interventions

Family-based Treatment for ARFID

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.

Intervention Type: BEHAVIORAL

Manualized Non-Specific Usual Care for ARFID

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FBT-ARFID; NSC

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

James Dale Lock

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36460266 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH121292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

56878

Identifier Type: -

Identifier Source: org_study_id