What side effects are associated with this type of intervention?

Family therapy for Avoidant/Restrictive Food Intake Disorder (ARFID) generally has minimal side effects. The primary focus is on improving parental self-efficacy and involves parents actively participating in the treatment process. Potential side effects may include emotional stress or anxiety for both parents and children as they navigate changes in feeding practices and family dynamics. However, these side effects are typically mild and manageable with the support of a trained therapist.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of Avoidant/Restrictive Food Intake Disorder (ARFID). Current treatment approaches often focus on behavioral interventions, such as family therapy, which has shown promise in improving parental self-efficacy and subsequently the child's eating behaviors. Family therapy aims to involve parents actively in the treatment process, helping them develop strategies to support their child's nutritional intake and address feeding challenges.

What other types of research exist?

Promising novel alternatives to Family Therapy for ARFID patients include Cognitive-Behavioral Therapy (CBT), which targets maladaptive thinking patterns, and Dialectical Behavior Therapy (DBT), which focuses on emotional regulation and coping strategies. Additionally, Schema-Focused Cognitive Therapy, which addresses deep-seated cognitive schemas, and the Loughborough Eating Disorders Activity Program (LEAP), which addresses compulsive exercise, are potential alternatives. These therapies have shown efficacy in related eating disorders and may offer new avenues for treatment in 2024.

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Family Therapy for ARFID

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 4 sessions of FBT

Be younger than 18 years old

Must not have

Expected Body Weight (EBW) <75% or > 88%

4 or more sessions of FBT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all assessment time points (bl, 1 month, 2 months, eot, and 6-month follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if family therapy can help children aged 6-12 with eating problems. The therapy involves the whole family and aims to boost parents' confidence in feeding their children.

Who is the study for?

This trial is for children aged 6-12 with Avoidant/Restrictive Food Intake Disorder (ARFID) who are medically stable, have not had more than 3 sessions of Family-based Treatment (FBT), and are on a stable medication dose if needed. They must speak English fluently and live with their families.

What is being tested?

The study compares family therapy to usual care for ARFID in children. It aims to confirm if family therapy helps better by improving how parents feel about feeding their kids and identifying which patients benefit most from this approach.

What are the potential side effects?

Since the interventions involve psychotherapy rather than medication, side effects may include emotional distress or discomfort during treatment sessions but typically do not involve physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had fewer than 4 sessions of brain therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My body weight is either less than 75% or more than 88% of what is expected for my height.

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I have undergone 4 or more FBT sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all assessment time points (bl, 1 month, 2 months, eot, and 6-month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all assessment time points (bl, 1 month, 2 months, eot, and 6-month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and all assessment time points (bl, 1 month, 2 months, eot, and 6-month follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expected Body Weight (EBW)

Parental Feeding Behavior Assessment

Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)

Secondary study objectives

36-Item Short Form (SF-36)

Bandura's General Self-Efficacy Scale (GSES)

Beck Anxiety Inventory (BAI)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Family-based Treatment for ARFID(FBT-ARFID)Experimental Treatment1 Intervention

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 II: Manualized Non-Specific Usual Care for ARFID(NSC)Active Control1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Family therapy for Avoidant Restrictive Food Intake Disorder (ARFID) primarily works by improving parental self-efficacy, which is the parents' confidence in their ability to manage their child's feeding issues. This therapy involves educating parents about ARFID, teaching them effective feeding strategies, and providing support to reduce their anxiety and improve their skills in encouraging their child to eat a variety of foods. This is crucial for ARFID patients because parental behavior and attitudes significantly influence a child's eating habits and willingness to try new foods. By empowering parents, family therapy helps create a supportive and structured environment that can lead to better nutritional outcomes and reduce the severity of ARFID symptoms.

An evaluation of trial-based functional analyses of inappropriate mealtime behavior.Can we change binge eating behaviour by interventions addressing food-related impulsivity? A systematic review.I think I'm Going to be Sick: An Eight-Year-Old Boy with Emetophobia and Secondary Food Restriction.