ARFID Therapies for Picky Eating

Overseen By Ilana R Pilato, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Appetite affecting

Disqualifiers: Severe intellectual disability, Anorexia, Bulimia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new programs designed to help young children with Avoidant Restrictive Food Intake Disorder (ARFID), a condition where children struggle to eat enough or a variety of foods. The study investigates whether these programs can improve eating habits and overall health. One treatment, the Family Assisted Diet (FAD), involves parents actively working with their child to set and reach food goals. The other, Feeling and Body Investigator_ARFID Division (FBI-ARFID), uses fun activities to help children understand their body and food sensations. Children aged 5 to 9 who have difficulty with eating, are underweight, or rely on nutritional supplements might be a good fit for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to innovative approaches that may improve children's eating habits and health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes children who are taking medications known to affect appetite.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both treatments studied for Avoidant Restrictive Food Intake Disorder (ARFID) have been checked for safety in children.

For the Family Assisted Diet (FAD), studies have found that similar family-based methods improve children's body weight and the variety of foods they eat. These methods are usually well-received, with parents playing a key role in creating and following plans to increase their child's food intake. Families have noticed less anxiety and a greater willingness in children to try new foods, indicating that this approach is safe and manageable.

The Feeling and Body Investigator–ARFID Division (FBI-ARFID) program has also been evaluated. This program uses fun characters and activities to help children understand their body signals and try different foods. Designed for kids aged 4 to 10, it focuses on accepting and trying new things. Previous studies found it to be safe, with no major problems reported. Children have shown better eating habits and a clearer understanding of their body's signals.

Overall, both treatments appear safe for children, with no major safety concerns reported in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Assisted Diet (FAD) and Feeling and Body Investigator_ARFID Division (FBI-ARFID) because these approaches offer unique, family-centered interventions for managing Avoidant Restrictive Food Intake Disorder (ARFID). Unlike standard care options that might rely on general nutritional counseling or cognitive-behavioral therapy, FAD directly involves parents in setting and achieving specific re-nourishment goals, addressing barriers, and ensuring ongoing support. Meanwhile, FBI-ARFID introduces an innovative method using playful characters to educate children about body sensations and food features, which encourages experiential learning through sensory exercises and decision-tree worksheets. These distinct approaches aim to create a more engaging and supportive environment for children to explore and expand their food preferences.

What evidence suggests that this trial's treatments could be effective for ARFID?

This trial will compare two treatments for ARFID. Research has shown that family-based treatments, such as the Family Assisted Diet (FAD), one of the treatments in this trial, can help with ARFID. Studies indicate that involving parents in setting goals and strategies for their child's eating habits leads to better food intake and more variety in their diet. This approach has helped children overcome eating difficulties and develop healthier eating habits.

For the Feeling and Body Investigator ARFID Division (FBI-ARFID), another treatment option in this trial, early results suggest that teaching children to understand their body's signals can be beneficial. By trying different foods and paying attention to how their body feels, children become more comfortable and less fearful of new foods. This program aims to increase the variety of foods children eat and reduce their anxiety about food. Both treatments focus on involving families and addressing the specific challenges children face with eating. ^{1 6 7 8 9}

Who Is on the Research Team?

Nancy L Zucker, PhD

Principal Investigator

Duke University

Guillermo Sapiro, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children aged 5 to almost 10 years with ARFID, who rely on supplements for calories and show significant picky eating. They must be English-speaking and not taking appetite-affecting meds, have no severe intellectual disability or other eating disorders like anorexia or bulimia, and not be in another ARFID treatment study.

Inclusion Criteria

Dependent on nutritional supplements to achieve sufficient calories for optimal growth

Score of 29 or above on the Child Food Neophobia Scale

Avoiding activities due to eating rated at least almost always

Exclusion Criteria

I have been diagnosed with anorexia nervosa or bulimia nervosa.

I am currently in a study or receiving treatment for ARFID.

I am on medication that affects my appetite.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 20-session intervention with their parents, focusing on renourishment goals and sensory features of foods

20 weeks

20 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nutrition quantity, quality, BMI, and psychosocial functioning

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family Assisted Diet (FAD)
• Feeling and Body Investigator_ARFID Division

Trial Overview

The study tests two programs: Family Assisted Diet (FAD) and Feeling & Body Investigator_ARFID Division, designed to help young kids with ARFID eat better. It aims to find out if these treatments can improve the variety of foods they eat without causing stress.

How Is the Trial Designed?

Group I: Feeling and Body Investigator_ARFID Division (FBI-ARFID) Experimental Treatment 1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food.

Group II: Family Assisted Diet (FAD) Active Control 1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A case study of a 71-year-old male with Avoidant Restrictive Food Intake Disorder (ARFID) showed that after eight sessions of Cognitive Behavioral Therapy for ARFID (CBT-AR), he experienced significant reductions in ARFID symptoms and no longer met the diagnostic criteria for the disorder.

The patient also increased his oral food intake and successfully had his feeding tube removed, suggesting that CBT-AR may be an effective treatment option for older adults and those with feeding tubes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of avoidant-restrictive food intake disorder in an older adult: A proof-of-concept case study. Grunewald, W., Smith, AR., Brown, TA.[2023]

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR) was found to be feasible and acceptable, with 85% of participants rated as 'much improved' or 'very much improved' after treatment.

The treatment led to significant decreases in ARFID severity scores and an average weight gain of 11.5 pounds in the underweight subgroup, with 70% of patients no longer meeting the criteria for ARFID post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof-of-concept for children and adolescents. Thomas, JJ., Becker, KR., Kuhnle, MC., et al.[2021]

A family-based treatment (FBT) adapted for Avoidant/Restrictive Food Intake Disorder (ARFID) was successfully used to treat a 9-year-old patient, resulting in significant symptom improvement and weight gain over 17 sessions in 6 months.

While FBT for ARFID shares key interventions with FBT for anorexia nervosa, it requires tailored approaches to address the unique challenges of ARFID, especially when sensory sensitivity is a factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatment for a Preadolescent With Avoidant/Restrictive Food Intake Disorder With Sensory Sensitivity: A Case Report. Rosania, K., Lock, J.[2022]

Family-based treatment (FBT) is effective for pre-adolescents with avoidant/restrictive food intake disorder (ARFID), as demonstrated through three case reports highlighting different clinical presentations of the disorder.

The principles of FBT, such as parental empowerment and a focus on practical behavioral strategies, can be adapted to address common challenges faced by families dealing with ARFID, including promoting urgency and managing co-morbid psychiatric issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying family-based treatment (FBT) to three clinical presentations of avoidant/restrictive food intake disorder: Similarities and differences from FBT for anorexia nervosa. Lock, J., Robinson, A., Sadeh-Sharvit, S., et al.[2019]

In a case series of six patients with avoidant/restrictive food intake disorder (ARFID), all patients achieved their goal weight by the end of treatment, highlighting the effectiveness of a combined approach that included medical monitoring, family therapy, and medication.

All patients presented with severe co-morbid anxiety, indicating that addressing mental health alongside ARFID treatment is crucial for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of children and adolescents with avoidant/restrictive food intake disorder: a case series examining the feasibility of family therapy and adjunctive treatments. Spettigue, W., Norris, ML., Santos, A., et al.[2023]

Citations

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