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

203 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two new treatment programs designed to help young children with ARFID, a condition where kids don't eat enough or a variety of foods. The goal is to see if these programs can improve their eating habits and overall health. Timely treatment is crucial to prevent long-term health issues from poor nutrition.

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.

What data supports the effectiveness of the treatment Family Assisted Diet (FAD) for ARFID?

Research suggests that family-based treatments, which involve parents in the therapy process, show promise for treating ARFID in children. These treatments help parents support their child's eating habits and reduce changes they make to accommodate the child's eating difficulties. ^{1 2 3 4 5}

Is the treatment for ARFID safe for humans?

The research on treatments for ARFID, such as family-based therapy, suggests that they are generally safe, but more studies are needed to confirm their safety and effectiveness. ^{5 6 7 8 9}

How is the Family Assisted Diet (FAD) treatment for ARFID different from other treatments?

The Family Assisted Diet (FAD) treatment for ARFID is unique because it involves the active participation of family members in the dietary management of the patient, which is not a common approach in other treatments for ARFID. This method emphasizes family involvement to support and encourage the patient in overcoming picky eating habits, which can be particularly beneficial for children and adolescents. ^{2 7 10 11 12}

Research Team

Nancy L Zucker, PhD

Principal Investigator

Duke University

Guillermo Sapiro, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A scoping review of psychological interventions and outcomes for avoidant and restrictive food intake disorder (ARFID). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Childhood Avoidant/Restrictive Food Intake Disorder: Review of Treatments and a Novel Parent-Based Approach. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

SPACE-ARFID: A pilot trial of a novel parent-based treatment for avoidant/restrictive food intake disorder. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Adapting treatment in an eating disorder program to meet the needs of patients with ARFID: Three case reports. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. England 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. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Update on eating disorders: current perspectives on avoidant/restrictive food intake disorder in children and youth. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Current evidence for avoidant restrictive food intake disorder: Implications for clinical practice and future directions. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof-of-concept for children and adolescents. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of avoidant-restrictive food intake disorder in an older adult: A proof-of-concept case study. [2023]

12. United States 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. [2019]