Family Therapy for ARFID

Overseen By Hali Boyce, B.A.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Psychotic illness, Drug dependence, Diabetes, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of family therapy (Family-based Treatment for ARFID) to usual care for children aged 6 to 12 with Avoidant/Restrictive Food Intake Disorder (ARFID). The researchers seek to determine if family therapy can enhance parents' confidence in feeding their children and identify which children benefit most from this approach. Children who are medically stable and diagnosed with ARFID may be suitable candidates for this trial. As an unphased trial, it offers families a unique opportunity to contribute to the understanding and improvement of treatment options for ARFID.

Will I have to stop taking my current medications?

If you are taking medication for other conditions, you must be on a stable dose for at least 8 weeks before joining the study. If you need to stop a medication to participate, you must do so before starting the treatment.

What prior data suggests that family therapy is safe for children with ARFID?

Research has shown that Family-Based Treatment (FBT) for Avoidant/Restrictive Food Intake Disorder (ARFID) employs methods similar to those used for other eating disorders like anorexia and bulimia. Studies have found these methods to be well-accepted. For instance, one case report described how FBT successfully helped a 9-year-old with ARFID by involving parents and encouraging supportive changes in eating habits.

FBT equips parents with tools to assist their children, improving eating habits without serious side effects. This approach avoids medication and invasive procedures, making it generally safer. It includes family sessions and guidance from therapists during meals to encourage positive eating changes.

Overall, FBT for ARFID has been used without major negative effects, suggesting it is a safe option for children dealing with this disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Family-based Treatment for ARFID (FBT-ARFID) because it directly involves parents in the treatment process, empowering them to take charge of their child's eating behaviors in a structured manner. Unlike typical approaches for ARFID, which often focus on individual therapy, FBT-ARFID uses a family-centered method that encourages changes at home, with therapists actively observing and guiding family meals. This approach is unique as it emphasizes parental empowerment and includes a two-phase structure that transitions responsibility to the child over time, potentially leading to more sustainable changes in eating patterns.

What evidence suggests that family therapy might be an effective treatment for ARFID?

Research has shown that a family-based treatment adapted for ARFID (Avoidant/Restrictive Food Intake Disorder), which participants in this trial may receive, can improve eating habits in children with this condition. In past studies, this method helped more children develop healthy eating patterns compared to other treatments. Specifically, one study found that children who received family-based treatment were more likely to overcome their symptoms than those who received standard supportive therapies. This treatment empowers parents to change their child's eating habits and has proven effective for children with sensory sensitivities. Overall, early evidence suggests this approach might work better than the Manualized Non-Specific Usual Care for ARFID, another treatment option in this trial. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine

I have been on the same dose of medication for my other health conditions for at least 2 months.

You weigh between 75% and 88% of what is considered a healthy weight for your height.

Exclusion Criteria

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

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

Current physical, psychotic illness or other mental illness requiring hospitalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either FBT-ARFID or NSC with medical management for 14 sessions over 4 months

4 months

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person) at 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Family-based Treatment for ARFID
• Manualized Non-Specific Usual Care for ARFID

Trial Overview 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.

How Is the Trial Designed?

Group I: Family-based Treatment for ARFID(FBT-ARFID) Experimental Treatment 1 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 Control 1 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.

Family-based Treatment for ARFID is already approved in United States for the following indications:

Approved in United States as Family-Based Treatment for:

• Avoidant/Restrictive Food Intake Disorder (ARFID)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 98 participants with anorexia nervosa, those in a family-based partial hospitalization program (PHP) experienced significant weight gain, averaging 4.5 kg (8.3% of expected body weight) within the first five weeks.

Maternal self-efficacy also improved significantly within two weeks of treatment, indicating that family-based PHPs can support both weight restoration and parental confidence without compromising the latter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight gain and parental self-efficacy in a family-based partial hospitalization program. Van Huysse, JL., Lock, J., Le Grange, D., et al.[2022]

Avoidant Restrictive Food Intake Disorder (ARFID) is a newly recognized eating disorder with high prevalence, particularly among individuals with Autism Spectrum Disorder (ASD), highlighting the need for effective treatment models.

The combined approach of Family Based Treatment (FBT) and the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) shows promise in personalizing care for young patients with ARFID and ASD, as demonstrated in two clinical cases that illustrate the unique challenges and benefits of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Presentations Combining Family-Based Treatment with the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents for Comorbid Avoidant Restrictive Food Intake Disorder and Autism Spectrum Disorder. Burton, C., Allan, E., Eckhardt, S., et al.[2021]

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]

Cystic fibrosis (CF) significantly impacts families, causing stress due to the chronic nature of the disease and the need for lifelong treatment.

Solution-focused brief therapy (SFBT) is proposed as an effective and adaptable approach to help families cope with the psychosocial stress associated with CF, supported by its empirical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating systemic issues in families affected by cystic fibrosis: A solution-focused approach. Hall, GN., Sanders, D., Noel, C., et al.[2021]

Individuals with Avoidant/Restrictive Food Intake Disorder (ARFID) often have psychiatric comorbidities, which can complicate the diagnosis process.

These comorbidities may lead to delays in diagnosis and negatively impact the long-term outcomes for affected children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed diagnosis of avoidant/restrictive food intake disorder and autism spectrum disorder in a 14-year-old boy. Rajendram, R., Psihogios, M., Toulany, A.[2023]

In a study of 19 children with cystic fibrosis, it was found that better family functioning is linked to improved adherence to antibiotic treatments, suggesting that family dynamics play a crucial role in managing the illness.

The study also revealed that older children tended to have better family functioning, indicating that age may influence how family interactions affect treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Functioning and Treatment Adherence in Children and Adolescents with Cystic Fibrosis. Everhart, RS., Fiese, BH., Smyth, JM., 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]

The study assessed the feasibility of a randomized clinical trial comparing Family-based Treatment for ARFID (FBT-ARFID) to usual care, successfully recruiting 28 children with a 21% attrition rate, indicating that families found FBT-ARFID acceptable.

Results showed moderate to large effect sizes favoring FBT-ARFID in improving weight and reducing eating-related psychopathology, along with significant improvements in parental self-efficacy, suggesting that FBT-ARFID may be an effective treatment for ARFID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of conducting a randomized clinical trial using family-based treatment for avoidant/restrictive food intake disorder. Lock, J., Sadeh-Sharvit, S., L'Insalata, A.[2019]

Family-based behavioral treatment (FBT) is being tested for effectiveness in pediatric primary care settings, involving 528 families with children who are overweight or obese, over a 24-month period.

The study aims to show that FBT will lead to better weight management outcomes for children and their parents compared to usual care, potentially making this evidence-based treatment more accessible in everyday healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study. Epstein, LH., Schechtman, KB., Kilanowski, C., et al.[2022]

The CF-specific cognitive-behavioral therapy (CF-CBT) was found to be feasible and acceptable for adults with mild depression and/or anxiety, with high engagement and treatment fidelity during the 8-session program involving 14 participants.

Preliminary effectiveness results showed significant improvements in depressive symptoms and quality of life, particularly in vitality and relaxation skills, suggesting that CF-CBT could be a valuable addition to integrated care for cystic fibrosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a CF-specific cognitive-behavioral preventive intervention for adults integrated into team-based care. Friedman, D., Smith, BA., Bruce, A., et al.[2022]

A treatment plan integrating systemic family therapy into pediatric asthma management has been developed and validated, focusing on coping and family interaction to help manage asthma symptoms.

After conducting 66 family therapy sessions with 11 families over a mean observation period of two years, there was a significant reduction in hospital readmissions for asthmatic patients, suggesting improved control of asthma symptoms even among families that only attended the initial session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bronchial asthma and systematic family therapy: treatment concept, initial contact and therapy follow-up]. Rathner, G., Messner, K.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839641/

Protocol for a randomized clinical trial for Avoidant ... This study aims to assess whether Family-Based Treatment modified for ARFID (FBT-ARFID) is superior to PMT for children with low-weight ARFID, and whether its ...

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00350/full

Family-Based Treatment for a Preadolescent With Avoidant ... The following case report demonstrates how FBT was used to treat a 9-year-old patient with ARFID characterized by sensory sensitivity.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03599921

NCT03599921 | Treatment Outcome in Eating Disorders The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family- ...

4. amazon.com amazon.com/Family-Based-Treatment-Avoidant-Restrictive-Disorder/dp/0367486393

Family-Based Treatment for Avoidant/Restrictive Food ... This book provides guidance on assessment and treatment of ARFID using Family-Based Treatment (FBT), covering medical, nutritional, and psychiatric issues, and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5459462/

Family-based treatment of eating disorders in adolescents At the end of treatment, more patients in FBT were abstinent (39%) than in SPT (18%), and this difference remained significant at 6-month follow ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722920300833

A Cognitive-Behavioral Family-Based Protocol for the ... The current paper describes a flexible, cognitive-behavioral, family-oriented treatment approach that has been applied to each of these ARFID presentations ...

7. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-024-01021-z

Avoidant restrictive food intake disorder: recent advances in ... Family-Based Therapy (FBT), commonly utilized in the treatment of eating disorders in adolescents, particularly for AN and BN, focuses on ...