Family Therapy for ARFID

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Psychotic illness, Drug dependence, Diabetes, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Family Therapy for ARFID?

Research on family therapy for conditions like asthma shows that it can improve family interactions and reduce hospital readmissions, suggesting it may help manage symptoms and improve outcomes. This indicates that family therapy could be beneficial for ARFID by enhancing family support and treatment adherence. ^{1 2 3 4 5}

Is Family Therapy for ARFID safe for humans?

Family-based treatment (FBT) has been used safely in various settings for different conditions, including pediatric obesity and eating disorders like anorexia nervosa and bulimia nervosa. While specific safety data for ARFID is limited, FBT is generally considered safe as it involves family support and behavioral strategies rather than medication. ^{6 7 8 9 10}

How is Family-Based Treatment (FBT) for ARFID different from other treatments?

Family-Based Treatment (FBT) for ARFID is unique because it involves the whole family in the treatment process, focusing on empowering parents to help their child overcome eating challenges. Unlike other treatments, FBT is adapted from its use in treating other eating disorders like anorexia nervosa and is tailored to address the specific needs of ARFID, such as sensory sensitivities or fear of eating. ^{6 7 9 11 12}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Family-based Treatment for ARFID (Behavioral Intervention)
• Manualized Non-Specific Usual Care for ARFID (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

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

Treating systemic issues in families affected by cystic fibrosis: A solution-focused approach. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Delayed diagnosis of avoidant/restrictive food intake disorder and autism spectrum disorder in a 14-year-old boy. [2023]

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

Feasibility and acceptability of a CF-specific cognitive-behavioral preventive intervention for adults integrated into team-based care. [2022]

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

Family Functioning and Treatment Adherence in Children and Adolescents with Cystic Fibrosis. [2021]

5. Austria pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. Canada 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Weight gain and parental self-efficacy in a family-based partial hospitalization program. [2022]

9. 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]

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

Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study. [2022]

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

Feasibility of conducting a randomized clinical trial using family-based treatment for avoidant/restrictive food intake disorder. [2019]

12. 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]