← Back to Search

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
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

Study Summary

This trial is testing whether family therapy is better than usual care for children with Avoidant/Restrictive Food Intake Disorder, and why it works.

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.Check my eligibility
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.See study design
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
Select...
I have had fewer than 4 sessions of brain therapy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Expected Body Weight (EBW)
Parental Feeding Behavior Assessment
Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)
Secondary outcome measures
36-Item Short Form (SF-36)
Bandura's General Self-Efficacy Scale (GSES)
Beck Anxiety Inventory (BAI)
+10 more

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.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,776 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,599 Total Patients Enrolled
2 Trials studying Avoidant Restrictive Food Intake Disorder
6,203 Patients Enrolled for Avoidant Restrictive Food Intake Disorder
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,255 Total Patients Enrolled
1 Trials studying Avoidant Restrictive Food Intake Disorder
28 Patients Enrolled for Avoidant Restrictive Food Intake Disorder

Media Library

Family-based Treatment for ARFID Clinical Trial Eligibility Overview. Trial Name: NCT04450771 — N/A
Avoidant Restrictive Food Intake Disorder Research Study Groups: Family-based Treatment for ARFID(FBT-ARFID), Manualized Non-Specific Usual Care for ARFID(NSC)
Avoidant Restrictive Food Intake Disorder Clinical Trial 2023: Family-based Treatment for ARFID Highlights & Side Effects. Trial Name: NCT04450771 — N/A
Family-based Treatment for ARFID 2023 Treatment Timeline for Medical Study. Trial Name: NCT04450771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to individuals over the age of seventy-five?

"As outlined in the eligibility criteria, 6 to 12 year-olds are qualified applicants for this trial. Additionally, there are 5 clinical trials tailored towards participants younger than 18 and one specifically designed for those over 65 years old."

Answered by AI

Are there presently any opportunities for participants to join this trial?

"Per information available on clinicaltrials.gov, this research endeavour is presently recruiting participants. It was initially posted in December of 2020 and has been updated as recently as May 11th 2022."

Answered by AI

How many participants are receiving treatment as part of this research?

"Affirmative. According to the information provided by clinicaltrials.gov, this medical study is seeking patients for participation and was first posted on December 1st 2020. The trial has been recently amended as of May 11th 2022 and seeks 100 participants at a single location."

Answered by AI

What objectives is this research endeavor striving to fulfill?

"This clinical trial, which is set to span over a four-month period and will measure the effectiveness of FBT-ARFID or NSC treatment for Avoidant/Restrictive Food Intake Disorder (ARFID), has several secondary outcomes. These include Helping Relationship Questionnaire (HRQ) which evaluates the therapist-patient relationship; Beck Anxiety Inventory (BAI); and Beck Depression Inventory (BDI). The latter two are 21 item self report questionnaires that assess anxiety levels and depression respectively, with questions regarding suicidal ideation included in BDI."

Answered by AI

Who is the best-suited population to take part in this medical experiment?

"This clinical trial seeks 100 juveniles with Avoidant Restrictive Food Intake Disorder, aged 6 to 12 years old. Prerequisites for participation include: no concurrent involvement in individual or family-based therapy during the duration of treatment sessions; a body weight between 75 and 88 percentiles; 8 weeks (2 months) of stabilized medication dose prior to enrolment for co-morbid disorders; fewer than 4 sessions of Family Based Therapy undertaken previously."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
James Dale Lock 2020. "Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04450771.
~26 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top