Avoidant / Restrictive Food Intake DisorderNCT03778216
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
A study testing Family Based Treatment in people with Avoidant / Restrictive Food Intake Disorder, run by Stanford University.
Trial summary
Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Avoidant / Restrictive Food Intake Disorder
- What is being tested?
- Family Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children meeting DSM-V criteria for ARFID
- children between the ages of 5 to 12 years old
Who cannot join
- any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
- a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)
About this study
Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients ages 5-12 years old.
Read the detailed description
Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN) diagnosed with ARFID and their families will be recruited will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID program either immediately after their screening or 3 months after assessment (i.e., to a usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.
There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3 months into treatment, and EOT. There will be 4 major assessment time points for those in Usual Care: Baseline, transition to treatment (3 months after the usual care period is complete), 3 months into treatment, and EOT. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in ongoing qualitative assessments before treatment (BL), throughout treatment (every other session), and at EOT.
- Being tested
- Family Based Treatment
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based TreatmentBehavioural
Also called FBT-ARFID
| Study group | Role | What they receive |
|---|---|---|
| FBT-ARFID | Experimental | Family Based Treatment of child ARFID Receives: Behavioral: Family Based Treatment |
| Usual Care | No intervention | Continued usual care for ARFID with the exception of any Family Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Body Weight (EBW)
individual with ARFID's body weight at end of condition
Measured: following 6 months of treatment or 3 months of usual care
Secondary outcomes (1)
Symptom Severity
individual with ARFID's symptom severity at end of condition according to the Pica, ARFID, and Rumination Disorder Interview (PARDI). The symptom severity subscale will be used where the higher the score, the greater the ARFID severity. A total of 17 items rated on a scale of 0 to 6 are included in this subscale and the average is reported.
Measured: following 6 months of treatment or 3 months of usual care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startJan 2017
- Primary completion30 Oct 2018
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avoidant / Restrictive Food Intake DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
- Investigators
- James D Lock, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778216
- Sponsor's protocol ID
- 40043
- Other IDs
- SPO 125881
- Status last verified
- Mar 2021
- First submitted
- 14 Dec 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
- ClinicalTrials.gov ID
- NCT03778216
- Acronym / sponsor ID
- 40043
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients ages 5-12 years old.
Detailed description
Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN) diagnosed with ARFID and their families will be recruited will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID program either immediately after their screening or 3 months after assessment (i.e., to a usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.
There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3 months into treatment, and EOT. There will be 4 major assessment time points for those in Usual Care: Baseline, transition to treatment (3 months after the usual care period is complete), 3 months into treatment, and EOT. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in ongoing qualitative assessments before treatment (BL), throughout treatment (every other session), and at EOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT-ARFID | Experimental | Behavioral: Family Based TreatmentFamily Based Treatment of child ARFID |
| Usual Care | No intervention | –Continued usual care for ARFID with the exception of any Family Based Treatment |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children meeting DSM-V criteria for ARFID
- children between the ages of 5 to 12 years old
Key exclusion criteria (2 listed)
- any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
- a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Based TreatmentAlso: FBT-ARFID | Behavioural | FBT-ARFID |
Primary outcome
Estimated Body Weight (EBW)
Time frame: following 6 months of treatment or 3 months of usual care
individual with ARFID's body weight at end of condition
1 secondary outcome
Symptom Severity
Time frame: following 6 months of treatment or 3 months of usual care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Lock, MD, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Treatment in people with Avoidant / Restrictive Food Intake Disorder, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Body Weight (EBW) (time frame: following 6 months of treatment or 3 months of usual care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.