- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05814653
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
November 13, 2023 updated by: Jocelyn R. Lebow, Mayo Clinic
Evaluating the Feasibility of a Primary Care-based Treatment for Restrictive Eating Disorders in Children and Adolescents in the Health System
The purpose of this study is to test the effectiveness of a new treatment for children and adolescents with eating disorders characterized by dietary restriction and/or weight loss or failure to gain expected weight.
The treatment, which is called Family-Based Treatment for Primary Care (or FBT-PC for short), is based on Family-Based Treatment, the gold standard outpatient eating disorder treatment for children and adolescents.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
In the United States, half a million adolescents suffer from an eating disorder.
With only 66 certified providers nationally, Family-Based Treatment (FBT), a first-line evidence-based treatment for adolescent eating disorders, is not readily available to most families.
This provider shortage leaves most young patients without care and undoubtedly contributes to the chronicity and lethality of these conditions.
Patients with eating disorders generally make their first contact with the healthcare system in primary care.
As such, equipping primary care providers (PCPs) with effective means to treat these patients has potential to democratize care, improve rates of early intervention, and enhance patient outcomes.
Family-Based Treatment for Primary Care (FBT-PC) is a novel intervention for delivery by a PCP in primary care that uses FBT strategies.
Data support proof-of-concept for this adaptation.
This study has several study aims.
(1) Finalize the FB-PC intervention through an open case series.
(2) Establish the feasibility and acceptability of FBT-PC for caregivers, patients, and PCPs in a pilot randomized controlled trial.
Finally, (3) to test preliminary target engagement of FBT-PC and determine whether it is associated with improved caregiver self-efficacy and, through this mechanism, symptom remission.
Remission will be defined as weight restoration to 95% of expected body weight and a score within 1 SD of community norms on the Eating Disorder Examination-Questionnaire. In addition, as (4) an exploratory aim analyses will be conducted to evaluate baseline characteristics of the sample to determine for whom the FBT-PC intervention is most beneficial.
To accomplish all aims an open case series (n = 6) will be conducted, followed by a pilot trial in which 40 patients (ages 7-18 years) with restrictive eating disorders and their caregiver(s) will be randomly assigned to FBT-PC or a control condition of standard FBT.
Families will attend up to 18 sessions over 6 months.
Goals from the open case series (Aim 1) will include the development of tools for FBT-PC training and implementation, including treatment and training protocols and fidelity measures.
Feasibility (Aim 2) will be assessed through an evaluation of recruitment and retention.
Acceptability (Aim 2) will be evaluated using mixed methods surveys and interviews of caregivers, patients and PCPs on the topics of tolerability, fit, and burden.
The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, to facilitate symptom remission will also be assessed (Aim 3).
Effect sizes will be calculated for FBT-PC with a goal of ≥ 0.5, comparable with those found in FBT trials.
Finally, baseline sample characteristics (Exploratory Aim) will be assessed including caregiver perceptions about their child's illness, referral method, length of illness, and symptom severity.
Once feasibility, acceptability, and target engagement of the FBT-PC intervention have been established, these findings will be used in support of a large pragmatic clinical trial to evaluate the noninferiority of effectiveness of FBT-PC versus standard FBT.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of a DSM-5 restrictive eating disorder (anorexia nervosa or other specified feeding or eating disorder characterized by dietary restriction and/or weight loss or failure to make expected weight gains).
- Eligible patients will have at least one caregiver who is also willing to participate in the study.
- Eligible patients must receive primary care through one of 3 MCHS sites connected to the study: Onalaska/La Crosse, Redwing, and Faribault.
Exclusion Criteria:
- Patients will be excluded who have received FBT in the past, and/or who report active suicidality.
- Patients who become physically or psychiatrically unstable during the study will be re-evaluated and referred for appropriate treatment.
- Patients will be excluded if their enrolled caregiver has active substance dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FBT-PC delivered by a primary care provider
Subjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months.
|
Novel treatment that borrows key intervention strategies from standard family-based treatment.
It uses trained primary care providers (PCPs), in consultation with a mental health provider, to deliver family-based treatment strategies in community-based clinics to increase caregiver self-efficacy to reverse their child's dietary restriction and weight loss.
Other Names:
|
Active Comparator: Standard FBT
Subjects will receive up to 18 session of FBT, delivered by a specialist mental health provider at Mayo Clinic in Rochester, MN over 6 months.
|
Delivered by a mental health provider in a traditional mental health or eating disorder specialty setting.
First-line evidence-based treatment for adolescent eating disorders that targets caregiver self-efficacy as a mechanism to facilitate weight restoration and ultimately symptom remission in adolescents.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recruitment across 3 years
Time Frame: Rate of recruitment at end of study (3 years)
|
Recruitment rate will be tracked, with a goal of enrollment of 75% of eligible participants.
|
Rate of recruitment at end of study (3 years)
|
Rate of retention across 3 years
Time Frame: Rate of retention at end of study (3 years)
|
Retention rate will be tracked, with a target retention rate (attendance at >80% of sessions) of 70%.
|
Rate of retention at end of study (3 years)
|
Mixed methods feedback survey at end of treatment (caregiver/patient)
Time Frame: Assessed after the final session (within 6 months)
|
This is a unique survey with quantitative (Likert scale rating/ yes/no questions) and qualitative (short answer) questions that assesses treatment satisfaction, acceptability of session frequency, length, and therapeutic alliance, as well as comfort and familiarity with treatment intervention components.
Higher scores on Likert scales indicate greater satisfaction/acceptability.
|
Assessed after the final session (within 6 months)
|
Rate of retention across 3 years
Time Frame: Rate of retention at end of study (3 years)
|
Rate of retention (defined as attendance at > 80% of sessions) will be tracked, with a target of <30% attrition.
|
Rate of retention at end of study (3 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parents versus Anorexia Scale (caregiver)
Time Frame: Monthly across the intervention (up to 6 months)
|
The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, will be assessed through this well-validated caregiver-report measure.
This is a 7-item of caregiver self-efficacy that has been widely used in the eating disorder treatment literature.
Items assess parental efficacy in the Maudsley model of family-based treatment for anorexia nervosa.
Scores range from 5-35, with higher scores indicated higher self efficacy
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Monthly across the intervention (up to 6 months)
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Parent Sense of Competency Scale (caregiver)
Time Frame: Monthly across the intervention (up to 6 months)
|
The degree to which FBT-PC engages the proposed mechanism of change, caregiver self-efficacy, will be assessed through this well-validated caregiver-report measure, a 17-item measure of general parenting competency beliefs.
Items are rated on a 1-6 Likert scale, with scores ranging from 17-102, with higher scores indicating higher parenting competency beliefs.
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Monthly across the intervention (up to 6 months)
|
Eating Disorder Symptom Reduction (patient)
Time Frame: Pre/post intervention (up to 6 months)
|
Patient weight restoration and reduction in behavioral/cognitive eating disorder symptoms as measured by the Eating Disorder Examination-Questionnaire or child Eating Disorder Examination-Questionnaire for patients ages 7-12.
Higher scores on the 4 subscales and Global scale of these measures range from 0-6, with higher scores indicating more severe eating disorder symptomology.
|
Pre/post intervention (up to 6 months)
|
Internalized Stigma of Mental Illness Scale (caregiver/patient)
Time Frame: Pre/post intervention (up to 6 months)
|
The internalized stigma of having an eating disorder will be measured by the Internalized Stigma of Mental Illness Scale, a 20-item measure.
This measure has been validated in populations of patients with eating disorders and will be modified to also be relevant for caregivers.
Items are rated 1-4, with possible scores ranging from 29-116.
Higher scores indicate higher internalized stigma.
|
Pre/post intervention (up to 6 months)
|
Treatment experience feedback survey- Year 1 (provider)
Time Frame: End of Year 1 of the study
|
Mixed methods surveys will be collected from primary care providers providing FBT-PC and within the participating practices, to assess their perceptions of their experience providing and referring to the intervention.
HIgher scores on quantitative items (Likert scales rated 1-5) will indicated greater satisfaction.
|
End of Year 1 of the study
|
Treatment experience feedback survey- Year 2 (provider)
Time Frame: End of Year 2 of the study
|
Mixed methods surveys will be collected from primary care providers providing FBT-PC and within the participating practices, to assess their perceptions of their experience providing and referring to the intervention.
HIgher scores on quantitative items (Likert scales rated 1-5) will indicated greater satisfaction.
|
End of Year 2 of the study
|
Qualitative treatment experience feedback interview- Year 1 (provider)
Time Frame: End of Year 1 of the study
|
30-60 minute semi-structured interviews will be conducted with primary care providers providing FBT-PC and within the participating practices, to assess their experience with the treatment (these will be open-ended qualitative questions)
|
End of Year 1 of the study
|
Qualitative treatment experience feedback interview- Year 2 (provider)
Time Frame: End of Year 2 of the study
|
30-60 minute semi-structured interviews will be conducted with primary care providers providing FBT-PC and within the participating practices, to assess their experience with the treatment (these will be open-ended qualitative questions)
|
End of Year 2 of the study
|
Qualitative treatment experience feedback interview (caregiver)
Time Frame: At the end of their study participation (up to 6 months)
|
Qualitative interviews will be conducted with a purposive combined sample of 10 caregivers from both arms, assessing their experience with both treatments and areas of ongoing need.
These will be open-ended qualitative questions.
|
At the end of their study participation (up to 6 months)
|
Qualitative treatment experience feedback interview (patient)
Time Frame: At the end of their study participation (up to 6 months)
|
Qualitative interviews will be conducted with a purposive combined sample of 10 patients from both arms, assessing their experience with both treatments and areas of ongoing need.
These will be open-ended qualitative questions.
|
At the end of their study participation (up to 6 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Questionnaire (caregiver)
Time Frame: Pre/post intervention (up to 6 months)
|
Questionnaire evaluating family expressed emotion.
Items are scored on a 1-4 Likert scale, and higher scores indicated higher expressed emotion.
The authors give a cutpoint of 23 for an indication of high Critical Comments and 27 for high Emotional Overinvolvement
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Pre/post intervention (up to 6 months)
|
Obsessive-Compulsive Inventory-Revised (patient)
Time Frame: Pre/post intervention (up to 6 months)
|
Questionnaire evaluating patient obsessionality.
Eighteen items are rated 0-4, with higher scores indicating higher obsessionality.
|
Pre/post intervention (up to 6 months)
|
Provider adaptation of the Eating Disorder Examination-Questionnaire (provider)
Time Frame: Pre/post intervention (up to 6 months)
|
Provider impression of patient eating disorder symptoms will also be assessed at baseline and end of treatment using a version of the Eating Disorder Examination Questionnaire modified for provider-report.
The self-report measure includes items rated 1-6.
It has 4 subscales (including dietary restriction, weight concern, shape concern, and eating concern) and a global score.
Higher scores on each scale indicate more severe eating disorder symptomology
|
Pre/post intervention (up to 6 months)
|
Illness Perception Questionnaire (caregiver)
Time Frame: Pre/post intervention (up to 6 months)
|
Caregiver beliefs and perceptions about their child's illness will be assessed using this measure.
Items are rated 0-10.
A higher score reflects a more threatening view of the illness.
|
Pre/post intervention (up to 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jocelyn Lebow, PhD, LP, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-011880
- 1R34MH128296-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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