Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814653
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-15
First Post:
2023-02-03
Brief Title:
A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluating the Feasibility of a Primary Care-based Treatment for Restrictive Eating Disorders in Children and Adolescents in the Health System
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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 caregivers 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 05 comparable with those found in FBT trials Finally baseline sample characteristics Exploratory Aim will be assessed including caregiver perceptions about their childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34MH128296-01A1 | NIH | None | httpsreporternihgovquickSearch1R34MH128296-01A1 |