Adaptive Family Treatment for Adolescent Anorexia Nervosa
2 other identifiers
interventional
90
1 country
2
Brief Summary
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 13, 2016
April 1, 2016
4.3 years
April 5, 2012
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Full remission from AN (%MBW>95)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
End of Treatment (6 months)
Secondary Outcomes (1)
Changes in subscale scores of the EDE
End of Treatment (6 months)
Study Arms (2)
Psychotherapy
EXPERIMENTALFamily-Based Therapy (12 sessions)
Family-Based Therapy with Intensive Family-Focused Treatment
EXPERIMENTALThe patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT).
Interventions
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for anorexia nervosa
- Lives with at least one English-speaking parent who is willing to participate
- Medically Stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
You may not qualify if:
- Previous FBT for AN
- Medical condition that may affect eating or weight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- University of Chicagocollaborator
Study Sites (2)
Stanford University
Stanford, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D Lock, MD, PhD
Stanford University
- PRINCIPAL INVESTIGATOR
Daniel LeGrange, PhD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 18, 2012
Study Start
September 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 13, 2016
Record last verified: 2016-04