Adaptive Treatment for Adolescent Anorexia Nervosa
Primary Purpose
Eating Disorder, Anorexia, Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Treatment
Family Based Treatment + Intensive Parental Coaching
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder focused on measuring anorexia, anorexia nervosa, eating disorder, weight, eating, weight loss, family based treatment, FBT, family treatment, therapy, Maudsley method
Eligibility Criteria
Inclusion Criteria:
- 12-18 years of age and living with participants' families
- meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
- medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
Exclusion Criteria:
- associated physical illness that necessitates hospitalization
- psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
- current dependence on drugs or alcohol
- physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- previous FBT
- currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
- in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.
Sites / Locations
- University of California, San Francisco
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Family Based Treatment
Family Based Treatment + Intensive Parental Coaching
Arm Description
Family Based Treatment of adolescent Anorexia Nervosa
Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.
Outcomes
Primary Outcome Measures
Estimated Body Weight (EBW)
individual with anorexia nervosa's body weight at end of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03097874
First Posted
March 22, 2017
Last Updated
October 5, 2023
Sponsor
Stanford University
Collaborators
University of California, San Francisco, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03097874
Brief Title
Adaptive Treatment for Adolescent Anorexia Nervosa
Official Title
Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, San Francisco, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.
Detailed Description
Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, other bay-area medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively. All assessments and treatments are conducted through tele-health.
At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual.
At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Anorexia, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia Nervosa Restricting Type, Anorexia Nervosa, Atypical, Eating Disorders in Adolescence
Keywords
anorexia, anorexia nervosa, eating disorder, weight, eating, weight loss, family based treatment, FBT, family treatment, therapy, Maudsley method
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Based Treatment
Arm Type
Experimental
Arm Description
Family Based Treatment of adolescent Anorexia Nervosa
Arm Title
Family Based Treatment + Intensive Parental Coaching
Arm Type
Experimental
Arm Description
Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment
Other Intervention Name(s)
Maudsley Method
Intervention Description
Family Based Treatment of adolescent Anorexia Nervosa
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment + Intensive Parental Coaching
Other Intervention Name(s)
FBT + IPC
Intervention Description
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
Primary Outcome Measure Information:
Title
Estimated Body Weight (EBW)
Description
individual with anorexia nervosa's body weight at end of treatment
Time Frame
following 9 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12-18 years of age and living with participants' families
meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
Exclusion Criteria:
associated physical illness that necessitates hospitalization
psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
current dependence on drugs or alcohol
physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
previous FBT
currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5723
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32116856
Citation
L'Insalata A, Trainor C, Bohon C, Mondal S, Le Grange D, Lock J. Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial. Front Psychiatry. 2020 Feb 12;11:41. doi: 10.3389/fpsyt.2020.00041. eCollection 2020.
Results Reference
derived
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Adaptive Treatment for Adolescent Anorexia Nervosa
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