Adaptive Treatment for Adolescent Anorexia Nervosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia

Conditions
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Anorexia, Eating Disorder, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia Nervosa Restricting Type, Anorexia Nervosa, Atypical, Eating Disorders in Adolescence

Intervention / Treatment
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* Behavioral: Family Based Treatment
* Behavioral: Family Based Treatment + Intensive Parental Coaching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Based Treatment<br>Family Based Treatment of adolescent Anorexia Nervosa | Behavioral: Family Based Treatment<br>* Family Based Treatment of adolescent Anorexia Nervosa<br>* Other names: Maudsley Method;|
| Experimental: Family Based Treatment + Intensive Parental Coaching<br>Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4. | Behavioral: Family Based Treatment + Intensive Parental Coaching<br>* Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.<br>* Other names: FBT + IPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Body Weight (EBW) | individual with anorexia nervosa's body weight at end of treatment | following 9 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eating disorder, anorexia, anorexia nervosa, weight, eating, weight loss, family based treatment, FBT, family treatment, therapy, Maudsley method