An interventional study of Family Based Treatment and Family Based Treatment + Intensive Parental Coaching in Eating Disorder, Anorexia and Anorexia Nervosa, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 130 is above the median of 41 across 287 interventional studies indexed under Anorexia.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
Family Based Treatment of adolescent Anorexia Nervosa
Behavioral: Family Based Treatment
Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.
Behavioral: Family Based Treatment + Intensive Parental Coaching
Family Based Treatment of adolescent Anorexia Nervosa
Also known as: Maudsley Method
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
Also known as: FBT + IPC
Estimated Body Weight (EBW)
individual with anorexia nervosa's body weight at end of treatment
Time frame: following 9 months of treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Stanford University