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RECRUITINGINTERVENTIONAL

Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants are 12-18 years of age 2. Participants live with a family (some families may contain only one parent) 3. Family members fluently speak and read English and have access to a computer with internet 4. Participants meet DSM-5 criteria for AN (both subtypes) 5. EBW above 75% 6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine 7. Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study. 8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking. Who Should NOT Join This Trial: Current psychotic illness or intellectual disability or 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; and inability of the participant and/or family to speak and understand English. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participants are 12-18 years of age 2. Participants live with a family (some families may contain only one parent) 3. Family members fluently speak and read English and have access to a computer with internet 4. Participants meet DSM-5 criteria for AN (both subtypes) 5. EBW above 75% 6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine 7. Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study. 8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking. Exclusion Criteria: Current psychotic illness or intellectual disability or 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; and inability of the participant and/or family to speak and understand English.

Treatments Being Tested

BEHAVIORAL

Online Guided Self-Help-Family-based Treatment

GSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an introduction orienting the viewer to the videos, 5-9 short videos (\< 7 minutes each), and assigned reading from the parent education manual Help Your Teenager Beat an Eating Disorder. Three lectures include additional resources for parents (e.g., Academy of Eating Disorder (AED) Medical Management Guidelines). Homework assignments are included with some lectures (e.g., strategies to help the child eat during meals, practice making calorically dense meals). In line with GSH approaches, coach-therapists direct parents, to watch or re-watch specific video content contained in the online learning material related to their questions rather than direct behavioral change.

BEHAVIORAL

FBT via Videoconferencing

15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family.

Locations (2)

Stanford University
Stanford, California, United States
McMaster University
Hamilton, Ontario, Canada