The goal of this randomized controlled clinical trial is to compare the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders.
Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design.
The main aim is to determine if enhanced cognitive behavior therapy has a similar efficacy as family-based treatment among children and adolescents with eating disorders receiving treatment in an outpatient setting. The main outcome is improvement in eating disorders psychopathology at the end of treatment.
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed eating disorder
Medically stable for outpatient treatment.
Living with at least one of their parents
At least one of their parents could be actively involved in the treatment
Avoidant restrictive food intake disorders
A co-morbid medical condition or disorder known to influence eating or weight, or influence the possibilities to take part in treatment
Psychotic disorders
Acute suicidality
Parallel
Enhanced Cognitive-behavior therapy for adolescents with an eating disorder
BehavioralPsychotherapy
Family-based therapy for adolescents with an eating disorder
BehavioralPsychotherapy
Change in eating disorder psychopathology
Change in global scores on a well-validated semi-structured interview of eating disorder attitudes and behavior, the Eating Disorder Examination - Interview. Possible scores range from 0-6 where higher scores indicate worse symptoms.
Change in eating disorder psychopathology
Change in global and subscale scores on a well-validated self-report questionnaire of eating disorder attitudes and behavior, the Eating Disorder Examination-Questionnaire. Possible scores range from 0-6 where higher scores indicate worse symptoms.
Change in weight (kg) for underweight participants (defined as those participants who are below 18,5 Body Mass Index (BMI) (kg/m2) at baseline or corresponding BMI to age and gender).
Weight gain in kilogram. Higher weight gain means better outcome.
Change in depression
Change in global score on a well-validated self-report questionnaire of depression, the Beck Depression Inventory II. Possible scores range from 0 to 63 where higher scores mean worse symptoms.
Change in anxiety
Change in global score on a well-validated self-report questionnaire of anxiety, the Beck Anxiety Inventory. Possible scores range from 0 to 63 where higher scores mean worse symptoms.
Changes in family function
Change in parent ratings of family functioning measured by the subscale score on a well validated self-report questionnaire- the McMaster Family Assessment Device, General Functioning subscale. Scores on this subscale range from 12 to 48, where higher scores means worse level of family function.
Changes caregiving experience and psychological symptoms
Change in parent ratings on the impact of eating disorder symptoms on caregiving experiences measured by a well validated, self-report measure -the Eating Disorders Symptom Impact Scale. Scores range from 0 to 96, where higher scores mean worse impact of eating disorder symptoms.
Changes caregiving mental health
Change in parent ratings on the mental health symptoms by a well validated, self-report measure -the Hopkins symptoms checklist 25 items. Scores range from 1 to 4 where higher scores mean worse mental health symptoms.
Direct and indirect costs of health care use for patients and parents/caregivers
Register data from the Norwegian Control and Payment of Health Reimbursements Database (KUHR), the Norwegian Patient Registry (NPR), and Social Security Database.
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Oslo University Hospital
Lead sponsor
South-Eastern Norway Regional Health Authority
Collaborator
University of Oslo
Collaborator
Villa Garda Hospital
Collaborator
University of California, San Francisco
Collaborator
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
Haukeland University Hospital
Collaborator
Vestre Viken Hospital Trust
Collaborator
