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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01280799
Date of registration: 19/01/2011
Primary sponsor: Towson University
Public title: Family Treatment for Adolescents With Anorexia Nervosa
Scientific title: Acceptance Based Separated Family Treatment for Adolescents With Anorexia Nervosa
Date of first enrolment: May 2009
Target sample size: 22
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01280799
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Contacts
Name:   Alix Timko, PhD
Address: 
Telephone: 215-596-7182
Email: a.timko@usp.edu
Affiliation: 
Name:   Alix Timko, PhD
Address: 
Telephone:
Email:
Affiliation:  Towson University/University of the Sciences
Key inclusion & exclusion criteria

Inclusion Criteria:

- Adolescent is between 12-18 years of age and living in home with caregivers

- Parent or primary caregiver willing to attend therapy sessions

- Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or
binge/purge subtype) or subthreshold AN (relaxation of weight criterion to 90% of
ideal body weight as determined by weight history and CDC growth curves) or eating
disorder not otherwise specified (with restricting as the primary symptom) according
to the DSM-IV TR

- Adolescent is appropriate for outpatient care and receives medical clearance from a
primary care physician

Exclusion Criteria:

- Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, bi-polar
disorder, or substance dependence

- Caregiver or adolescent with diagnosis of mental retardation or a pervasive
developmental disorder

- Adolescent with a diagnosis of eating disorder not otherwise specified with the
primary symptoms of bingeing and purging, binging without compensatory behaviors or
spitting food or with restricting patterns but a BMI greater than 90% ideal weight
(as determined by weight history and CDC growth curves)

- Adolescent with extreme malnutrition or other medical complications/ diagnoses that
require a higher level of care

- Acute suicide risk



Age minimum: 12 Years
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Anorexia Nervosa
Eating Disorder Not Otherwise Specified, Primarily Restriction
Subthreshold Anorexia Nervosa
Intervention(s)
Behavioral: Acceptance-based separated family treatment
Primary Outcome(s)
Body Mass Index (BMI [Time Frame: 9 months (6 months active treatment, 3 months follow-up)]
Secondary Outcome(s)
Eating Disorder Examination (16.0D) [Time Frame: 9 months (6 months of treatment and 3 month follow-up)]
Secondary ID(s)
R21MH08597
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Duke University
University of the Sciences in Philadelphia
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