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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01280799 |
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Date of registration:
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19/01/2011 |
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Primary sponsor: |
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Public title:
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Family Treatment for Adolescents With Anorexia Nervosa
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Scientific title:
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Acceptance Based Separated Family Treatment for Adolescents With Anorexia Nervosa |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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22 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01280799 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alix Timko, PhD |
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Address:
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Telephone:
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215-596-7182 |
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Email:
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a.timko@usp.edu |
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Affiliation:
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Name:
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Alix Timko, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Towson University/University of the Sciences |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Anorexia Nervosa
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Eating Disorder Not Otherwise Specified, Primarily Restriction
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Subthreshold Anorexia Nervosa
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Intervention(s)
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Behavioral: Acceptance-based separated family treatment
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Primary Outcome(s)
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Body Mass Index (BMI
[Time Frame: 9 months (6 months active treatment, 3 months follow-up)]
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Secondary Outcome(s)
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Eating Disorder Examination (16.0D)
[Time Frame: 9 months (6 months of treatment and 3 month follow-up)]
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Secondary ID(s)
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R21MH08597
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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