Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2019-01-01
2022-01-31
Brief Summary
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Detailed Description
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During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up.
Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FBT
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Family Based Treatment
10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.
CBT-E
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Enhanced Cognitive Behavioral Therapy
10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).
Interventions
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Family Based Treatment
10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.
Enhanced Cognitive Behavioral Therapy
10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* is currently living at home
* is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
* if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
* speaks English
* be available for long-term follow-up.
Exclusion Criteria
* psychotic illness/other mental illness requiring hospitalization
* current dependence on drugs or alcohol
* physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* concurrent involvement in other psychological treatment for an eating disorder
* developmental delay that would preclude participation in the intervention.
12 Years
18 Years
ALL
No
Sponsors
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The Miriam Hospital
OTHER
Responsible Party
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Principal Investigators
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Andrea B. Goldschmidt, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Weight Control & Diabetes Research Center
Christina Tortolani, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rhode Island College
Locations
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The Weight Control & Diabetes Research Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1319865
Identifier Type: -
Identifier Source: org_study_id
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