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Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139462
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
James Dale Lock, Stanford University

Brief Summary:
This study will use a data base of archived therapy sessions of family therapy for adolescent anorexia nervosa to determine the role of fidelity to treatment and outcome. In addition, it will develop a novel, more efficient way to train therapists in family therapy for adolescent anorexia nervosa and examine if it is feasible to conduct a trial comparing this novel training to standard, more intensive training.

Condition or disease Intervention/treatment Phase
Online Training for Therapists Other: Standard FBT training Other: Novel FBT training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
Study Start Date : May 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Standard training
Therapists will receive standard training in FBT.
Other: Standard FBT training
Therapists will receive standard training in Family Based Treatment (FBT)

Experimental: Novel training
Therapists will receive a novel, more efficient training in FBT
Other: Novel FBT training
Therapists will receive a novel training in Family Based Treatment (FBT)




Primary Outcome Measures :
  1. Feasibility [ Time Frame: end of treatment (approximately 1.5 years after beginning training) ]
    The primary outcome will be feasibility (e.g., recruitment, attrition, assessment battery, resource costs) to conduct a sufficiently powered comparative study.


Secondary Outcome Measures :
  1. Fidelity [ Time Frame: Session 4, end of training (approximately 1.5 years after beginning training) ]
    Secondary outcomes include exploring differences in therapist fidelity and relationships between fidelity and patient outcomes between these two groups (e.g., fidelity and weight change at session 4).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • masters or doctoral training in their field (psychology, psychiatry, family therapy).
  • must be licensed
  • have no reports of malpractice or loss of privileges at clinical institution
  • minimum caseload 5 adolescents with AN each year over past 3 years
  • no previous training in FBT
  • computer/web access

Exclusion Criteria:

  • Previous FBT training for AN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139462


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: James Lock, MD, PhD Stanford University
Principal Investigator: Daniel Le Grange, PhD University of California, San Francisco
Principal Investigator: W. Stewart Agras, MD Stanford University

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Responsible Party: James Dale Lock, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02139462    
Other Study ID Numbers: 1R21MH096779-01 ( U.S. NIH Grant/Contract )
SPO 103420 ( Other Grant/Funding Number: NIH )
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Keywords provided by James Dale Lock, Stanford University:
FBT, fidelity, training
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders