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Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

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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

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date October 5, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
Official Title  ICMJE Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Online Training for Therapists
Intervention  ICMJE
  • Other: Standard FBT training
    Therapists will receive standard training in Family Based Treatment (FBT)
  • Other: Novel FBT training
    Therapists will receive a novel training in Family Based Treatment (FBT)
Study Arms  ICMJE
  • Experimental: Standard training
    Therapists will receive standard training in FBT.
    Intervention: Other: Standard FBT training
  • Experimental: Novel training
    Therapists will receive a novel, more efficient training in FBT
    Intervention: Other: Novel FBT training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
30
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139462
Other Study ID Numbers  ICMJE 1R21MH096779-01( U.S. NIH Grant/Contract )
SPO 103420 ( Other Grant/Funding Number: NIH )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Dale Lock, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
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
PRS Account Stanford University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP