Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

• ClinicalTrials.gov Identifier: NCT02139462
• Recruitment Status: Completed
• First Posted: May 15, 2014
• Last Update Posted: October 5, 2017
• Sponsor: Stanford University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): James Dale Lock, Stanford University

Tracking Information

• First Submitted Date: May 12, 2014
• First Posted Date: May 15, 2014
• Last Update Posted Date: October 5, 2017
• Study Start Date: May 2015
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Online Training for Therapists

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 10, 2016): 47
• Original Estimated Enrollment (submitted: May 13, 2014): 30
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02139462
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: James Dale Lock, Stanford University
• Study Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)

Investigators

• 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