Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

October 3, 2017 updated by: James Dale Lock, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of treatment (approximately 1.5 years after beginning training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Session 4, end of training (approximately 1.5 years after beginning training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Daniel Le Grange, PhD, University of California, San Francisco
  • Principal Investigator: W. Stewart Agras, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (ESTIMATE)

May 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21MH096779-01 (NIH)
  • SPO 103420 (OTHER_GRANT: NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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