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Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

Primary Purpose

Online Training for Therapists

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard FBT training

Novel FBT training

About this trial

This is an interventional health services research trial for Online Training for Therapists focused on measuring FBT, fidelity, training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Standard training

Novel training

Arm Description

Therapists will receive standard training in FBT.

Therapists will receive a novel, more efficient training in FBT

Outcomes

Primary Outcome Measures

Feasibility

The primary outcome will be feasibility (e.g., recruitment, attrition, assessment battery, resource costs) to conduct a sufficiently powered comparative study.

Secondary Outcome Measures

Fidelity

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).

Full Information

NCT ID

NCT02139462

First Posted

May 12, 2014

Last Updated

October 3, 2017

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT02139462

Brief Title

Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

Official Title

Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Online Training for Therapists

Keywords

FBT, fidelity, training

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard training

Arm Type

Experimental

Arm Description

Therapists will receive standard training in FBT.

Arm Title

Novel training

Arm Type

Experimental

Arm Description

Therapists will receive a novel, more efficient training in FBT

Intervention Type

Other

Intervention Name(s)

Standard FBT training

Intervention Description

Therapists will receive standard training in Family Based Treatment (FBT)

Intervention Type

Other

Intervention Name(s)

Novel FBT training

Intervention Description

Therapists will receive a novel training in Family Based Treatment (FBT)

Primary Outcome Measure Information:

Title

Feasibility

Description

The primary outcome will be feasibility (e.g., recruitment, attrition, assessment battery, resource costs) to conduct a sufficiently powered comparative study.

Time Frame

end of treatment (approximately 1.5 years after beginning training)

Secondary Outcome Measure Information:

Title

Fidelity

Description

Time Frame

Session 4, end of training (approximately 1.5 years after beginning training)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Lock, MD, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel Le Grange, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

W. Stewart Agras, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa

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