Online Training for TherapistsNCT02139462
Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
A study testing Standard FBT training and Novel FBT training in people with Online Training for Therapists, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Online Training for Therapists
- What is being tested?
- Standard FBT training and Novel FBT training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous FBT training for AN
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Online Training for Therapists
- Being tested
- Standard FBT training, Novel FBT training
- Keywords
- FBT, fidelity, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard FBT trainingOther
Therapists will receive standard training in Family Based Treatment (FBT)
Novel FBT trainingOther
Therapists will receive a novel training in Family Based Treatment (FBT)
| Study group | Role | What they receive |
|---|---|---|
| Standard training | Experimental | Therapists will receive standard training in FBT. Receives: Other: Standard FBT training |
| Novel training | Experimental | Therapists will receive a novel, more efficient training in FBT Receives: Other: Novel FBT training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The primary outcome will be feasibility (e.g., recruitment, attrition, assessment battery, resource costs) to conduct a sufficiently powered comparative study.
Measured: end of treatment (approximately 1.5 years after beginning training)
Secondary outcomes (1)
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).
Measured: Session 4, end of training (approximately 1.5 years after beginning training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Online Training for TherapistsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
- Investigators
- James Lock, MD, PhD, Principal investigator, Stanford UniversityDaniel Le Grange, PhD, Principal investigator, University of California, San FranciscoW. Stewart Agras, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139462
- Sponsor's protocol ID
- 1R21MH096779-01
- Other IDs
- SPO 103420
- Status last verified
- Oct 2017
- First submitted
- 12 May 2014
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Fidelity to Family-Based Treatment for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02139462
- Acronym / sponsor ID
- 1R21MH096779-01
- Conditions
- Online Training for Therapists
- Keywords
- FBT, fidelity, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard training | Experimental | Other: Standard FBT trainingTherapists will receive standard training in FBT. |
| Novel training | Experimental | Other: Novel FBT trainingTherapists will receive a novel, more efficient training in FBT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Previous FBT training for AN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard FBT trainingTherapists will receive standard training in Family Based Treatment (FBT) | Other | Standard training |
| Novel FBT trainingTherapists will receive a novel training in Family Based Treatment (FBT) | Other | Novel training |
Primary outcome
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.
1 secondary outcome
Fidelity
Time frame: Session 4, end of training (approximately 1.5 years after beginning training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Lock, MD, PhD principal investigator
Stanford University
Daniel Le Grange, PhD principal investigator
University of California, San Francisco
W. Stewart Agras, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard FBT training and Novel FBT training in people with Online Training for Therapists, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: end of treatment (approximately 1.5 years after beginning training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.