Mood DisordersPhase 2FFTNCT02097563
Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
A Phase 2 study testing High Intensity Training and Low Intensity Training in people with Mood Disorders and Psychotic Disorders, run by University of California, Los Angeles at 3 sites in United States.
Trial summary
The present study aims to : 1. compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT); 2. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Mood Disorders, Psychotic Disorders
- What is being tested?
- High Intensity Training and Low Intensity Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2014to 1 Jan 2019
- Phase
- Phase 2
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For patient participants:
- Youth (13-17 years of age) and young adults (18-25 years of age) with the following:
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar disorder (BD) type I or II;
- DSM-5 diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified [NOS];
- DSM-5 diagnosis of bipolar disorder, not elsewhere classified (formerly bipolar NOS; see criteria below); or
- Research classification of ultra high-risk for psychosis.
Show all 11Show fewer
- at least one parent or step-parent with whom the subject lives is willing to participate in family treatment sessions;
- the potential patient and relative(s) participants are able and willing to give written informed assent/consent to participate in the study.
- works at one of the participating agencies (Harbor/UCLA, San Fernando Mental Health Center, Didi Hirsch Mental Health Services)
- provides mental health care for youth or young adults with (or at risk for) bipolar or psychotic disorders
- are licensed (medical, psychologist, clinical social work, marriage and family therapy) mental health provider or are eligible to be a licensed mental health provider (social work / psychology intern or extern, psychiatry resident, psychiatry child and adolescent psychiatry fellow) in the State of California working under the direct supervision of a licensed mental health professional.
Who cannot join
- a DSM-5 diagnosis of autism or pervasive developmental disorder, by history or medical records;
- evidence of mental retardation by history or medical records (IQ < 70);
- diagnosable and active substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least 4 months;
- a life-threatening medical disorder that requires immediate hospitalization or other emergency treatment;
- evidence of current sexual or physical abuse of the child, and/or current domestic abuse between the adult partners. These situations usually require notification of the Department of Child Services and forms of treatment other than family therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Didi Hirsch Mental Health Services
Culver City, California, 90230
San Fernando Mental Health Center
Granada Hills, California, 91344
Harbor/UCLA Outpatient Psychiatry Porgram
Torrance, California, 90502
About this study
The present study aims to :
- compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT);
- assess the cost of FFT training and implementation support; and
- determine whether these different forms of clinician training are associated with different outcomes over 1 year among patients with early-onset mood and psychotic disorders.
Read the detailed description
Despite impressive results in laboratory settings, there has been a significant lag in the community adoption and sustainability of family interventions for early-onset mood and psychotic disorders. Our objective is to determine the optimal methods of training and monitoring the delivery of an evidence-based family-focused treatment (FFT) in community providers who treat young patients (ages 13-25) with bipolar disorder (BD), psychosis, or "high-risk" conditions. FFT is administered in 12 sessions of psychoeducation, communication training, and problem-solving skills training. There are six randomized controlled trials indicating that, among adults or adolescents with BD, bipolar spectrum, or psychosis-risk disorders, FFT and pharmacotherapy are associated with more rapid stabilization of symptoms, delayed recurrences, enhanced functioning, better medication adherence, and improvements in family interaction relative to comparison treatments over 1-2 years. Using a community partnered participatory approach, we will engage diverse stakeholders (clinicians, administrators, caregivers) at three community sites (Harbor-UCLA Medical Center, San Fernando Mental Health Center, Didi Hirsch Mental Health Center) that treat early-onset, lower socioeconomic status, urban, and racially and ethnically diverse bipolar and psychosis patients. We will partner with these 3 community sites to randomly assign 30 clinicians to low intensity (web-based training plus low intensity supervision) or high intensity training (live workshop and higher intensity supervision, i.e., weekly individual supervision with fidelity feedback). Clinicians will administer FFT to up to 120 patients (ages 13-25) with recent-onset mania, psychosis or high-risk conditions. We expect that 20 clinicians will complete the treatment with 80 patients. Dependent variables will be empirically-derived fidelity component scores over time as measured by supervisors and clinicians. We hypothesize that after training, clinicians in both the high and low intensity groups will attain minimum levels of fidelity required for certification in the four components. However, clinicians in high intensity training will sustain higher levels of fidelity across subsequent treatment cases, and will be more satisfied and more likely to adopt the FFT model. This study will facilitate the translation of an evidence-based intervention and identify effective treatment components to inform larger-scale dissemination of FFT in community settings.
- Conditions
- Mood Disorders, Psychotic Disorders
- Being tested
- High Intensity Training, Low Intensity Training
- Keywords
- Mood Disorders, Psychosis, Subthreshold, Bipolar Disorder
- Medical subject headings
- Mood Disorders, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity TrainingBehavioural
This is a training method involving a live workshop followed by high intensity technical consultation.
Low Intensity TrainingBehavioural
Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Training | Experimental | High intensity training: clinician attends a 6-hr live workshop in family-focused treatment techniques, and then, after taking on a case, gets weekly technical consultation sessions (by telephone) in FFT from an expert after every session; Receives: Behavioral: High Intensity Training |
| Low Intensity Training | Active comparator | Low Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session. Receives: Behavioral: Low Intensity Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapist Competency and Adherence Rating
This is a measure of how well the clinician administered family-focused treatment (FFT) based on ratings of audiotapes of family intervention sessions. These ratings are made every third session in both training conditions. This is an overall rating that can vary from 1 (nonadherent) to 7 (excellent adherence)
Measured: One year
Secondary outcomes (2)
Patient Health Questionnaire, 9
Self-rating of depression and impairment, administered at baseline, 4 months, and 12 months
Measured: 1 year
Young Mania Rating Scale
Mania symptoms (based on observer report) at baseline, 4 months and 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study start1 Jun 2014
- Primary completionJan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David J Miklowitz, Ph.D., Principal investigator, UCLA Semel InstituteBowen Chung, M.D., Study director, Harbor/UCLA Outpatient Psychiatry ProgramIra Lesser, M.D., Study director, Harbor/UCLA Outpatient Psychiatry Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097563
- Sponsor's protocol ID
- 5R33MH097007
- Acronym
- FFT
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
PubMed 23357439Miklowitz DJ, Weintraub MJ, Posta F, Denenny DM, Chung B. Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. Fam Process. 2021 Sep;60(3):727-740. doi: 10.1111/famp.12646. Epub 2021 Mar 29.
PubMed 33779991
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Therapy for Youth With Early-Onset Bipolar or Psychotic Disorders
- ClinicalTrials.gov ID
- NCT02097563
- Acronym / sponsor ID
- FFT / 5R33MH097007
- Conditions
- Mood Disorders, Psychotic Disorders
- Keywords
- Mood Disorders, Psychosis, Subthreshold, Bipolar Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 27 Mar 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.
The present study aims to :
- compare different approaches (high intensity vs. low intensity) to training community providers (those who routinely treat young patients with bipolar disorder, psychosis, or sub-threshold high-risk conditions) on the implementation of family-focused treatment (FFT);
- assess the cost of FFT training and implementation support; and
- determine whether these different forms of clinician training are associated with different outcomes over 1 year among patients with early-onset mood and psychotic disorders.
Detailed description
Despite impressive results in laboratory settings, there has been a significant lag in the community adoption and sustainability of family interventions for early-onset mood and psychotic disorders. Our objective is to determine the optimal methods of training and monitoring the delivery of an evidence-based family-focused treatment (FFT) in community providers who treat young patients (ages 13-25) with bipolar disorder (BD), psychosis, or "high-risk" conditions. FFT is administered in 12 sessions of psychoeducation, communication training, and problem-solving skills training. There are six randomized controlled trials indicating that, among adults or adolescents with BD, bipolar spectrum, or psychosis-risk disorders, FFT and pharmacotherapy are associated with more rapid stabilization of symptoms, delayed recurrences, enhanced functioning, better medication adherence, and improvements in family interaction relative to comparison treatments over 1-2 years. Using a community partnered participatory approach, we will engage diverse stakeholders (clinicians, administrators, caregivers) at three community sites (Harbor-UCLA Medical Center, San Fernando Mental Health Center, Didi Hirsch Mental Health Center) that treat early-onset, lower socioeconomic status, urban, and racially and ethnically diverse bipolar and psychosis patients. We will partner with these 3 community sites to randomly assign 30 clinicians to low intensity (web-based training plus low intensity supervision) or high intensity training (live workshop and higher intensity supervision, i.e., weekly individual supervision with fidelity feedback). Clinicians will administer FFT to up to 120 patients (ages 13-25) with recent-onset mania, psychosis or high-risk conditions. We expect that 20 clinicians will complete the treatment with 80 patients. Dependent variables will be empirically-derived fidelity component scores over time as measured by supervisors and clinicians. We hypothesize that after training, clinicians in both the high and low intensity groups will attain minimum levels of fidelity required for certification in the four components. However, clinicians in high intensity training will sustain higher levels of fidelity across subsequent treatment cases, and will be more satisfied and more likely to adopt the FFT model. This study will facilitate the translation of an evidence-based intervention and identify effective treatment components to inform larger-scale dissemination of FFT in community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Training | Experimental | Behavioral: High Intensity TrainingHigh intensity training: clinician attends a 6-hr live workshop in family-focused treatment techniques, and then, after taking on a case, gets weekly technical consultation sessions (by telephone) in FFT from an expert after every session; |
| Low Intensity Training | Active comparator | Behavioral: Low Intensity TrainingLow Intensity Training: clinician completes online workshop in FFT and then, after taking on a case, gets telephone consultation sessions after every third session. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of bipolar disorder (BD) type I or II;
- DSM-5 diagnosis of schizophrenia, schizophreniform disorder, or psychosis not otherwise specified [NOS];
- DSM-5 diagnosis of bipolar disorder, not elsewhere classified (formerly bipolar NOS; see criteria below); or
- Research classification of ultra high-risk for psychosis.
- at least one parent or step-parent with whom the subject lives is willing to participate in family treatment sessions;
Key exclusion criteria (5 listed)
- a DSM-5 diagnosis of autism or pervasive developmental disorder, by history or medical records;
- evidence of mental retardation by history or medical records (IQ < 70);
- diagnosable and active substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least 4 months;
- a life-threatening medical disorder that requires immediate hospitalization or other emergency treatment;
- evidence of current sexual or physical abuse of the child, and/or current domestic abuse between the adult partners. These situations usually require notification of the Department of Child Services and forms of treatment other than family therapy.
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 |
|---|---|---|
| High Intensity TrainingThis is a training method involving a live workshop followed by high intensity technical consultation. | Behavioural | High Intensity Training |
| Low Intensity TrainingClinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session. | Behavioural | Low Intensity Training |
Primary outcome
Therapist Competency and Adherence Rating
Time frame: One year
This is a measure of how well the clinician administered family-focused treatment (FFT) based on ratings of audiotapes of family intervention sessions. These ratings are made every third session in both training conditions. This is an overall rating that can vary from 1 (nonadherent) to 7 (excellent adherence)
2 secondary outcomes
Patient Health Questionnaire, 9
Time frame: 1 year
Young Mania Rating Scale
Time frame: 1 year
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 25 Mar 2020.
- Background: PubMed 23357439Miklowitz DJ, Schneck CD, Singh MK, Taylor DO, George EL, Cosgrove VE, Howe ME, Dickinson LM, Garber J, Chang KD. Early intervention for symptomatic youth at risk for bipolar disorder: a randomized trial of family-focused therapy. J Am Acad Child Adolesc Psychiatry. 2013 Feb;52(2):121-31. doi: 10.1016/j.jaac.2012.10.007. Epub 2013 Jan 2.
- Derived from this study: PubMed 33779991Miklowitz DJ, Weintraub MJ, Posta F, Denenny DM, Chung B. Effects of High- versus Low-Intensity Clinician Training on Implementation of Family-Focused Therapy for Youth with Mood and Psychotic Disorders. Fam Process. 2021 Sep;60(3):727-740. doi: 10.1111/famp.12646. Epub 2021 Mar 29.
- UCLA Child and Adolescent Mood Disorders ProgramLink provided by the sponsor.
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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.
David J Miklowitz, Ph.D. principal investigator
UCLA Semel Institute
Bowen Chung, M.D. study director
Harbor/UCLA Outpatient Psychiatry Program
Ira Lesser, M.D. study director
Harbor/UCLA Outpatient Psychiatry Program
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Intensity Training and Low Intensity Training in people with Mood Disorders and Psychotic Disorders, run by University of California, Los Angeles at 3 sites 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 11 inclusion and 5 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Therapist Competency and Adherence Rating (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097563, which also lists 2 linked publications.
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 25 Mar 2020.