Bipolar DisorderPhase 1/2NCT00571402
Evaluating the Effectiveness of Family-Focused Psychoeducation in Treating Adolescents With Bipolar Disorder
A Phase 1/2 study testing Family-focused therapy for adolescents and Enhanced care in people with Bipolar Disorder, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of family-focused psychoeducational treatment along with medication in treating adolescents with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Family-focused therapy for adolescents and Enhanced care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2001to Sep 2005
- Phase
- Phase 1/2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV criteria for bipolar I, bipolar II, or not otherwise specified (NOS) disorder based on independent Kiddie Schedule for Affective Disorders and Schizophrenia and on present and lifetime version interviews with the patient and at least one parent
- Concurrent physician diagnosis of bipolar I, II, or NOS disorder based on a separate set of evaluations of the parent and child
- At least a 1-week episode of manic, mixed, or hypomanic symptoms or a 2-week episode of depressive symptoms within the 3 months prior to study entry
- Currently taking or willing to proceed with regular pharmacotherapy from a study psychiatrist
- At least one biological parent or step-parent with whom the patient lives who is willing to participate in treatment
Who cannot join
- History of severe, unremitting psychosis lasting more than 3 months
- Evidence of mental retardation (IQ less than 70), organic central nervous system (CNS) disorder, or pervasive developmental disorder
- Substance or alcohol dependence or abuse disorders in the 3 months prior to study entry
- Current life-threatening eating disorder or medical disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Psychology, University of Colorado
Boulder, Colorado, 80309-0345
Child and Adolescent Bipolar Services Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Family-Focused Psychoeducation for Bipolar Adolescents
This study will evaluate the effectiveness of family-focused psychoeducational treatment along with medication in treating adolescents with bipolar I disorder.
Read the detailed description
Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes dramatic changes in a person's mood and energy. People with bipolar disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Early onset of bipolar disorder poses an especially high health risk to affected individuals. For example, adolescents with bipolar I disorder are at increased risk for hospitalizations, social and academic deterioration, suicide, substance abuse, and nonadherence to medications. Treatment-based research for bipolar adolescents has lagged behind research for adults, particularly in the psychosocial arena. Family-focused treatment (FFT), consisting of psychoeducation about bipolar disorder for the patient and relatives, communication enhancement training, and problem-solving training, has shown promise as an effective psychosocial model. In two previous studies, FFT was found to be a useful addition to bipolar medications in treating adult bipolar I disorder. This study will test the effectiveness of FFT that is centered upon the developmental needs of adolescents with bipolar I disorder.
This study will be divided into three phases. In Phases I and II, adolescent participants and their parents will be enrolled into FFT sessions; the adolescents will also be treated with medications using a clinical management manual. The first two phases will be used to revise and perfect the FFT adolescent (FFT-A) focused manual to be used in the Phase III clinical trial portion of the study.
Participation in Phase III will last about 2 years. All adolescent and parent participants in Phase III will first undergo research interviews. Child-only interviews will last 2 hours and will include questions about mood problems, problems with friends or family members, and substance use history. Parent-only interviews will be conducted in two 1-hour sessions and will include questions about their child's mood and behavioral problems, treatments, and how their child's problems have affected family life. Parent participants will also be asked to assist their child in filling out a questionnaire on mood and behavioral problems and to fill out a questionnaire concerning their own history of problems with mood or anxiety. The last of the initial research interviews will be conducted at the University of Colorado's Psychology Department. Parent and child participants, as well as other relatives, will be asked to talk about problems in family life and ways to solve them. Participants will also be asked to describe pictures from inkblot cards.
Next, participants in Phase III will be divided into 1 of 2 treatment groups: FFT-A plus standard bipolar medication or treatment as usual (TAU) plus standard bipolar medication. There will be a total of 25 FFT sessions over a 2-year period. The sessions will occur weekly for 12 weeks, every other week for the next 12 weeks, every month for 3 more months, and every 3 months for 1 more year. During FFT sessions, parent and adolescent participants will learn about mood disorders and ways to solve family problems. The sessions will be held at the Denver Children's Hospital, the University of Colorado Health Sciences Center's outpatient offices, or the University of Colorado's Psychology Department. Participants receiving TAU will be given an educational workbook on mood disorders and ways to cope with them as a family. TAU participants will attend three 3-hour family counseling sessions to explain the content of the workbook. The sessions will take place at the same locations as the FFT sessions. Child participants in both groups will take their prescribed medications for their bipolar disorder and will continue to see their psychiatrists on a regular basis.
Repeat research interviews will occur every 3 months during the first year of the study and every 6 months during the second year of the study. Questionnaires will be distributed for children and their parents every 6 weeks during the first year of the study and every 3 months during the second year of the study. A questionnaire on the child's functioning in the school setting will also be sent to the child participant's school teacher every 3 months. Outcome assessments will be made at baseline and Months 3, 6, 9, and 12.
- Conditions
- Bipolar Disorder
- Being tested
- Family-focused therapy for adolescents, Enhanced care
- Keywords
- Family Treatment, Pharmacotherapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-focused therapy for adolescentsBehavioural
Also called FFT-A
FFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance.
Enhanced careBehavioural
Also called Treatment as usual (TAU)
Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance.
| Study group | Role | What they receive |
|---|---|---|
| FFT | Experimental | Family-focused therapy (FFT) and pharmacotherapy for adolescents, a 21 session family psychoeducational interventio0n administered with best practice medication treatment Receives: Behavioral: Family-focused therapy for adolescents |
| Echanced Care | Active comparator | Enhanced care (EC) and pharmacotherapy for adolescents Receives: Behavioral: Enhanced care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Longitudinal Interval Follow-up Examination
Measured: Measured at baseline and Months 3, 6, 9, and 12
Secondary outcomes (2)
Kiddie Schedule for Affective Disorders and Schizophrenia
Measured: Measured at baseline and Months 3, 6, 9, and 12
Depression and Mania Rating Scales
Measured: Measured at baseline and Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startJul 2001
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David J. Miklowitz, PhD, Principal investigator, University of Colorado at BoulderDavid A. Axelson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571402
- Sponsor's protocol ID
- R21MH062555
- Other IDs
- R21MH062555, DSIR CT-S
- Status last verified
- Mar 2014
- First submitted
- 11 Dec 2007
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miklowitz DJ, George EL, Axelson DA, Kim EY, Birmaher B, Schneck C, Beresford C, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder. J Affect Disord. 2004 Oct;82 Suppl 1(Suppl 1):S113-28. doi: 10.1016/j.jad.2004.05.020.
PubMed 15571785Miklowitz DJ, Biuckians A, Richards JA. Early-onset bipolar disorder: a family treatment perspective. Dev Psychopathol. 2006 Fall;18(4):1247-65. doi: 10.1017/S0954579406060603.
PubMed 17064437Miklowitz DJ, Axelson DA, Birmaher B, George EL, Taylor DO, Schneck CD, Beresford CA, Dickinson LM, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder: results of a 2-year randomized trial. Arch Gen Psychiatry. 2008 Sep;65(9):1053-61. doi: 10.1001/archpsyc.65.9.1053.
PubMed 18762591Miklowitz DJ, Axelson DA, George EL, Taylor DO, Schneck CD, Sullivan AE, Dickinson LM, Birmaher B. Expressed emotion moderates the effects of family-focused treatment for bipolar adolescents. J Am Acad Child Adolesc Psychiatry. 2009 Jun;48(6):643-651. doi: 10.1097/CHI.0b013e3181a0ab9d.
PubMed 19454920
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Psychoeducation for Bipolar Adolescents
- ClinicalTrials.gov ID
- NCT00571402
- Acronym / sponsor ID
- R21MH062555
- Conditions
- Bipolar Disorder
- Keywords
- Family Treatment, Pharmacotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- Jul 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 12 Dec 2007 (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 evaluate the effectiveness of family-focused psychoeducational treatment along with medication in treating adolescents with bipolar I disorder.
Detailed description
Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes dramatic changes in a person's mood and energy. People with bipolar disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Early onset of bipolar disorder poses an especially high health risk to affected individuals. For example, adolescents with bipolar I disorder are at increased risk for hospitalizations, social and academic deterioration, suicide, substance abuse, and nonadherence to medications. Treatment-based research for bipolar adolescents has lagged behind research for adults, particularly in the psychosocial arena. Family-focused treatment (FFT), consisting of psychoeducation about bipolar disorder for the patient and relatives, communication enhancement training, and problem-solving training, has shown promise as an effective psychosocial model. In two previous studies, FFT was found to be a useful addition to bipolar medications in treating adult bipolar I disorder. This study will test the effectiveness of FFT that is centered upon the developmental needs of adolescents with bipolar I disorder.
This study will be divided into three phases. In Phases I and II, adolescent participants and their parents will be enrolled into FFT sessions; the adolescents will also be treated with medications using a clinical management manual. The first two phases will be used to revise and perfect the FFT adolescent (FFT-A) focused manual to be used in the Phase III clinical trial portion of the study.
Participation in Phase III will last about 2 years. All adolescent and parent participants in Phase III will first undergo research interviews. Child-only interviews will last 2 hours and will include questions about mood problems, problems with friends or family members, and substance use history. Parent-only interviews will be conducted in two 1-hour sessions and will include questions about their child's mood and behavioral problems, treatments, and how their child's problems have affected family life. Parent participants will also be asked to assist their child in filling out a questionnaire on mood and behavioral problems and to fill out a questionnaire concerning their own history of problems with mood or anxiety. The last of the initial research interviews will be conducted at the University of Colorado's Psychology Department. Parent and child participants, as well as other relatives, will be asked to talk about problems in family life and ways to solve them. Participants will also be asked to describe pictures from inkblot cards.
Next, participants in Phase III will be divided into 1 of 2 treatment groups: FFT-A plus standard bipolar medication or treatment as usual (TAU) plus standard bipolar medication. There will be a total of 25 FFT sessions over a 2-year period. The sessions will occur weekly for 12 weeks, every other week for the next 12 weeks, every month for 3 more months, and every 3 months for 1 more year. During FFT sessions, parent and adolescent participants will learn about mood disorders and ways to solve family problems. The sessions will be held at the Denver Children's Hospital, the University of Colorado Health Sciences Center's outpatient offices, or the University of Colorado's Psychology Department. Participants receiving TAU will be given an educational workbook on mood disorders and ways to cope with them as a family. TAU participants will attend three 3-hour family counseling sessions to explain the content of the workbook. The sessions will take place at the same locations as the FFT sessions. Child participants in both groups will take their prescribed medications for their bipolar disorder and will continue to see their psychiatrists on a regular basis.
Repeat research interviews will occur every 3 months during the first year of the study and every 6 months during the second year of the study. Questionnaires will be distributed for children and their parents every 6 weeks during the first year of the study and every 3 months during the second year of the study. A questionnaire on the child's functioning in the school setting will also be sent to the child participant's school teacher every 3 months. Outcome assessments will be made at baseline and Months 3, 6, 9, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFT | Experimental | Behavioral: Family-focused therapy for adolescentsFamily-focused therapy (FFT) and pharmacotherapy for adolescents, a 21 session family psychoeducational interventio0n administered with best practice medication treatment |
| Echanced Care | Active comparator | Behavioral: Enhanced careEnhanced care (EC) and pharmacotherapy for adolescents |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for bipolar I, bipolar II, or not otherwise specified (NOS) disorder based on independent Kiddie Schedule for Affective Disorders and Schizophrenia and on present and lifetime version interviews with the patient and at least one parent
- Concurrent physician diagnosis of bipolar I, II, or NOS disorder based on a separate set of evaluations of the parent and child
- At least a 1-week episode of manic, mixed, or hypomanic symptoms or a 2-week episode of depressive symptoms within the 3 months prior to study entry
- Currently taking or willing to proceed with regular pharmacotherapy from a study psychiatrist
- At least one biological parent or step-parent with whom the patient lives who is willing to participate in treatment
Key exclusion criteria (4 listed)
- History of severe, unremitting psychosis lasting more than 3 months
- Evidence of mental retardation (IQ less than 70), organic central nervous system (CNS) disorder, or pervasive developmental disorder
- Substance or alcohol dependence or abuse disorders in the 3 months prior to study entry
- Current life-threatening eating disorder or medical disorder
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 |
|---|---|---|
| Family-focused therapy for adolescentsAlso: FFT-AFFT includes 25 sessions of psychoeducation, communication enhancement training, and problem-solving skills training plus ongoing pharmacological maintenance. | Behavioural | FFT |
| Enhanced careAlso: Treatment as usual (TAU)Enhanced care includes 3 sessions of family psychoeducation plus ongoing pharmacological maintenance. | Behavioural | Echanced Care |
Primary outcome
Adolescent Longitudinal Interval Follow-up Examination
Time frame: Measured at baseline and Months 3, 6, 9, and 12
2 secondary outcomes
Kiddie Schedule for Affective Disorders and Schizophrenia
Time frame: Measured at baseline and Months 3, 6, 9, and 12
Depression and Mania Rating Scales
Time frame: Measured at baseline and Months 3, 6, 9, and 12
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 26 Mar 2014.
- Background: PubMed 15571785Miklowitz DJ, George EL, Axelson DA, Kim EY, Birmaher B, Schneck C, Beresford C, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder. J Affect Disord. 2004 Oct;82 Suppl 1(Suppl 1):S113-28. doi: 10.1016/j.jad.2004.05.020.
- Background: PubMed 17064437Miklowitz DJ, Biuckians A, Richards JA. Early-onset bipolar disorder: a family treatment perspective. Dev Psychopathol. 2006 Fall;18(4):1247-65. doi: 10.1017/S0954579406060603.
- Results publication: PubMed 18762591Miklowitz DJ, Axelson DA, Birmaher B, George EL, Taylor DO, Schneck CD, Beresford CA, Dickinson LM, Craighead WE, Brent DA. Family-focused treatment for adolescents with bipolar disorder: results of a 2-year randomized trial. Arch Gen Psychiatry. 2008 Sep;65(9):1053-61. doi: 10.1001/archpsyc.65.9.1053.
- Results publication: PubMed 19454920Miklowitz DJ, Axelson DA, George EL, Taylor DO, Schneck CD, Sullivan AE, Dickinson LM, Birmaher B. Expressed emotion moderates the effects of family-focused treatment for bipolar adolescents. J Am Acad Child Adolesc Psychiatry. 2009 Jun;48(6):643-651. doi: 10.1097/CHI.0b013e3181a0ab9d.
- Click here for more information on family-focused psychoeducation for bipolar adolescents on the Principal Investigator's Web siteLink 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, PhD principal investigator
University of Colorado at Boulder
David A. Axelson, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Family-focused therapy for adolescents and Enhanced care in people with Bipolar Disorder, run by University of California, Los Angeles at 2 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 5 inclusion and 4 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adolescent Longitudinal Interval Follow-up Examination (time frame: Measured at baseline and Months 3, 6, 9, and 12). 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 NCT00571402, which also lists 4 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 26 Mar 2014.