Bipolar DisorderNCT00943085
Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder
A study testing Family-focused therapy and Brief educational treatment in people with Bipolar Disorder, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Family-focused therapy and Brief educational treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Aug 2011
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has at least one biological parent or stepparent with whom the child or adolescent participant lives and who is willing to participate in family treatment
- Has a DSM-IV diagnosis of at least one of the following within the past 2 years : bipolar disorder not otherwise specified (BD-NOS), major depressive disorder (MDD), or cyclothymia
- If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
- Has evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks
- Not currently enrolled in family or marital therapy
- Has at least one biological parent or sibling with a verifiable diagnosis of bipolar disorder I or II
- Speaks English
Who cannot join
- Fully diagnosable bipolar disorder I or II
- Diagnosis of autism or pervasive developmental disorder
- Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70
- Presence of comorbid neurologic diseases such as seizure disorder
- Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment
- Evidence of a life-threatening eating disorder or other medical disorder that requires emergency medical treatment
- Has previously been treated with family-focused therapy
- Evidence of current sexual or physical abuse or domestic abuse between the adult partners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado, Boulder
Boulder, Colorado, 80309-0345
Stanford University School of Medicine, Lucile Packard Children's Hospital
Stanford, California, 94304
About this study
Official title: Family-Focused Therapy as Early Treatment for Youth at Risk for Bipolar Disorder
This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.
Read the detailed description
Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age 18. In addition to the debilitating effects of BD, which include episodes of lethargic depression and exhausting mania, children and adolescents with BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders. Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which targets children and adolescents who are at risk for developing BD. FFT will include education about BD and training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to prevent expression of BD, delay the onset or reduce the severity of manic episodes, and ensure that the first treatment received is appropriate.
Participation in this study will last 1 year and include three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will also provide information on the family background of mood or anxiety problems. In the second part, participants will be randomly assigned to receive one of two treatments: FFT or brief educational treatment. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving brief educational treatment will complete diagnostic assessments and a 1-hour individualized feedback session, and they will be given a workbook about childhood mood disorders. A counselor will be available to all participants, in case of emergencies, for the full study year. All participants will also be provided with standard pharmacotherapy as needed. In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study.
- Conditions
- Bipolar Disorder
- Being tested
- Family-focused therapy, Brief educational treatment
- Keywords
- Early Signs of Bipolar Disorder, High Risk Youth, Adolescence, Childhood
- 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 therapyBehavioural
Also called FFT, Family Therapy, Psychoeducation, Psychosocial Intervention
12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. Ongoing medication management from a study psychiatrist will be available.
Brief educational treatmentBehavioural
Also called Psychoeducation, Crisis Management, Enhanced Care, Diagnostic Evaluation
Thorough diagnostic assessment by a study evaluator, separate evaluation by a child psychiatrist, feedback session with parents and child, and provision of reading materials pertinent to managing childhood mood disorders. Ongoing medication management and crisis-oriented family sessions will be available as needed.
| Study group | Role | What they receive |
|---|---|---|
| Family-focused therapy | Experimental | Participants will receive family-focused therapy. Receives: Behavioral: Family-focused therapy |
| Brief educational treatment | Active comparator | Participants will receive one session of diagnostic feedback, recommendations for continued treatment, and crisis intervention as needed. Receives: Behavioral: Brief educational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in symptoms and functioning of at-risk children, as defined by depression and mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
Measured: Measured every 4 months for 1 year
Secondary outcomes (4)
Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE
Measured: Measured every 4 months for 1 year
Scores on the Child Depression Rating Scale
Measured: Measured every 4 months for 1 year
Scores on the Young Mania Rating Scale
Measured: Measured every 4 months for 1 year
Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist
Measured: Measured every 4 months for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionAug 2011
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- David J. Miklowitz, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943085
- Sponsor's protocol ID
- R34MH077856
- Other IDs
- R34MH077856, 5R34MH077856, DSIR 84-CTS
- Status last verified
- Mar 2014
- First submitted
- 20 Jul 2009
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Miklowitz DJ, Chang KD. Prevention of bipolar disorder in at-risk children: theoretical assumptions and empirical foundations. Dev Psychopathol. 2008 Summer;20(3):881-97. doi: 10.1017/S0954579408000424.
PubMed 18606036Chang K, Howe M, Gallelli K, Miklowitz D. Prevention of pediatric bipolar disorder: integration of neurobiological and psychosocial processes. Ann N Y Acad Sci. 2006 Dec;1094:235-47. doi: 10.1196/annals.1376.026.
PubMed 17347355Miklowitz 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 23357439Schneck CD, Chang KD, Singh MK, DelBello MP, Miklowitz DJ. A Pharmacologic Algorithm for Youth Who Are at High Risk for Bipolar Disorder. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):796-805. doi: 10.1089/cap.2017.0035. Epub 2017 Jul 21.
PubMed 28731778
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 Therapy as Early Treatment for Youth at Risk for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00943085
- Acronym / sponsor ID
- R34MH077856
- Conditions
- Bipolar Disorder
- Keywords
- Early Signs of Bipolar Disorder, High Risk Youth, Adolescence, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Jul 2009 (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 test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.
Detailed description
Early-onset bipolar disorder (BD) is a chronic, recurrent disorder that starts before age 18. In addition to the debilitating effects of BD, which include episodes of lethargic depression and exhausting mania, children and adolescents with BD often have co-occurring disorders, such as attention deficit hyperactivity disorder, conduct disorder, substance abuse disorders, and anxiety disorders. Early interventions may lead to better mental health by preventing BD from ever fully expressing itself. This study will test an early intervention for BD called family-focused treatment (FFT), which targets children and adolescents who are at risk for developing BD. FFT will include education about BD and training in communication strategies and problem-solving skills. It will focus on the family, because family environmental factors are related to the course and recurrence of BD. By reducing risk factors and teaching coping skills, FFT aims to prevent expression of BD, delay the onset or reduce the severity of manic episodes, and ensure that the first treatment received is appropriate.
Participation in this study will last 1 year and include three parts. In the first part, participating children and their families will complete research interviews and questionnaires about the child's mood, behavior, beliefs, and problems. Parent participants will also provide information on the family background of mood or anxiety problems. In the second part, participants will be randomly assigned to receive one of two treatments: FFT or brief educational treatment. Participants receiving FFT will complete 12 therapy sessions in which parents, children, and siblings learn how to cope with mood disorders, new ways to talk to each other, and strategies for solving family problems. FFT sessions will occur weekly for the first 8 weeks and then every other week for the next 8 weeks. Participants receiving brief educational treatment will complete diagnostic assessments and a 1-hour individualized feedback session, and they will be given a workbook about childhood mood disorders. A counselor will be available to all participants, in case of emergencies, for the full study year. All participants will also be provided with standard pharmacotherapy as needed. In the third part of the study, participants will complete follow-up assessments every 4 months for 1 year. Assessments will include interviews and questionnaires similar to those completed in the first part of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-focused therapy | Experimental | Behavioral: Family-focused therapyParticipants will receive family-focused therapy. |
| Brief educational treatment | Active comparator | Behavioral: Brief educational treatmentParticipants will receive one session of diagnostic feedback, recommendations for continued treatment, and crisis intervention as needed. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Has at least one biological parent or stepparent with whom the child or adolescent participant lives and who is willing to participate in family treatment
- Has a DSM-IV diagnosis of at least one of the following within the past 2 years : bipolar disorder not otherwise specified (BD-NOS), major depressive disorder (MDD), or cyclothymia
- If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
- Has evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks
- Not currently enrolled in family or marital therapy
Key exclusion criteria (8 listed)
- Fully diagnosable bipolar disorder I or II
- Diagnosis of autism or pervasive developmental disorder
- Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70
- Presence of comorbid neurologic diseases such as seizure disorder
- Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment
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 therapyAlso: FFT, Family Therapy, Psychoeducation, Psychosocial Intervention12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. Ongoing medication management from a study psychiatrist will be available. | Behavioural | Family-focused therapy |
| Brief educational treatmentAlso: Psychoeducation, Crisis Management, Enhanced Care, Diagnostic EvaluationThorough diagnostic assessment by a study evaluator, separate evaluation by a child psychiatrist, feedback session with parents and child, and provision of reading materials pertinent to managing childhood mood disorders. Ongoing medication management and crisis-oriented family sessions will be available as needed. | Behavioural | Brief educational treatment |
Primary outcome
Changes in symptoms and functioning of at-risk children, as defined by depression and mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)
Time frame: Measured every 4 months for 1 year
4 secondary outcomes
Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE
Time frame: Measured every 4 months for 1 year
Scores on the Child Depression Rating Scale
Time frame: Measured every 4 months for 1 year
Scores on the Young Mania Rating Scale
Time frame: Measured every 4 months for 1 year
Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist
Time frame: Measured every 4 months for 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 26 Mar 2014.
- Background: PubMed 18606036Miklowitz DJ, Chang KD. Prevention of bipolar disorder in at-risk children: theoretical assumptions and empirical foundations. Dev Psychopathol. 2008 Summer;20(3):881-97. doi: 10.1017/S0954579408000424.
- Background: PubMed 17347355Chang K, Howe M, Gallelli K, Miklowitz D. Prevention of pediatric bipolar disorder: integration of neurobiological and psychosocial processes. Ann N Y Acad Sci. 2006 Dec;1094:235-47. doi: 10.1196/annals.1376.026.
- Results publication: 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 28731778Schneck CD, Chang KD, Singh MK, DelBello MP, Miklowitz DJ. A Pharmacologic Algorithm for Youth Who Are at High Risk for Bipolar Disorder. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):796-805. doi: 10.1089/cap.2017.0035. Epub 2017 Jul 21.
- 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, PhD principal investigator
University of Colorado, Boulder
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-focused therapy and Brief educational treatment 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 7 inclusion and 8 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.
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?
Changes in symptoms and functioning of at-risk children, as defined by depression and mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE) (time frame: Measured every 4 months for 1 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 NCT00943085, 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.