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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH077856 | U.S. NIH Grant/Contract | View source | |
| 5R34MH077856 | U.S. NIH Grant/Contract | View source | |
| DSIR 84-CTS |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will test a family-based therapy aimed at preventing or reducing the symptoms of bipolar disorder in at-risk children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-focused therapy | Experimental | Participants will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-focused therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 every 4 months for 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed onset of first manic, mixed, or hypomanic episode, measured on the A-LIFE | Measured every 4 months for 1 year | |
| Scores on the Child Depression Rating Scale | Measured every 4 months for 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J. Miklowitz, PhD | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine, Lucile Packard Children's Hospital | Stanford | California | 94304 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18606036 | Background | 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. | |
| 17347355 | Background | Chang 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. |
| Label | URL |
|---|---|
| UCLA Child and Adolescent Mood Disorders Program | View source |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005196 | Family Therapy |
| D000083626 | Psychosocial Intervention |
| D011613 | Psychotherapy |
| D001521 | Behavior Therapy |
| D000067498 | Crew Resource Management, Healthcare |
| D059026 | Diagnostic Self Evaluation |
| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| D012960 | Socioenvironmental Therapy |
| D004191 | Behavioral Disciplines and Activities |
| D010346 | Patient Care Management |
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| Brief educational treatment | Behavioral | 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. |
|
|
| Scores on the Young Mania Rating Scale | Measured every 4 months for 1 year |
| Parental mood and distress, as measured by the Beck Depression Inventory, Symptom Checklist | Measured every 4 months for 1 year |
| University of Colorado, Boulder |
| Boulder |
| Colorado |
| 80309-0345 |
| United States |
| 23357439 | Result | 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. |
| 28731778 | Derived | Schneck 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. |
| D006298 | Health Services Administration |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |