Early Intervention for Youth at Risk for Bipolar Disorder

NCT01483391 | Completed DMC

• 1 other identifier: R01MH093676
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.

Conditions

Bipolar Disorder; Major Depressive Disorder

Keywords

Bipolar disorder; Major depressive disorder; Mania; Depression; Cyclothymic Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in symptom severity

  Changes in symptoms of at-risk children, as defined by depression and (hypo)mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE, the Child Depression Rating Scale, and the Young Mania Rating Scale

  Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4

Secondary Outcomes (3)

• Delaying onset of a first (hypo)manic or mixed episode

  2-4 years

• Psychosocial functioning

  Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4

• Mental health service use

  Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4

Study Arms (2)

Enhanced Care

ACTIVE COMPARATOR

Three sessions of family education and three sessions of individual support over 4 months.

Behavioral: Enhanced Care

Family-Focused Treatment

EXPERIMENTAL

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.

Behavioral: Family-Focused Treatment

Interventions

Enhanced Care BEHAVIORAL

The 3 family sessions involve the youth and all family members. These sessions will help the child and family members with mood charting and developing a mood management plan. Families will rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan.

Also known as: Psychoeducation, Case Management

Enhanced Care

Family-Focused Treatment 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. The goal of this intervention is to improve the child's ability to regulate moods and to reduce tension and conflict in the family.

Also known as: Family Therapy, Family Psychoeducation, FFT, Family Intervention, Psychoeducation, Family Treatment

Family-Focused Treatment

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For a child to be eligible:
• At least one biological parent or stepparent with whom the child or adolescent lives must be willing to participate in family treatment
• At least one biological parent has a verifiable diagnosis of bipolar disorder I or II
• The child must have a DSM-IV diagnosis of bipolar disorder not otherwise specified or major depressive disorder (MDD)
• If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years
• The child must have 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
• The family must speak English, although English need not be their first language

You may not qualify if:

• 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
• Currently enrolled in regular family therapy
• Evidence of current sexual or physical abuse or domestic abuse between the adult partners

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Stanford University: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (3)

UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine

Los Angeles, California, 90024-1759, United States

Location

Stanford University School of Medicine, Lucile Packard Children's Hospital

Stanford, California, 94304, United States

Location

University of Colorado, Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (6)

• 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.

  PMID: 18606036 BACKGROUND

• Miklowitz DJ, Chang KD, Taylor DO, George EL, Singh MK, Schneck CD, Dickinson LM, Howe ME, Garber J. Early psychosocial intervention for youth at risk for bipolar I or II disorder: a one-year treatment development trial. Bipolar Disord. 2011 Feb;13(1):67-75. doi: 10.1111/j.1399-5618.2011.00890.x.

  PMID: 21320254 BACKGROUND

• Miklowitz DJ, Weintraub MJ, Singh MK, Walshaw PD, Merranko JA, Birmaher B, Chang KD, Schneck CD. Mood Instability in Youth at High Risk for Bipolar Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Oct;61(10):1285-1295. doi: 10.1016/j.jaac.2022.03.009. Epub 2022 Mar 17.

  PMID: 35307538 DERIVED

• Singh MK, Nimarko AF, Garrett AS, Gorelik AJ, Roybal DJ, Walshaw PD, Chang KD, Miklowitz DJ. Changes in Intrinsic Brain Connectivity in Family-Focused Therapy Versus Standard Psychoeducation Among Youths at High Risk for Bipolar Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Apr;60(4):458-469. doi: 10.1016/j.jaac.2020.07.892. Epub 2020 Aug 1.

  PMID: 32745598 DERIVED

• Miklowitz DJ, Schneck CD, Walshaw PD, Singh MK, Sullivan AE, Suddath RL, Forgey Borlik M, Sugar CA, Chang KD. Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):455-463. doi: 10.1001/jamapsychiatry.2019.4520.

  PMID: 31940011 DERIVED

• Miklowitz DJ, Portnoff LC, Armstrong CC, Keenan-Miller D, Breen EC, Muscatell KA, Eisenberger NI, Irwin MR. Inflammatory cytokines and nuclear factor-kappa B activation in adolescents with bipolar and major depressive disorders. Psychiatry Res. 2016 Jul 30;241:315-22. doi: 10.1016/j.psychres.2016.04.120. Epub 2016 May 7.

  PMID: 27227701 DERIVED

Related Links

• UCLA Child and Adolescent Mood Disorders Program
• Stanford University Pediatric Bipolar Disorders Program
• University of Colorado Depression Center

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Mania; Depression; Cyclothymic Disorder

Interventions

Case Management; Family Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David J Miklowitz, PhD

  UCLA Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Kiki D Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Christopher D Schneck, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 26, 2011
• First Posted: December 1, 2011
• Study Start: October 6, 2011
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2020
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 1/01/21-1/01/23

Locations

US (3)