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Early Intervention for Youth at Risk for Bipolar Disorder

26 de setembro de 2021 atualizado por: David J. Miklowitz, Ph.D., University of California, Los Angeles
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.

Visão geral do estudo

Descrição detalhada

Children who are at high risk for developing bipolar disorder (BD) often are showing significant mood swings or depression well before they develop the full disorder. Often, these children have one or more parents who have bipolar disorder. In addition to brief episodes of lethargic depression and mania or hypomania (periods of excessive activity), children and adolescents at risk for 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 has been designed to help children and adolescents who are at risk for developing BD. FFT will combine education about BD with 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 reduce the early symptoms of BD, improve functioning, and delay the onset or reduce the severity of manic episodes.

Participation in this study will last up to 4 years, although the majority of the study will occur in the first year. There are 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 provide information on the family background of mood or anxiety problems. All participants will receive a thorough medical-psychiatric evaluation and be provided with pharmacotherapy (as needed) from a study psychiatrist for the first year of the study.

In the second part, participants will be randomly assigned to receive one of two treatments: FFT or enhanced care. 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 enhanced care will have 3 weekly sessions which will involve the youth and all family members. In session 1, clinicians summarize the diagnostic assessment, introduce mood charting, and offer instructional handouts on managing mood swings. In session 2, clinicians revisit mood charting, discuss medications (if relevant), and help the child and family develop a mood management plan. In session 3, families 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. So, both treatments last 4 months.

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.

The statistical analyses for this study will examine changes in symptoms and functioning from the baseline assessment through the 4 month follow-ups in year 1 and the 6 month follow-ups in years 2-4.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • California
      • Los Angeles, California, Estados Unidos, 90024-1759
        • UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine
      • Stanford, California, Estados Unidos, 94304
        • Stanford University School of Medicine, Lucile Packard Children's Hospital
    • Colorado
      • Boulder, Colorado, Estados Unidos, 80309
        • University of Colorado, Boulder

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

9 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Enhanced Care
Three sessions of family education and three sessions of individual support over 4 months.
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.
Outros nomes:
  • Psicoeducação
  • Gestão de caso
Experimental: Family-Focused Treatment
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.
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.
Outros nomes:
  • Psicoeducação
  • Terapia familiar
  • Psicoeducação Familiar
  • FFT
  • Family Intervention
  • Family Treatment

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in symptom severity
Prazo: Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Delaying onset of a first (hypo)manic or mixed episode
Prazo: 2-4 years
We will evaluate through survival analyses whether family-focused treatment, due to its ameliorative effects on acute symptoms, is superior to enhanced care in delaying onset of a first (hypo)manic or mixed episode during the 2-4 year follow-up.
2-4 years
Psychosocial functioning
Prazo: Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4
Youths in family-focused treatment will show greater improvement from pretreatment to end of a 2-4 year follow-up in psychosocial functioning compared to youth in Enhanced Care.
Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4
Mental health service use
Prazo: Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4
Youth in family-focused treatment will require fewer mental health services from pretreatment to end of a 2-4 year follow-up than youth in enhanced care
Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: David J Miklowitz, PhD, UCLA Department of Psychiatry
  • Investigador principal: Kiki D Chang, MD, Stanford University
  • Investigador principal: Christopher D Schneck, MD, University of Colorado, Denver

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de outubro de 2011

Conclusão Primária (Real)

15 de setembro de 2016

Conclusão do estudo (Real)

15 de setembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

26 de novembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de novembro de 2011

Primeira postagem (Estimativa)

1 de dezembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de setembro de 2021

Última verificação

1 de setembro de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

Upon completing the study we will submit a CD-ROM to the NIH Freedom of Information Act Coordinator containing all raw data, variable coding information, and copies of measures. Prior to archiving the data, we will remove all personal identifiers and other protected information. The youth's and parents' consent forms will make clear that the data, minus any identifying information, will be made available to other researchers at the end of the study.

Prazo de Compartilhamento de IPD

1/01/21-1/01/23

Tipo de informação de suporte de compartilhamento de IPD

  • Protocolo de estudo
  • Plano de Análise Estatística (SAP)
  • Termo de Consentimento Livre e Esclarecido (TCLE)
  • Código Analítico

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Transtorno bipolar

Ensaios clínicos em Enhanced Care

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