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Linking Families Together Study- A Randomized Trial to Raise Parental Monitoring (LIFT)

6 de fevereiro de 2017 atualizado por: Dr. Mitchell Wong, University of California, Los Angeles

In this study, we will evaluate the efficacy and sustainability of the Linking Families Together (LIFT) intervention to improve parental monitoring during the transition from middle to high school a particularly risky time for students' academic performance and health behaviors. This study is based in middle schools around Los Angeles County a region with a high prevalence of teen risky health behaviors.

The aims of our study are:

  1. To conduct a randomized trial of the LIFT intervention and examine whether providing detailed academic information to parents during their child's 7th and 8th grade increases parental monitoring at the end of the two year intervention and one year follow up. We will partner with 3-10 middle schools and recruit 500 student-parent dyads: 250 will be randomized to the intervention arm and 250 to the usual care control group.
  2. To determine whether the LIFT intervention improves students' academic outcomes, as measured by grades, attendance, and standardized test scores at the end of the two year intervention and one year follow up.
  3. To evaluate whether the LIFT intervention lowers rates of adolescent risky health behaviors, specifically substance use (alcohol, marijuana, inhalants, and other drugs) at the end of the two year intervention and one year follow up.

Visão geral do estudo

Descrição detalhada

Despite parental monitoring and school involvement being among the most important protective factors leading to positive teen academic and health trajectories, few theoretically based rigorously evaluated interventions test strategies to support low income parents as their adolescents transition from middle to high school, a particularly risky time for students' academic and health behaviors.

In a successful pilot study, student's missing assignments information was communicated directly to parents. Intervention parents were nearly twice as likely to report their child not telling them enough about his or her school work than control parents. After just 6 months, intervention students had a 0.19 standard deviation increase in GPA over the control group and 0.20 standard deviation higher standardized math test score.

In the proposed study, we will evaluate the efficacy and sustainability of an intervention to improve parental monitoring and thus improve academic outcomes and reduce risky health behaviors. The adapted intervention will also include sessions for parents to build positive parent-child communication and awareness of school expectations.

We propose a randomized controlled trial with 2 arms examining whether providing parents detailed information on their child's academic and behavioral performance in school in combination with basic parenting support, increases parental monitoring for low-income, minority families. We hypothesize that better parental monitoring will lead to improved academic and behavioral performance. Using this design we can determine whether the impact of the information and parenting intervention is also protective of teens engaging in risky health behaviors. We will compare the experimental and control group parents to examine whether providing high-quality academic information to parents of middle school students increases parental monitoring, student academic performance, and teen health outcomes during middle school and beyond.

If the intervention boosts adolescent academic and health outcomes as hypothesized, the results of the proposed study offer schools low-cost strategies to simultaneously positively influence student academic and health trajectories. These findings have the potential to stimulate new research to improve health through innovative interventions to bolster parent teen relationships for gains accrued throughout the life span.

The aims of our study are:

  1. To conduct a randomized trial of the LIFT intervention and examine whether providing detailed academic information to parents during their child's 7th and 8th grade increases parental monitoring at the end of the two year intervention and one year follow up. We will partner with 3-10 middle schools and recruit 500 student-parent dyads: 250 will be randomized to the intervention arm and 250 to the usual care control group.
  2. To determine whether the LIFT intervention improves students' academic outcomes, as measured by grades, attendance, and standardized test scores at the end of the two year intervention and one year follow up.
  3. To evaluate whether the LIFT intervention lowers rates of adolescent risky health behaviors, specifically substance use (alcohol, marijuana, inhalants, and other drugs) at the end of the two year intervention and one year follow up.

Thus the proposed study builds on and extends the earlier pilot study by recruiting more middle schools around Los Angeles, offering parents additional supports through parenting workshops, and assessing the program's impact on adolescent behavioral outcomes. Successfully implementing this study will allow us to demonstrate feasibility for a future randomized controlled trial and assess effect size for parental monitoring and health outcomes.

Tipo de estudo

Intervencional

Inscrição (Real)

318

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, 90095
        • UCLA

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

11 anos a 15 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • For adults, must be a parent/guardian of a student at a participating middle school
  • For minors, must be a student at a participating middle school
  • Must speak English or Spanish
  • Entering 7th grade in Fall 2014 at one of the middle schools participating in the study

Exclusion Criteria:

  • None

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
Experimental: LIFT (Parent information)

LIFT (Parent information): during their child's 7th and 8th grade years research staff will 1. communicate with parents about their child's academic and behavioral performance in school, roughly twice-monthly 2. invite parents to participate in a 2-hour parent support session to help teach parents to communicate better with their child and support better academic and behavioral performance in school

  • students take a baseline survey then 3 surveys (one/year)
  • parents take a baseline survey then 2 surveys (one/year)
  1. Parents will receive specific information about class assignments that the student missed or about poor performance on tests/quizzes. Parents will also be notified about behavioral problems, such as poor attention and class disruption. RA will communicate with parents in Spanish or English by text message, phone, email according to the parents preference for communication
  2. Parents will be invited to parenting seminars to discuss parenting strategies regarding what to do with their child's academic and behavioral information once they receive it from research staff. Sessions will take place at school and last 2 hours. Multiple sessions will be offered throughout the academic year and parents may attend as many sessions as they wish.
Outros nomes:
  • Information/ Linking Families Together (LIFT)
Sem intervenção: Usual care group

Usual care control group/No Intervention consists of neither communication of academic information to parents nor invitation to parent support sessions.

  • students take a baseline survey then 3 surveys (one/year)
  • parents take a baseline survey then 2 surveys (one/year)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in student 30 day alcohol use
Prazo: baseline, two year, three year (i.e. one year follow up)
Student self report: During the past 30 days, on how many days did you have at least one drink of alcohol?
baseline, two year, three year (i.e. one year follow up)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in student 30 day marijuana use
Prazo: baseline, two year, three year (i.e. one year follow up)
Student self report: During the past 30 days, on how many days did you use marijuana?
baseline, two year, three year (i.e. one year follow up)
Change from baseline in parental monitoring
Prazo: baseline, two year, three year (i.e. one year follow up)
Student completing validated 9-item parental monitoring scale
baseline, two year, three year (i.e. one year follow up)
Change from baseline in student standardized test scores
Prazo: baseline, two year, three year (i.e. one year follow up)
Student standardized test scores
baseline, two year, three year (i.e. one year follow up)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Mitchell D Wong, MD PhD, University of California, Los Angeles

Publicações e links úteis

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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

1 de setembro de 2014

Conclusão Primária (Real)

30 de junho de 2016

Conclusão do estudo (Real)

1 de agosto de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de abril de 2014

Primeira postagem (Estimativa)

2 de maio de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

8 de fevereiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de fevereiro de 2017

Última verificação

1 de fevereiro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB#13-001638

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

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 LIFT (Parent Information)

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