- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02129153
Linking Families Together Study- A Randomized Trial to Raise Parental Monitoring (LIFT)
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:
- 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.
- 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.
- 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
Status
Intervenção / Tratamento
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:
- 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.
- 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.
- 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
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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 |
|---|---|
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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
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Outros nomes:
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in student 30 day alcohol use
Prazo: baseline, two year, three year (i.e. one year follow up)
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Student self report: During the past 30 days, on how many days did you have at least one drink of alcohol?
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baseline, two year, three year (i.e. one year follow up)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in student 30 day marijuana use
Prazo: baseline, two year, three year (i.e. one year follow up)
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Student self report: During the past 30 days, on how many days did you use marijuana?
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baseline, two year, three year (i.e. one year follow up)
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Change from baseline in parental monitoring
Prazo: baseline, two year, three year (i.e. one year follow up)
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Student completing validated 9-item parental monitoring scale
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baseline, two year, three year (i.e. one year follow up)
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Change from baseline in student standardized test scores
Prazo: baseline, two year, three year (i.e. one year follow up)
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Student standardized test scores
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baseline, two year, three year (i.e. one year follow up)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mitchell D Wong, MD PhD, University of California, Los Angeles
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB#13-001638
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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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Philliber Research & EvaluationThe Office of Adolescent Health, HHSConcluídoPrevenção da Gravidez na Adolescência
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Assuta Hospital SystemsTel Aviv UniversityConcluído
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Sixth Affiliated Hospital, Sun Yat-sen UniversityConcluídoFístula Anal | Cirurgia de fístula analChina
-
Zhen Jun WangPeking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital; The Second Artillery General Hospital e outros colaboradoresDesconhecidoFístula Anal | ELEVADOR | Taxa de Cura | Função analChina
-
Rush University Medical CenterRescindidoFístula Retal | Fístula Anal | Fístula no Ano | Fístula TransesfincterianaEstados Unidos
-
Duke UniversityConcluídoEsgotamento Profissional | Ansiedade | Sintomas Depressivos | Angústia Emocional | Estresse, TrabalhoEstados Unidos
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University of California, San DiegoNational Institute on Drug Abuse (NIDA); Johns Hopkins University; RTI InternationalInscrevendo-se por conviteEstigma Social | HIV (Vírus da Imunodeficiência Humana) | Abuso de Drogas IlícitasQuirguistão
-
IRIS Media IncConcluídoTranstorno do autismoEstados Unidos
-
Florida International UniversityConcluídoTranstorno de Déficit de Atenção e HiperatividadeEstados Unidos