- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Andre navne:
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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in student 30 day alcohol use
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in student 30 day marijuana use
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mitchell D Wong, MD PhD, University of California, Los Angeles
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB#13-001638
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med LIFT (Parent Information)
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University of California, San FranciscoTilmelding efter invitationAttention Deficit Hyperactivity DisorderForenede Stater
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New York UniversityUkendtOpmærksomhedsunderskud og forstyrrende adfærdsforstyrrelserForenede Stater
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Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Ikke rekrutterer endnuForældreskab | ForældreinterventionForenede Stater
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ONWARD Medical, Inc.AfsluttetKronisk rygmarvsskadeForenede Stater, Det Forenede Kongerige, Canada, Holland
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Philliber Research & EvaluationThe Office of Adolescent Health, HHSAfsluttetForebyggelse af teenagegraviditet
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Zhen Jun WangPeking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital og andre samarbejdspartnereUkendtAnal fistel | LIFT-stik | Helbredelseshastighed | Anal funktionKina
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Duke UniversityAfsluttetUdbrændthed, professionel | Angst | Depressive symptomer | Følelsesmæssig nød | Stress, JobForenede Stater
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ONWARD Medical, Inc.AfsluttetKronisk rygmarvsskadeForenede Stater
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Rush University Medical CenterAfsluttetRektal fistel | Anal fistel | Fistel i Ano | Transsfinkterisk fistelForenede Stater