- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
California
-
Los Angeles, California, Verenigde Staten, 90095
- UCLA
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
Andere namen:
|
|
Geen tussenkomst: Usual care group
Usual care control group/No Intervention consists of neither communication of academic information to parents nor invitation to parent support sessions.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in student 30 day alcohol use
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in student 30 day marijuana use
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Mitchell D Wong, MD PhD, University of California, Los Angeles
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB#13-001638
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op LIFT (Parent Information)
-
Dana-Farber Cancer InstituteChildren's Cancer Research FundVoltooidSlapeloosheid | Kinderkanker | Slaap probleemVerenigde Staten
-
ONWARD Medical, Inc.VoltooidChronische dwarslaesieVerenigde Staten, Verenigd Koninkrijk, Canada, Nederland
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHSVoltooidPreventie van tienerzwangerschappen
-
University of FloridaVoltooidBiomechanica | Verschil in lengte van ledematenVerenigde Staten
-
Northwestern UniversityAanmelden op uitnodigingGehoorverlies, BilateraalVerenigde Staten
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...WervingOuderschap | Interventie ouderschapVerenigde Staten
-
Washington University School of MedicineWervingStoppen met roken | Tabak gebruik | Tabak roken | Stoppen met tabaksgebruik | Nicotine verslavingVerenigde Staten
-
Zhen Jun WangPeking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital; The... en andere medewerkersOnbekendAnale fistel | LIFT-stekker | Genezingspercentage | Anale functieChina
-
Rush University Medical CenterBeëindigdRectale fistel | Anale fistel | Fistel in Ano | Transsfincterische fistelVerenigde Staten
-
Penn State UniversityUniversity of South Carolina; Family ConnectionsActief, niet wervend