- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- UCLA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Autres noms:
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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline in student 30 day alcohol use
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline in student 30 day marijuana use
Délai: 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?
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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
Délai: 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
Délai: 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)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mitchell D Wong, MD PhD, University of California, Los Angeles
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB#13-001638
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Essais cliniques sur Abus de substance
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University of BirminghamNewcastle University; National Institute for Health Research, United Kingdom; University of York et autres collaborateursInconnueAbus d'alcool | Abus de drogues
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Children's Mercy Hospital Kansas CityEunice Kennedy Shriver National Institute of Child Health and Human Development... et autres collaborateursComplétéComportement des adolescents | La violence conjugale | Département d'urgence | Abus physique | Abus mental | Abus verbal | Abus Domestique | CŒURÉtats-Unis
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University of ReginaSaskatchewan Health Research Foundation; Saskatchewan Centre for Patient-Oriented... et autres collaborateursActif, ne recrute pas
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University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)ComplétéAbus d'AODÉtats-Unis
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University of ReginaSaskatchewan Health Research Foundation; Saskatchewan Centre for Patient-Oriented...RecrutementAbus d'alcoolCanada
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Capital Medical UniversityRecrutement
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Centers for Disease Control and PreventionThe University of Texas Health Science Center, Houston; University of South... et autres collaborateursComplété
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Stuart WillickSports Medicine Research and Testing Laboratory; Partnership for Clean CompetitionComplétéAbus de drogues sportives | Abus de stéroïdes ou d'hormonesÉtats-Unis
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The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)InconnueDépendance à l'alcool | Dépendance au cannabis | L'abus d'alcool | Abus de cannabis | Abus d'autres substancesÉtats-Unis
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Tzu Chi UniversityRecrutementAbus sur mineurTaïwan
Essais cliniques sur LIFT (Parent Information)
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Dr. Marcia FinlaysonUniversity of Alberta; University of CalgaryComplété
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ONWARD Medical, Inc.ComplétéLésion chronique de la moelle épinièreÉtats-Unis, Royaume-Uni, Canada, Pays-Bas
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Philliber Research & EvaluationThe Office of Adolescent Health, HHSComplétéPrévention de la grossesse chez les adolescentes
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ONWARD Medical, Inc.ComplétéLésion chronique de la moelle épinièreÉtats-Unis
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Zhen Jun WangPeking University Third Hospital; Beijing Luhe Hospital; Beijing Shuyi Hospital et autres collaborateursInconnueFistule anale | Prise LIFT | Taux de guérison | Fonction analeChine
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Assiut UniversityInconnue
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Rush University Medical CenterRésiliéFistule rectale | Fistule anale | Fistule à Ano | Fistule transsphinctérienneÉtats-Unis
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Cairo UniversityInconnue
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University Hospital, GrenobleRoche Diagnostics Meylan France; Assistance Medico-Technique A DomicileComplétéDiabète sucré | Glucose sanguin | Dispositif médical | Systèmes d'information hospitaliersFrance
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Zhen Jun WangPeking University Third Hospital; Shaanxi Provincial People's Hospital; Tianjin... et autres collaborateursInconnueFistule anorectale | Altération de la matrice extracellulaireChine