protocolSection identificationModule nctId: NCT06324318, orgStudyIdInfo id: R01DA056417, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA056417, secondaryIdInfos id: R01DA056417, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA056417, briefTitle: Parenting in 2 Worlds Multisite Trial, acronym: (P2W), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-14, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, collaborators name: Phoenix Indian Center, collaborators name: Ain Dah Yung Center, collaborators name: Denver Indian Center Inc, collaborators name: Native American Community Services of Erie and Niagara Counties, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors., conditionsModule conditions: Parenting, conditions: Mental Health Wellness 1, conditions: Substance Use, conditions: Risky Health Behavior, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: Parenting in 2 Worlds (P2W), interventions name: Healthy Families in 2 Worlds (HF2W), outcomesModule primaryOutcomes measure: Change from baseline in family functioning and cohesion, primaryOutcomes measure: Change from baseline in parental involvement, primaryOutcomes measure: Change from baseline in parental supervision, primaryOutcomes measure: Change from baseline in parental monitoring, primaryOutcomes measure: Change from baseline in positive parenting practices, primaryOutcomes measure: Change from baseline in relational warmth, primaryOutcomes measure: Change from baseline in relational hostility, primaryOutcomes measure: Change from baseline in family conflict, primaryOutcomes measure: Change from baseline in parental self-agency, primaryOutcomes measure: Change from baseline in effective discipline, primaryOutcomes measure: Change from baseline in parental communication about sex, primaryOutcomes measure: Change from baseline in child problem behaviors., primaryOutcomes measure: Change from baseline in decision making about risk behaviors, primaryOutcomes measure: Change from baseline in substance use, primaryOutcomes measure: Change from baseline in risky sexual behaviors, secondaryOutcomes measure: Change from baseline in depressive symptoms, secondaryOutcomes measure: Change from baseline in suicidality, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Phoenix Indian Center, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85012, country: United States, contacts name: Jolyana Begay-Kroupa, role: CONTACT, phone: 602-264-6768, email: jbegay-kroupa@phxindcenter.org, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Denver Indian Center, status: RECRUITING, city: Denver, state: Colorado, zip: 80219, country: United States, contacts name: Rick Waters, role: CONTACT, phone: 303-936-2688, email: rick@denverindiancenter.org, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Ain Dah Yung Center, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55104, country: United States, contacts name: Amy Arndt, role: CONTACT, phone: 651-227-4184, email: amy.arndt@adycenter.org, geoPoint lat: 44.94441, lon: -93.09327, locations facility: Native American Community Services Erie and Niagara Counties, status: RECRUITING, city: Buffalo, state: New York, zip: 14207, country: United States, contacts name: Michael Martin, role: CONTACT, phone: 716-299-0914, email: mmartin@nacswny.org, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False