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Parenting in 2 Worlds Multisite Trial

Study acronym: (P2W)
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 75% 1440 → 360 participants
See other at-risk trials from Arizona State University

Record History

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  1. Enrollment reduced: 1440 → 360 participantsv6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: May 31, 2026 to May 1, 2027
    • Study completion date: Jun 30, 2027 to Jun 1, 2028
    v4
  4. Primary completion date: May 2026 to May 31, 2026
    • Study completion date: Jun 2027 to Jun 30, 2027
    v3
  5. Primary endpoints: 14 to 15
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06324318
Lead Sponsor Arizona State University
Collaborators: Phoenix Indian Center, Ain Dah Yung Center, Denver Indian Center Inc, Native American Community Services of Erie and Niagara Counties, National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Parenting, Mental Health Wellness 1, Substance Use, Risky Health Behavior
Related terms Health Risk Behaviors, Substance-Related Disorders
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov