NCT06324318 Parenting in 2 Worlds Multisite Trial
| NCT ID | NCT06324318 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Arizona State University |
| Condition | Parenting |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,440 participants |
| Start Date | 2023-09-14 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,440 participants in total. It began in 2023-09-14 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Adult participants: * Must be American Indian parents or guardians of American Indian children aged 12 to 17 who attend urban schools * Must reside in the service areas of the four urban Indian centers who are participating in this study * Self-identifies as American Indian * Must be primary caregiver responsible for day-to-day decisions for an American Indian child ages 12 to 17 Child Participants: * Aged 12 - 17 * Identified by their parent/guardian as American Indian * Attends an urban school Exclusion Criteria: * Not applicable
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06324318 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Parenting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06324318 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06324318 currently recruiting?
Yes, NCT06324318 is actively recruiting participants. Contact the research team at kulis@asu.edu for enrollment information.
Where is the NCT06324318 trial being conducted?
This trial is being conducted at Phoenix, United States, Denver, United States, Saint Paul, United States, Buffalo, United States.
Who is sponsoring the NCT06324318 clinical trial?
NCT06324318 is sponsored by Arizona State University. The trial plans to enroll 1,440 participants.