Clinical trial NCT06324318: Parenting in 2 Worlds Multisite Trial
Official title: A Multiregional RCT of Parenting in 2 Worlds for Urban American Indian Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parenting
Mental Health Wellness 1
Substance Use
Risky Health Behavior
Keywords: family functioning
risky sexual behavior
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Phoenix Indian Center
name: Ain Dah Yung Center
name: Denver Indian Center Inc
name: Native American Community Services of Erie and Niagara Counties
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-21
Enrollment: 1440
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The study will conduct a comparative effectiveness trial, with a gender-stratified randomization of adults to alternate interventions in four urban communities. The overall objectives are to test the relative effectiveness of the culturally grounded Parenting in 2 Worlds (P2W) intervention for urban American Indian families in strengthening the proximal outcomes of family functioning and parenting skills, and distal outcomes in preventing adolescent risk behaviors. The investigators will employ Community-based Participatory Research approaches, with the participating urban Indian centers (UICs) partnering with the university research team and each other. Phase 1 has start-up, development, and planning activity, coordinated with a Community Advisory Board, to prepare the UICs to implement the intervention, develop capacity for recruiting, training, and program delivery. This process will integrally involve a UIC that has delivered P2W successfully (Phoenix Indian Center) to share its accumulated capacity-building and implementation expertise. American Indian workshop facilitators from the target communities will receive 2-day trainings on intervention delivery. In Phase 2, each UIC will first implement one cycle/round of the P2W intervention and the comparison group intervention, Healthy Families in 2 Worlds (HF2W) that served as a comparison group in the original Arizona efficacy trial of P2W. A facilitator for P2W and a facilitator for HF2W will each deliver their 10 weekly lessons, on a synchronized schedule. This first cycle will include pretest and post-test data collection and an on-going implementation process review to identify implementation challenges and solutions. After concluding the first cycle, project staff and facilitators from each UIC and the university research team will video conference to review successful implementation strategies and troubleshoot challenges. The UICs will then complete at least 5 additional cycles of delivering P2W and HF2W. For all cycles, each UIC will recruit American Indian parents or guardians of urban American Indian youth (aged 12-17) as workshop participants. Adult participants will be randomized individually, after stratification by gender, to receive the P2W or the HF2W curriculum. Both manualized curricula will be implemented at each site as originally designed, and surveys will be administered, in parallel time frames. Outcomes as reported by parents and by their designated adolescent child will be tracked over time through self-administered pretest and post-test questionnaires delivered on electronic platforms. Focus groups with parents will be conducted at each of the four study sites, after each of the two full implementation years, to provide insight into how P2W influenced their lives. An ongoing implementation review process will systematically record implementation decisions, challenges and solutions as identified by a range of stakeholders both within and across the four urban AI communities. Phase 3 will include data analysis and dissemination activities to community and academic audiences.

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

Primary outcomes:
measure: Change from baseline in family functioning and cohesion
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in parental involvement
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in parental supervision
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in parental monitoring
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in positive parenting practices
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in relational warmth
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in relational hostility
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in family conflict
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in parental self-agency
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in effective discipline
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in parental communication about sex
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in child problem behaviors.
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in decision making about risk behaviors
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in substance use
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in risky sexual behaviors
timeFrame: 10 week and 12 month follow up
Secondary outcomes:
measure: Change from baseline in depressive symptoms
timeFrame: 10 week and 12 month follow up
measure: Change from baseline in suicidality
timeFrame: 10 week and 12 month follow up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Indian Center
state: Arizona
city: Denver
country: United States
facility: Denver Indian Center
state: Colorado
city: Saint Paul
country: United States
facility: Ain Dah Yung Center
state: Minnesota
city: Buffalo
country: United States
facility: Native American Community Services Erie and Niagara Counties
state: New York
Study officials:
References: