Parenting in 2 Worlds Multisite Trial

Official title

A Multiregional RCT of Parenting in 2 Worlds for Urban American Indian Families

Overview

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.

Interventions

• Behavioral Parenting in 2 Worlds (P2W)
  P2W is a culturally-adapted parenting intervention designed specifically for urban American Indian families. It is a 10-week, 10-lesson manualized curriculum with accompanying videos, designed to be facilitated by American Indians from the local communities. The workshop lessons cover topics like the identification of family values, culturally influenced child rearing values and traditions, sources of support for parents, and ways to improve parenting skills to communicate with, monitor, and gui
• Behavioral Healthy Families in 2 Worlds (HF2W)
  HF2W is a 10-week informational family health program. The workshop lessons cover topics such as oral health, CPR and first aid, dating safety, and teen mental health.

Primary outcome measures

• Change from baseline in family functioning and cohesion [Time frame: 10 week and 12 month follow up]
• Change from baseline in parental involvement [Time frame: 10 week and 12 month follow up]
• Change from baseline in parental supervision [Time frame: 10 week and 12 month follow up]
• Change from baseline in parental monitoring [Time frame: 10 week and 12 month follow up]
• Change from baseline in positive parenting practices [Time frame: 10 week and 12 month follow up]
• Change from baseline in relational warmth [Time frame: 10 week and 12 month follow up]
• Change from baseline in relational hostility [Time frame: 10 week and 12 month follow up]
• Change from baseline in family conflict [Time frame: 10 week and 12 month follow up]
• Change from baseline in parental self-agency [Time frame: 10 week and 12 month follow up]
• Change from baseline in effective discipline [Time frame: 10 week and 12 month follow up]

Secondary outcome measures (2)

• Change from baseline in depressive symptoms [Time frame: 10 week and 12 month follow up]
• Change from baseline in suicidality [Time frame: 10 week and 12 month follow up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 4 centers

• Phoenix Indian Center — Phoenix
• Denver Indian Center — Denver
• Ain Dah Yung Center — Saint Paul
• Native American Community Services Erie and Niagara Counties — Buffalo

Identifiers

NCT: NCT06324318 · R01DA056417 · R01DA056417

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗