Parenting in 2 Worlds Multisite Trial
(P2W)
A Multiregional RCT of Parenting in 2 Worlds for Urban American Indian Families
1 other identifier
interventional
1,440
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2023
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2023
CompletedFirst Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 29, 2026
April 1, 2026
3.6 years
March 15, 2024
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Change from baseline in family functioning and cohesion
Caregiver and adolescent self-report about supportiveness, closeness, togetherness and cooperation among family members. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in parental involvement
Caregiver and adolescent self-report about caregiver's involvement in adolescent's daily activities. Scale: Minimum = 1 and Maximum = 4 \[1 = More than 1 month ago, 2 = Within the last month, 3 = Within the last week, 4 = Yesterday or today\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in parental supervision
Caregiver and adolescent self-report about caregiver's direct supervision such as established curfews. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in parental monitoring
Caregiver and adolescent self-report about caregiver's knowledge of adolescent's activities, friends and whereabouts. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in positive parenting practices
Caregiver and adolescent self-report about caregiver's encouragement for good adolescent behavior. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in relational warmth
Caregiver self-report aspects of the parent-adolescent relationship like caring and responsiveness. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in relational hostility
Caregiver self-report aspects of the parent-adolescent relationship like anger, and demandingness. Scale: Minimum = 1 and Maximum = 5 \[1 = Almost never, 2 = Once in a while, 3 = Sometimes, 4 = Frequently, 5 = Almost always\]. Higher is worse outcome
10 week and 12 month follow up
Change from baseline in family conflict
Caregiver and adolescent self-report about positive and negative interactions in the parent-adolescent relationship. Scale: Minimum = 1 and Maximum = 5 \[1 = Not at all, 2 = Only a little, 3 = Sometimes, 4 = Almost always, 5 = Almost\]. Higher is worse outcome.
10 week and 12 month follow up
Change from baseline in parental self-agency
Caregiver self-reports on confidence in their ability to parent successfully and solve child rearing challenges. Scale: Minimum = 1 and Maximum = 5 \[1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Very often, 5 = Always\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in effective discipline
Caregiver self-reports about difficulty in deciding and establishing effective rules and discipline for their adolescent. Scale: Minimum = 1 and Maximum = 6 \[1 = Strongly disagree, 2 = Disagree, 3 = Disagree slightly, 4 = Agree slightly, 5 = Agree, 6 = Strongly agree\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in parental communication about sex
Caregiver self-reports about how open, responsive, and positive the communication is between parents and adolescents regarding safe sexual behaviors. Scale: Minimum = 1 and Maximum = 4 \[1 =Never, 2 = A few times, 3 = Occasionally, 4 = Frequently\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in child problem behaviors.
Caregiver self-reports about their child's problem behaviors like being withdrawn/depressed, rule-breaking behavior, and aggressive behavior. Scale: Minimum = 0 and Maximum = 2 \[0 = Not true, 1 = Somewhat or sometimes true, 2 =Very true or often true\]. Higher is worse outcome.
10 week and 12 month follow up
Change from baseline in decision making about risk behaviors
Caregiver and adolescent self-report about both positive (e.g., leave the situation) and negative (e.g., react with anger) strategies they use to resist engaging in risk behaviors. Scale: Minimum = 0 and Maximum = 2 \[0 = Never, 1 = Sometimes, 2 =Always. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in substance use
Adolescent self-reports about their use of alcohol, tobacco, marijuana and other drugs in the past 30 days. Single items: Minimum = 0 and Maximum = 6 \[0 = None, 1 = Once, 2 = 2-3 times, 3 = 4-9 times, 4 = 10-19 times, 5 = 20-39 times, 6 = 40 or more times\]. Higher is better outcome.
10 week and 12 month follow up
Change from baseline in risky sexual behaviors
Adolescent self-reports about risky sexual behaviors like not using a condom or consuming alcohol before sexual intercourse. Single items: Minimum = 0 and Maximum = 1 \[0 = No, 1 = Yes\]. Higher is worse outcome.
10 week and 12 month follow up
Secondary Outcomes (2)
Change from baseline in depressive symptoms
10 week and 12 month follow up
Change from baseline in suicidality
10 week and 12 month follow up
Study Arms (2)
Parenting in 2 Worlds (treatment)
EXPERIMENTALA 10-week parenting intervention focused on improving overall family functioning and strengthen parenting skills to communicate with adolescents to avoid risk behaviors.
Healthy Families in 2 Worlds
ACTIVE COMPARATORA 10-week parenting intervention curriculum focused on improving parental knowledge of family health topics.
Interventions
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 guide adolescents to avoid substance use, unprotected sex and other risk behaviors
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arizona State Universitylead
- Phoenix Indian Centercollaborator
- Ain Dah Yung Centercollaborator
- Denver Indian Center Inccollaborator
- Native American Community Services of Erie and Niagara Countiescollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (4)
Phoenix Indian Center
Phoenix, Arizona, 85012, United States
Denver Indian Center
Denver, Colorado, 80219, United States
Ain Dah Yung Center
Saint Paul, Minnesota, 55104, United States
Native American Community Services Erie and Niagara Counties
Buffalo, New York, 14207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 21, 2024
Study Start
September 14, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share