Recruiting
Phase 2

Observational Study

Sponsor:

Arizona State University

Code:

NCT06324318

Conditions

Parenting

Mental Health Wellness 1

Substance Use

Risky Health Behavior

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Parenting in 2 Worlds (P2W)

Healthy Families in 2 Worlds (HF2W)

Study Details

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.

Conditions

Parenting

Mental Health Wellness 1

Substance Use

Risky Health Behavior

Study ID

NCT06324318

Start date

Sep 14, 2023

Status verified date

Apr, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Parenting in 2 Worlds (treatment)

A 10-week parenting intervention focused on improving overall family functioning and strengthen parenting skills to communicate with adolescents to avoid risk behaviors.

active comparator: Healthy Families in 2 Worlds

A 10-week parenting intervention curriculum focused on improving parental knowledge of family health topics.

Interventions

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 guide adolescents to avoid substance use, unprotected sex and other risk behaviors

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 measure

  • 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 ]
  • Change from baseline in parental communication about sex [ Time Frame: 10 week and 12 month follow up ]
  • Change from baseline in child problem behaviors. [ Time Frame: 10 week and 12 month follow up ]
  • Change from baseline in decision making about risk behaviors [ Time Frame: 10 week and 12 month follow up ]
  • Change from baseline in substance use [ Time Frame: 10 week and 12 month follow up ]
  • Change from baseline in risky sexual behaviors [ Time Frame: 10 week and 12 month follow up ]

Central Contacts and Locations

Central contacts

Stephen S Kulis, PhD

480-285-7419kulis@asu.edu

Christine McCaleb, MA

602-496-0261christine.mccaleb@asu.edu

Locations

Phoenix Indian Center

Recruiting

Phoenix, Arizona, United States, 85012

Contacts

Jolyana Begay-Kroupa

602-264-6768jbegay-kroupa@phxindcenter.org

Denver Indian Center

Recruiting

Denver, Colorado, United States, 80219

Contacts

Rick Waters

303-936-2688rick@denverindiancenter.org

Ain Dah Yung Center

Recruiting

Saint Paul, Minnesota, United States, 55104

Contacts

Amy Arndt

651-227-4184amy.arndt@adycenter.org

Native American Community Services Erie and Niagara Counties

Recruiting

Buffalo, New York, United States, 14207

Contacts

Michael Martin

716-299-0914mmartin@nacswny.org

More Information

Sponsor

Arizona State University

Last update posted

Sep 8, 2026

Last verified

Apr, 2026

Keywords

  • family functioning
  • risky sexual behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-09-08.