Parenting in 2 Worlds Multisite Trial ((P2W))

April 27, 2026 updated by: Arizona State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Stephen S Kulis, PhD
  • Phone Number: 480-285-7419
  • Email: kulis@asu.edu

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
    • Colorado
      • Denver, Colorado, United States, 80219
    • Minnesota
      • Saint Paul, Minnesota, United States, 55104
    • New York
      • Buffalo, New York, United States, 14207
        • Recruiting
        • Native American Community Services Erie and Niagara Counties
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 guide adolescents to avoid substance use, unprotected sex and other risk behaviors
Active Comparator: Healthy Families in 2 Worlds
A 10-week parenting intervention curriculum focused on improving parental knowledge of family health topics.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in family functioning and cohesion
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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.
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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
Time Frame: 10 week and 12 month follow up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in depressive symptoms
Time Frame: 10 week and 12 month follow up
Adolescent self-reports about their symptoms of depression like feeling sad. Scale: Minimum = 1 and Maximum = 4 [1 = Rarely or none of them time (less than 1 day), 2 = Some or a little of the time (1 - 2 days), 3 = Occasionally or a moderate amount of time (3 - 4 days), 4 = All of the time (5 - 7 days)]. Higher is worse outcome.
10 week and 12 month follow up
Change from baseline in suicidality
Time Frame: 10 week and 12 month follow up
Adolescent self-reports about their suicidal ideation and behavior. Scale: Minimum = 0 and Maximum = 4 [0 = Never, 1 = Once, 2 = 1 - 2 times a week, 3 = 3 - 4 times a week, 4 = Daily]. Higher is worse outcome.
10 week and 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Phoenix Indian Center
Ain Dah Yung Center
Denver Indian Center Inc
Native American Community Services of Erie and Niagara Counties

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DA056417 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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