ParentingPhase 2(P2W)NCT06324318
Parenting in 2 Worlds Multisite Trial
A Phase 2 study testing Parenting in 2 Worlds (P2W) and Healthy Families in 2 Worlds (HF2W) in people with Parenting and Mental Health Wellness 1, run by Arizona State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Mental Health Wellness 1, Substance Use
- What is being tested?
- Parenting in 2 Worlds (P2W) and Healthy Families in 2 Worlds (HF2W)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Sep 2023to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Aged 12 - 17
- Identified by their parent/guardian as American Indian
- Attends an urban school
Who cannot join
- Not applicable
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Native American Community Services Erie and Niagara Counties
Buffalo, New York, 14207
Michael Martin, 716-299-0914, mmartin@nacswny.org
- Recruiting
Denver Indian Center
Denver, Colorado, 80219
Rick Waters, 303-936-2688, rick@denverindiancenter.org
- Recruiting
Phoenix Indian Center
Phoenix, Arizona, 85012
Jolyana Begay-Kroupa, 602-264-6768, jbegay-kroupa@phxindcenter.org
- Recruiting
Ain Dah Yung Center
Saint Paul, Minnesota, 55104
Amy Arndt, 651-227-4184, amy.arndt@adycenter.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Parenting in 2 Worlds (P2W), Healthy Families in 2 Worlds (HF2W)
- Keywords
- family functioning, risky sexual behavior
- Medical subject headings
- Substance-Related Disorders, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting in 2 Worlds (P2W)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parenting in 2 Worlds (treatment) | Experimental | A 10-week parenting intervention focused on improving overall family functioning and strengthen parenting skills to communicate with adolescents to avoid risk behaviors. Receives: Behavioral: Parenting in 2 Worlds (P2W) |
| Healthy Families in 2 Worlds | Active comparator | A 10-week parenting intervention curriculum focused on improving parental knowledge of family health topics. Receives: Behavioral: Healthy Families in 2 Worlds (HF2W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 week and 12 month follow up
Secondary outcomes (2)
Change from baseline in depressive symptoms
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.
Measured: 10 week and 12 month follow up
Change from baseline in suicidality
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.
Measured: 10 week and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start14 Sep 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Indian Center, Ain Dah Yung Center, Denver Indian Center Inc, Native American Community Services of Erie and Niagara Counties, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324318
- Sponsor's protocol ID
- R01DA056417
- Other IDs
- R01DA056417
- Acronym
- (P2W)
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiregional RCT of Parenting in 2 Worlds for Urban American Indian Families
- ClinicalTrials.gov ID
- NCT06324318
- Acronym / sponsor ID
- (P2W) / R01DA056417
- Keywords
- family functioning, risky sexual behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Phoenix Indian Center, Ain Dah Yung Center, Denver Indian Center Inc, Native American Community Services of Erie and Niagara Counties, National Institute on Drug Abuse (NIDA)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting in 2 Worlds (treatment) | Experimental | Behavioral: Parenting in 2 Worlds (P2W)A 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 comparator | Behavioral: Healthy Families in 2 Worlds (HF2W)A 10-week parenting intervention curriculum focused on improving parental knowledge of family health topics. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Aged 12 - 17
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Parenting in 2 Worlds (treatment) |
| 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. | Behavioural | Healthy Families in 2 Worlds |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parenting in 2 Worlds (P2W) and Healthy Families in 2 Worlds (HF2W) in people with Parenting and Mental Health Wellness 1, run by Arizona State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen S Kulis, PhD (480-285-7419, kulis@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in family functioning and cohesion (time frame: 10 week and 12 month follow up). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.