Parenting Program for Adolescent Health

((P2W) Trial)

Recruiting at 3 trial locations

Overseen By Christine McCaleb, MA

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Arizona State University

Disqualifiers: Non-American Indian, Non-urban residents, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a parenting program designed to help American Indian and Alaska Native parents improve family dynamics and communication with their adolescents. The study will compare two programs: Parenting in 2 Worlds (P2W), which enhances parenting skills, and Healthy Families in 2 Worlds (HF2W), which focuses on family health knowledge. Researchers aim to assess how these programs affect adolescent behaviors, such as substance use and mental health. Participants should be American Indian parents living in urban areas who are the primary caregivers for children aged 12 to 17 attending urban schools.

As a Phase 2 trial, this study measures the effectiveness of the programs in an initial, smaller group, offering participants a chance to contribute to important research that could benefit their community.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that participants generally receive the Parenting in 2 Worlds (P2W) program well. In a previous study with 575 parents of American Indian children, the program improved parenting practices, and no negative effects were reported. Although specific safety details for P2W are unavailable, the program's focus on enhancing family communication and parenting skills suggests it poses low risk. As a behavioral program rather than a medical treatment, it is typically considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parenting in 2 Worlds (P2W) program because it focuses on strengthening family dynamics and enhancing communication skills between parents and adolescents, which is crucial for preventing risky behaviors. Unlike traditional parenting programs that may focus solely on knowledge dissemination, P2W emphasizes improving overall family functioning. This holistic approach not only targets parental knowledge but also equips families to better navigate the challenges of adolescence, making it a promising intervention for fostering healthier family environments.

What evidence suggests that this trial's treatments could be effective for improving adolescent health?

Research has shown that the Parenting in 2 Worlds (P2W) program, one of the interventions in this trial, greatly improves parenting skills. In Arizona, parents who participated in P2W experienced significant improvements in managing parenting and felt more in control of parenting situations. They also reported better supervision of their children and fewer discipline problems. Early results suggest that this culturally tailored program can enhance family life, especially for urban American Indian families, and may help reduce risky behaviors in teenagers, such as substance use and depression. Meanwhile, the Healthy Families in 2 Worlds program, another intervention in this trial, focuses on improving parental knowledge of family health topics. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for American Indian/Alaska Native parents or guardians living in urban areas with adolescents aged 12-17. It's designed to help improve parenting and family functioning, especially for those facing socioeconomic challenges, historical loss, or seeking to strengthen AI cultural identity.

Inclusion Criteria

Child participants must be identified by their parent/guardian as American Indian

Adult participants must be American Indian parents or guardians of American Indian children aged 12 to 17 who attend urban schools

Adult participants must self-identify as American Indian

Exclusion Criteria

This criterion does not apply to me.

Timeline for a Trial Participant

Start-up and Planning

Start-up, development, and planning activities coordinated with a Community Advisory Board to prepare for intervention implementation.

Not specified

Training

American Indian workshop facilitators receive 2-day trainings on intervention delivery.

2 days

Intervention Cycle 1

Implementation of one cycle of the P2W intervention and the comparison group intervention, HF2W, including pretest and post-test data collection.

10 weeks

Review and Planning

Video conference to review successful implementation strategies and troubleshoot challenges after the first cycle.

Not specified

Intervention Cycles 2-6

Completion of at least 5 additional cycles of delivering P2W and HF2W.

50 weeks

Follow-up

Participants are monitored for changes in outcomes such as child problem behaviors and family functioning.

12 months

Data Analysis and Dissemination

Data analysis and dissemination activities to community and academic audiences.

Not specified

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Families in 2 Worlds (HF2W)
• Parenting in 2 Worlds (P2W)

Trial Overview The study compares two programs: 'Parenting in 2 Worlds (P2W)' and 'Healthy Families in 2 Worlds (HF2W)'. P2W focuses on culturally grounded parenting skills while HF2W provides general family health information. The goal is to see which program better improves family dynamics and reduces adolescent risky behaviors.

How Is the Trial Designed?

Group I: Parenting in 2 Worlds (treatment) Experimental Treatment 1 Intervention

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

Group II: Healthy Families in 2 Worlds Active Control 1 Intervention

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

Parenting in 2 Worlds (P2W) is already approved in United States for the following indications:

Approved in United States as Parenting in 2 Worlds for:

• Improving parenting and family functioning in urban American Indian/Alaska Native families
• Reducing adolescent risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Ain Dah Yung Center

Collaborator

Trials

1

Recruited

1,400+

Phoenix Indian Center

Collaborator

Trials

1

Recruited

1,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Denver Indian Center Inc

Collaborator

Trials

1

Recruited

1,400+

Native American Community Services of Erie and Niagara Counties

Collaborator

Trials

1

Recruited

1,400+

Published Research Related to This Trial

The Young Parenthood Program (YPP) is an effective 10-week counseling intervention for pregnant adolescents, showing improved positive parenting skills among fathers compared to a control group of 105 participants.

The positive changes in paternal functioning were linked to improvements in the mothers' interpersonal skills, highlighting the importance of involving both parents in parenting support programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young parenthood program: supporting positive paternal engagement through coparenting counseling. Florsheim, P., Burrow-Sánchez, JJ., Minami, T., et al.[2021]

The Parents and Children Talking Together (PCTT) program significantly improved parents' communication and problem-solving skills, as well as reduced dysfunctional disciplining behaviors, based on a study of 78 families with children aged 9-16.

The program was particularly effective for parents with higher socioeconomic status and those with children aged 14 to 16, indicating that these factors may enhance the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a parent training program in (pre)adolescence: evidence from a randomized controlled trial. Leijten, P., Overbeek, G., Janssens, JM.[2019]

The Guiding Good Choices (GGC) program, a 5-session parenting intervention, has been shown to effectively reduce adolescent substance use, depression symptoms, and delinquent behavior, highlighting its potential as a preventive measure.

The current study, involving approximately 3750 adolescents across diverse healthcare systems, aims to assess the feasibility and effectiveness of implementing GGC in pediatric primary care, with the expectation that it will lead to significant reductions in substance use initiation among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-focused prevention of adolescent health risk behavior: Study protocol for a multisite cluster-randomized trial implemented in pediatric primary care. Scheuer, H., Kuklinski, MR., Sterling, SA., et al.[2023]

Internet-parent-child interaction therapy (I-PCIT) conducted at home significantly improved disruptive behaviors in a 5-year-old girl with attention deficit hyperactivity disorder and other medical issues, demonstrating its feasibility and effectiveness during a global pandemic.

The combination of I-PCIT and medication (methylphenidate) helped the child succeed both at home and in school, suggesting that integrated treatment approaches may be beneficial for medically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet parent-child interaction therapy (I-PCIT) in medically ill child: A case report. Melo, V., Zaccariello, M., Girard, E., et al.[2023]

A peer-led parenting intervention called 'Living with Teenagers' was found to be feasible and effective, with a 71% completion rate among 41 participants, primarily from minority ethnic backgrounds and many being lone parents.

The intervention led to significant improvements in parental concern about adolescent behavior and increased parenting satisfaction, indicating its potential to support parents in socially disadvantaged communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Living with Teenagers': feasibility study of a peer-led parenting intervention for socially disadvantaged families with adolescent children. Michelson, D., Ben-Zion, I., James, AI., et al.[2016]

Evidence-based parenting interventions have been shown to effectively improve various outcomes for children and adolescents, including mental and physical health, academic performance, and prevention of maltreatment.

Despite the proven effectiveness of these programs, they are not widely accessible to parents, highlighting the need for policy changes to increase the availability of these supports to address significant health and social issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Policies are Needed to Increase the Reach and Impact of Evidence-Based Parenting Supports: A Call for a Population-Based Approach to Supporting Parents, Children, and Families. Doyle, FL., Morawska, A., Higgins, DJ., et al.[2023]

A randomized controlled trial involving 180 parents is testing the efficacy of the ABCD Parenting Young Adolescents Program, which consists of 6 sessions aimed at improving parent-adolescent relationships and reducing conflict.

The study aims to provide evidence on whether early intervention through parenting programs can enhance adolescent wellbeing and parent psychosocial health, addressing a gap in existing literature on preventive strategies for adolescent behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology. Burke, K., Brennan, L., Roney, S.[2022]

Parenting intervention programs have the potential to significantly improve children's health and development, but many existing programs have not met the necessary standards for effectiveness, leading to failures in large-scale initiatives.

Evidence suggests that certain programs, particularly nurse home visiting for pregnant women and young parents, can produce consistent positive outcomes for children's health and development across diverse populations and settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. Olds, DL., Sadler, L., Kitzman, H.[2022]

The addition of a parental monitoring intervention (ImPACT) to the adolescent risk reduction program (Focus on Kids) significantly reduced risky behaviors such as sexual activity and substance use among 817 black youths aged 12 to 16 over a 12-month period.

While the parental intervention showed lasting benefits in reducing risk behaviors, the booster sessions provided later did not significantly enhance these effects, suggesting that the initial parental involvement is more crucial than additional follow-up sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining and broadening intervention impact: a longitudinal randomized trial of 3 adolescent risk reduction approaches. Wu, Y., Stanton, BF., Galbraith, J., et al.[2022]

The Parent-to-Parent program is a home-based initiative that provides long-term support to adolescent parents through trained volunteers, aiming to improve parent-child interactions and help parents access necessary services.

The program also focuses on increasing community involvement and empowering parents to plan for their futures, addressing the broader developmental needs often overlooked in traditional prenatal and neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community support for adolescent parents and their children: The parent-to-parent program in Vermont. Halpern, R., Covey, L.[2021]

The DULCE intervention, which supports families with infants, showed positive effects on parent agency and resilience, even with low levels of participation, indicating its effectiveness in enhancing parental functioning.

Higher-risk families benefited even more from the DULCE program when they engaged at a higher intensity, highlighting the importance of tailoring interventions to meet individual family needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in Pediatric Primary Care Innovation, DULCE, Increases Caregiver Agency and Resilience and Decreases Impact of Stress. Monahan, E., McCrae, JS., Arbour, M.[2023]

The Parents Taking Action (PTA) intervention, delivered online over two 6-week modules, significantly improved parent depression and family outcomes for 15 Black families of children awaiting developmental evaluations, indicating its potential effectiveness.

Participants reported medium to large improvements in understanding their child's needs and advocating for their rights, suggesting that peer-to-peer support can empower families during the waiting period for evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Peer-to-Peer Psychoeducational Intervention for Parents of Black Children Awaiting a Developmental Evaluation. Dababnah, S., Reyes, C., Kim, I., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4939122/

Parenting in 2 Worlds: Effects of a Culturally Adapted ... P2W participants reported statistically significant improvements in their sense of parental agency, use of positive parenting practices, supervision of the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06324318

NCT06324318 | Parenting in 2 Worlds Multisite Trial This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10926230/

Parenting in 2 Worlds: Testing Improved Parent-Adolescent ... We expected that P2W participants would report significantly larger increases in communication about sex with their children on both dimensions, ...

4. trialx.com trialx.com/clinical-trials/listings/287943/parenting-in-2-worlds-multisite-trial/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Parenting in 2 Worlds Multisite Trial First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, ...

5. globalappliedhealth.asu.edu globalappliedhealth.asu.edu/research/north-america/parenting-2-worlds

Parenting in 2 Worlds Key Findings. In the Arizona test, P2W parents/guardians reported significant improvements in effective parenting practices, sense of parental agency, ...

6. withpower.com withpower.com/trial/phase-2-substance-related-disorders-8-2023-8f4fa

Parenting Program for Adolescent Health ((P2W) Trial) The research articles do not provide specific safety data for the Parenting Program for Adolescent Health or its related programs.