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

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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Healthy Families in 2 Worlds (HF2W) for adolescent health?

The DULCE program, which is a similar family-focused intervention, showed positive effects on parent resilience and agency, suggesting that family-centered programs can effectively support parental roles and reduce stress, which may benefit adolescent health. ^{1 2 3 4 5}

Is the Parenting Program for Adolescent Health safe for humans?

The research articles do not provide specific safety data for the Parenting Program for Adolescent Health or its related programs. However, evidence-based parenting interventions, in general, are considered safe and have been shown to reduce adolescent behavioral health concerns. ^{2 3 6 7 8}

How is the Parenting in 2 Worlds (P2W) treatment different from other parenting programs for adolescents?

Parenting in 2 Worlds (P2W) is unique because it specifically addresses the cultural and social challenges faced by adolescent parents, focusing on enhancing parent-child interactions and community involvement, unlike other programs that may not target these specific areas. ^{2 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Participation in Pediatric Primary Care Innovation, DULCE, Increases Caregiver Agency and Resilience and Decreases Impact of Stress. [2023]

2. England pubmed.ncbi.nlm.nih.gov

'Living with Teenagers': feasibility study of a peer-led parenting intervention for socially disadvantaged families with adolescent children. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Peer-to-Peer Psychoeducational Intervention for Parents of Black Children Awaiting a Developmental Evaluation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Internet parent-child interaction therapy (I-PCIT) in medically ill child: A case report. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a parent training program in (pre)adolescence: evidence from a randomized controlled trial. [2019]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Sustaining and broadening intervention impact: a longitudinal randomized trial of 3 adolescent risk reduction approaches. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology. [2022]

11. United States 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Young parenthood program: supporting positive paternal engagement through coparenting counseling. [2021]