A new Phase 3 randomized controlled trial aims to evaluate the impact of a family-focused behavioral intervention on adolescent emotional health and caregiver relationships. This trial, titled ‘Optimized Parenting for Lifelong Health (PLH) for Parents and Teens,’ is currently recruiting participants across multiple international sites.
What changed?
On November 24, 2025, stakeholders in clinical research and regulatory affairs were informed about the launch of a pivotal Phase 3 clinical trial focused on adolescent mental health and family dynamics. This trial is part of the FLOURISH initiative, aiming to enhance psychological well-being by fostering healthier parent-teen relationships.
The intervention being tested, Optimized Parenting for Lifelong Health (PLH) for Parents and Teens, proposes a structured behavioral approach to improve family functioning and adolescent resilience.
Study design and objectives
This randomized controlled trial adopts a rigorous methodology to examine the efficacy and safety of PLH. The study’s primary objectives include:
- Reducing emotional problems in adolescents;
- Improving parent-child relationships and general family well-being;
- Assessing associated psychological outcomes in parents and teenagers.
Participants will undergo pre- and post-intervention assessments, which will help researchers track changes in emotional health and family dynamics over the course of the project.
Target populations
The study seeks to recruit young adolescents experiencing emotional challenges and their caregivers. Caregivers will participate directly in the behavioral intervention program alongside their teenage counterparts.
Eligible candidates are expected to engage actively in the program, which emphasizes practical strategies to strengthen interpersonal communication, emotional self-regulation, and collaborative problem-solving within families.
Collaboration and support
This global initiative involves a collaborative effort led by the University of Klagenfurt in partnership with multiple institutions across Europe, including Cardiff University, Medical University of Vienna, and Bielefeld University. Other contributors include the Health for Youth Association in Moldova and the Institute for Marriage, Family and Systemic Practice – ALTERNATIVA.
The project illustrates a coordinated approach to addressing mental health disparities in adolescents by leveraging expertise from psychology, behavioral sciences, and public health.
FAQ
- What is the goal of this clinical trial?
The trial aims to improve adolescent psychological well-being and family functioning through a behavioral intervention targeting both caregivers and teens. - Who is conducting the trial?
The University of Klagenfurt leads the trial in collaboration with several international academic and clinical institutions. - What are the primary conditions being studied?
The trial focuses on adolescent emotional problems, the parent-child relationship, family dynamics, and psychological well-being. - Is the trial currently recruiting?
Yes, the study is actively recruiting participants at this phase.
Conclusion
The Phase 3 trial for PLH intervention represents a significant step forward in evidence-based strategies to support adolescent mental health. By directly involving families, it aims to create sustainable improvements in emotional well-being for adolescents and their caregivers. Professionals in clinical development, regulatory affairs, and psychological health may find these findings impactful for their fields.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal or medical advice. Health professionals should consult official regulatory documents for compliance-related decisions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07240571?term=medical+device