Clinical Research Directory

The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments

The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include: * Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. * Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use. Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks. Participants will: * Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group) * Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention * Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits. * Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker * Be invited to complete a booster session at 6-months post-intervention * Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention

Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

The aim of this study is to conduct a multi-country randomized waitlist controlled trial to evaluate the effectiveness, cost-effectiveness, and scalability of the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. In Phase 2 of the FLOURISH project, a factorial trial tested multiple intervention components and identified the optimized intervention package. In Phase 3, this trial will assess the implementation, outcomes, and economic impact of the optimized PLH program delivered to adolescents aged 10-14 and their caregivers. ALTERNATIVA will deliver the program in North Macedonia and the Health for Youth Association in the Republic of Moldova.

Evaluation of the Family Intervention Program (PIF)

The goal of this study is to evaluate the effectiveness of home positive parenting programs targeted to families at psychosocial risk carried out in Cantabria (Spain). The investigators will collect information before the intervention, and every six months until the family achieves the proposed objectives (with a maximum intervention period of two years). Besides, the investigators will compare these results with information from other families that are not taking part in the program. Depending on the case, the practitioners in charge of the intervention, the main caregivers of the participating families and/or the adolescents will provide the information for the study. The investigators expect that families participating in the programs will improve their parenting competencies, their family dynamics, and the life quality of their children.

All in the Family: Promoting Family Function Through Physical Activity

The goal of this trial is to find out whether adding identity-building and self-regulation training to basic healthy-living education helps families with inactive children (ages 6-12) become more cohesive and physically active. The main question it aims to answer is: Does the identity + self-regulation + education program improve family cohesion more than (a) self-regulation + education or (b) education alone? Researchers will compare three groups-identity+self-regulation+education (ID), self-regulation+education (SR), and education-only (ED)-to see which produces the greatest improvements. Participants will: 1. attend three online workshops at baseline plus two booster sessions at 6-week and 3-month with a project coordinator; 2. complete online questionnaires at baseline, 6-week, 3-month, and 6-month; 3. take part in an exit interview at 6 months.

Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial

The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters. ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova. This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.