Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562244
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Family-Focused Adolescent amp Lifelong Health Promotion Optimization Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being Protocol for a Multi-country Cluster Randomized Factorial Trial FLOURISH Phase 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLOURISH
Brief Summary:
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 UNICEFs Helping Adolescents Thrive comics adolescent peer support based on UNICEFs 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 interventions effectiveness and cost-effectiveness Phase 3 A Phase 2 factorial trial is the focus of this registration
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 interventions effectiveness and cost-effectiveness Phase 3 A Phase 2 factorial trial is the focus of this registration
Detailed Description:
Adolescent mental health is a significant global concern especially in low- and middle-income countries LMICs like North Macedonia and Moldova Adolescents in LMICs face numerous challenges including socio-economic stressors adverse childhood experiences and limited access to mental health services Parenting interventions are one approach to reduce risk for poor adolescent mental health outcomes and family maltreatment Systematic optimization of parenting programs is essential for enhancing scalability and sustainability in low-resource settings
Building on prior research the Family-Focused Adolescent Lifelong Health Promotion FLOURISH project aims to adapt optimize and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova The project focuses on improving adolescent mental health and well-being in both teens and caregivers and it is implemented according to the Multiphase Optimization Strategy MOST framework Phase 1 of the project assessed the feasibility of the adapted parenting intervention which included three components to enhance participation retention and effectiveness The three components were UNICEFs Helping Adolescents Thrive HAT comics peer support and engagement boosters
This protocol describes the optimization Phase 2 of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT adolescent peer support and the engagement boosters as well as their combinations The factorial experiment will consist of eight conditions stratified by country with each condition reflecting a unique combination of the three components The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project Phase 3
Building on prior research the Family-Focused Adolescent Lifelong Health Promotion FLOURISH project aims to adapt optimize and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova The project focuses on improving adolescent mental health and well-being in both teens and caregivers and it is implemented according to the Multiphase Optimization Strategy MOST framework Phase 1 of the project assessed the feasibility of the adapted parenting intervention which included three components to enhance participation retention and effectiveness The three components were UNICEFs Helping Adolescents Thrive HAT comics peer support and engagement boosters
This protocol describes the optimization Phase 2 of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT adolescent peer support and the engagement boosters as well as their combinations The factorial experiment will consist of eight conditions stratified by country with each condition reflecting a unique combination of the three components The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project Phase 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None