Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,280
- 试验地点
- 2
- 主要终点
- Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale
研究概览
简要总结
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.
详细描述
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 evaluation 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 and cultural adaptation of the PLH for Parents and Teens program. In Phase 2, a multi-country factorial trial tested different combinations of three additional components (adolescent mental health tools from UNICEF's Helping Adolescents Thrive comics, adolescent peer support, and engagement boosters) and identified the optimized intervention package.
This protocol describes the evaluation (Phase 3) of the optimized FLOURISH intervention package. The randomized waitlist controlled trial will recruit adolescent-caregiver pairs (320 to 340 families per country, 640 to 660 total) to test the effectiveness, cost-effectiveness, and scalability of the optimized PLH program. Families assigned to the intervention group will receive the program over seven weeks (one pre-program visit and six weekly group sessions), while families in the waitlist control group will receive the intervention after the six-month follow-up assessment. The results of this study will inform the potential for scaling up the optimized intervention at the national level in both countries and contribute robust evidence on adolescent mental health promotion in LMICs.
A first version of this ClinicalTrials.gov record was completed in the PRS system on October 3, 2025, prior to participant recruitment. Due to disruptions related to the U.S. government shutdown affecting ClinicalTrials.gov processing during October/November 2025, there was a delay in public release of the record. Participant recruitment began on October 24, 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Caregivers:
- •Must be 18 years or older at baseline assessment
- •Must be the primary caregiver of an adolescent aged 10-14 who has resided in the same household for at least four nights a week in the past month
- •Must be able to speak at least one of the local languages in which the program will be offered (e.g., Macedonian, Romanian, Russian, Ukrainian or Albanian)
- •Must agree to participate in the program and provide informed consent for both themselves and their adolescent
- •For Adolescents:
- •Must be aged 10-14 at the baseline assessment
- •Must provide assent to participate in the study
- •Must have caregiver consent to participate.
排除标准
- •No formal exclusion criteria have been established for the FLOURISH project. However, during the study introduction, the research team will guide participants through a consent form that asks whether they are currently experiencing acute distress or a mental or physical health condition that could interfere with participation. The decision to participate will be made by the individual. If a potential participant indicates they are unable to take part due to acute health issues, the research team will provide appropriate referrals to other services.
研究组 & 干预措施
Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
Families assigned to this arm will receive the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program. The intervention is delivered in groups of approximately 10 adolescent-caregiver pairs over a 7-week period. It includes one pre-program visit and six weekly group sessions (about two hours each), with a mix of joint and separate sessions for caregivers and adolescents. Sessions are facilitated by trained professionals under ongoing supervision to ensure fidelity. The program focuses on strengthening family relationships, improving communication, managing emotions, problem-solving, and promoting positive parenting.
干预措施: Optimized Parenting for Lifelong Health (PLH) for Parents and Teens (Behavioral)
Waitlist Control
Families assigned to this arm will not receive the intervention during the initial study period. They will complete all study assessments at baseline, post-intervention, and 6-month follow-up. After completion of the 6-month follow-up assessment, families in the waitlist control arm will be offered the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program under the same delivery format as the intervention group.
结局指标
主要结局
Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale
时间窗: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
The PSC-17 (caregiver-report) includes 17 items, with responses from 0 (never) to 2 (often) and assesses adolescents' psychosocial functioning. The internalizing subscale includes 5 items. Higher scores indicate more emotional problems.
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale general functioning
时间窗: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. It consists of 12 items. Scoring is on a 4-point scale (from 1 = strongly agree to 4 = strongly disagree). Higher scores indicate poorer family functioning.
Change in frequency of parenting practices in caregivers (caregiver-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting
时间窗: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Parenting practices will be assessed with the caregiver-report version of the APQ. The APQ is a self-report measure of parenting behaviors designed to assess practices most related to children's behavioral adjustment. Items are rated on a 5-point scale from 1 (never) to 5 (always). Higher scores on the involved and positive parenting subscales indicate more positive parenting practices. It is completed by caregivers.
Change in caregiver health-related quality of life: EQ-5D-5L
时间窗: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
The EQ-5D-5L is a standardized instrument developed to measure health-related quality of life. It consists of five dimensions, each rated on a 5-point scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, it includes a visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher dimension scores indicate more health problems; higher VAS scores indicate better self-rated health. It is completed by caregivers.
Change in adolescent health-related quality of life: EQ-5D-Y-3L
时间窗: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
The EQ-5D-Y-3L is a standardized instrument designed to measure health-related quality of life in children and adolescents. It consists of five dimensions, each rated on a 3-point scale: no problems, some problems, severe problems. It also includes a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). Higher dimension scores indicate more health problems; higher VAS scores indicate better self-rated health. It is completed by adolescents.
次要结局
- Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of emotional and behavioral problems in adolescents (adolescent-report): Pediatric Symptom Checklist (PSC-17), internalizing, externalizing and attention subscales, total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, subscales emotional regulation, problem-solving, interpersonal skills(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of loneliness in caregivers: Revised UCLA Loneliness Scale (RULS-6), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in frequency of parenting practices (adolescent-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scale (RCADS), depression and anxiety subscales, total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of bullying involvement in adolescents: Health Behaviour in School-aged Children (HBSC), peer violence subscale(Pre-assessment and 6-month follow-up)
- Change in levels of parent-child communication in adolescents: Parent-Child Communication scale(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), emotional and affectionate subscales(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of psychological distress in caregivers: Patient Health Questionnaire-9 (PHQ-9), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in frequency of parenting practices in caregivers: Alabama Parenting Questionnaire (APQ), subscale corporal punishment(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in frequency of emotionally maltreating behaviors in caregivers: International Child Abuse Screening Tool (ICAST), emotional maltreatment subscale(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of social support in caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), emotional and affectionate subscales(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of family functioning in caregivers: Family Assessment Device (FAD), problem solving subscale(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of well-being in caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in caregiver-reported resource use in adolescents (caregiver-report): PECUNIA Resource Use Measurement (PECUNIA RUM)(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of parent-child communication in caregivers: Parent-Child Communication Scale(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of emotional and behavioral problems in adolescents (caregiver-report): Pediatric Symptom Checklist (PSC-17), externalizing and attention subscales, total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)
- Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score(Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up)