Family-Focused Adolescent & Lifelong Health Promotion - Study Protocol of Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales rule-breaking and aggressive behavior
研究概览
简要总结
The aim of this study is to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
The intervention and training materials will be adapted for the local context and languages (Romanian, Macedonian, and Russian). Facilitators and coaches will be trained to deliver the intervention in the fall of 2023. A pre-post pilot study will be conducted testing the feasibility of the program and the assessment measures with caregivers (30 per country) and their 10-14-year-old children (30 per country). This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' behavioral and emotional problems.
This feasibility study is part of a larger implementation science project using the MOST framework (Multiphase Optimization Strategy). This specific protocol is for the preparation phase of MOST (Phase 1). There are two more phases of MOST that will follow: the optimization phase (Phase 2) and the evaluation phase (Phase 3). The results of Phase 1 will be used to inform any changes to the intervention and assessment measures that may be necessary before testing the intervention in Phase 2, which will involve a randomized factorial trial.
详细描述
Mental health problems during early adolescence are a global concern, especially in low- and middle-income countries (LMICs). North Macedonia and the Republic of Moldova are among the poorest countries in Europe and many children in these countries are exposed to risk factors for negative mental health outcomes, such as family violence. In addition, the recent coronavirus pandemic and war in Ukraine have greatly increased economic, social, and psychological challenges in Eastern Europe. This situation makes the prevention of mental health problems and promotion of well-being among adolescents in North Macedonia and Republic of Moldova a high priority.
Parenting programs are recommended by many health guidelines as evidence-based solutions to support adolescent well-being. One example of a program developed specifically for low- and middle-income contexts is Parenting for Lifelong Health (PLH), a group-based social-behavioral intervention. However, a major challenge of implementing such programs entails sustaining and embedding them into lasting delivery systems (scaling-up). As a result, it is critical to optimize parenting programs in low-resource settings. Specifically, it is essential to identify the most effective and cost-effective components of parenting programs.
The present project, "FLOURISH", aims to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) and the Helping Adolescents Thrive (HAT) Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
FLOURISH will consist of one clinical study with three phases (studies will be registered separately) based on the MOST framework:
Phase 1: Program adaptation and piloting (Preparation of MOST)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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:
- •Age 18 or older at baseline assessment;
- •Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household at least four nights a week in the previous month;
- •Able to speak at least one of the local languages in which the program will be offered (Romanian, Russian, Macedonian)
- •Agreement to participate in the program;
- •Provision of consent for self and child to participate in the study.
- •for Adolescents:
- •Age 10-14 at baseline assessment;
- •Assent to participate in the study;
- •Caregiver consent to participate in the study.
排除标准
- •No formal exclusion criteria have been set for FLOURISH. However, during the process of introducing the project, the research team will guide the participants through a consent form that asks whether they are currently experiencing acute distress or a mental health or physical health condition that would interfere with their participation. The judgement will be made by the potential participant. If the participant decides they are not currently able to take part due to acute health issues, the research team will follow up and provide referrals for other services.
结局指标
主要结局
Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales rule-breaking and aggressive behavior
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is a widely used instrument for assessing child behavioral and emotional symptoms. Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The WHO-5 is a short, positively worded instrument designed to assess the level of emotional well-being over 14 days. Respondents are asked to rate how well each of the 5 statements applies to them when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time) with a range of scores from 0 (absence of well-being) to 25 (maximum score on well-being).
Change in levels of adolescent emotional problems: Revised Child Anxiety and Depression Scales (RCADS), subscales
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The RCADS is a self-report measure developed to evaluate among children symptoms of a number of DSM defined anxiety and depression disorders with two subscales. The RCADS requires respondents to rate how often each item applies to them. Items are scored 0-3 corresponding to ''never,'' ''sometimes,'' ''often,'' and ''always''.
Change in levels of adolescent emotional problems: Child Behavior Checklist (CBCL) 6-18, internalizing subscale
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Change in levels of adolescent emotional problems: Youth Self-Report (YSR) 11-18, internalizing subscale
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The YSR is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscales rule-breaking and aggressive behavior
时间窗: Pre-assessment and 6 - 8 weeks after pre-assessment
The YSR is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). These YSR is widely used for assessing child behavioral and emotional symptoms. Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
次要结局
- Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9)(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting", subscale "parental supervision/monitoring " (parent- and child-report) and subscale "corporal punishment" (parent-report)(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of social support in adolescents and caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional and affectionate subscales"(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of well-being in caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscale externalizing behavior(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score(Pre-assessment and 6 - 8 weeks after pre-assessment)
- Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscale externalizing behavior(Pre-assessment and 6 - 8 weeks after pre-assessment)