Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale
研究概览
简要总结
The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders.
The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors.
This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).
详细描述
Over the past decade there have been increasing calls for the scale-up of evidence-based interventions in order to reduce the risk of violence against children in low- and middle-income countries (LMICs) (Mikton et al., 2014). In particular, parenting programs for families with young children have been shown to be effective in reducing the risk of child maltreatment and improving child wellbeing with promising evidence emerging from low- and middle-income countries (Barlow et al., 2006; Knerr et al., 2013, Chen & Chan, 2015). These group-based programs typically aim to strengthen caregiver-child relationships through positive parenting and help parents to manage child behavior problems through effective, age-appropriate, nonviolent discipline strategies.
Despite the emerging evidence of the effectiveness of parenting interventions in reducing violence against children, many local governments and service providers in LMICs face multiple challenges implementing evidence-based parenting programs in resource poor contexts (Mikton, 2012). Parenting programs are often too expensive to deliver effectively at scale in low-resource settings due to their complexity, intensity, and length (Knerr et al., 2013). Parenting programs developed and evaluated in other contexts also may not fit the local service delivery context and may require adaptation to be relevant to the local culture of families. Additional program content may also be necessary to address acute economic deprivation, high community violence, and parental distress. The process of delivery may also need to be simplified to improve participant engagement and the quality of delivery.
As a result, it is essential that programs implemented in LMICs are
- effective at reducing violence against children,
- integrated within the existing service delivery system,
- feasible and culturally acceptable to service providers and families, and
- scalable in terms of their affordability, replicability, and sustainability while reaching a maximum number of beneficiaries.
However, there are currently very few parenting programs that meet these criteria in LMICs (such as Romania, FYR of Macedonia and Republic of Moldova), where the need is the greatest.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for caregivers/parents:
- •age 18 or older;
- •primary caregiver responsible for the care of a child between the ages of two and nine;
- •Report elevated levels of child behavior problems for the child he/she chooses to be part of the study (based on the Eyberg Child Behavior Inventory);
- •Have lived in the same household as this child at least four nights a week in the previous month and will continue to do so;
- •agreement to participate in the PLH 2-9 program;
- •Provision of Informed consent to participate in the full stud
排除标准
- •for caregivers/parents: any adult 1) exhibiting severe mental health problems or acute mental disabilities; 2) that has been referred to child protection services due to child abuse.
研究组 & 干预措施
Parenting for Lifelong Health
Parenting Programme "Parenting for Lifelong Health for Young Children" (PLH) for parents of children aged 2-9, 12 sessions
干预措施: Parenting for Lifelong Health for Young Children (Behavioral)
结局指标
主要结局
Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale
时间窗: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
The primary outcome child behavior problems is assessd with two methods: 1) parent-report: Child Behavior Checklist (CBCL). The CBCL is part of the Achenbach System of Empirically Based Assessment (ASEBA) and is available for different age ranges. For the present study, the parent-report versions for children aged 1½ - 5 and 6-18 are employed. It is the most widely used instrument for assessing child behavioral and emotional symptoms. The externalizing subscale raw score ranges from 0 to 70 (CBCL 6-18 version) and 0 to 48 (CBCL ½ - 5 version) and can be converted into standardized scores (e.g., T scores, with Mean = 50, SD = 10) with higher scores indicating more problems.
Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated
时间窗: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
The primary outcome child behavior problems is assessed with two methods: 2) structured interview, clinician-rated: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; (MINI-KID-P) evaluates the presence of current psychiatric disorders (based on ICD-10 and DSM-5). It will be assessed whether or not the criteria for a) conduct disorder (F91.1, F91.2, F91.9) or b) Oppositional Defiant disorder (F91.3) are met (yes/no). The results of the two disorders will be combined to one binary total score with 0 (no externalizing disorder) and 1 (current externalizing disorder (ODD or CD)). As the sample size is small in this study phase, there is no real change in prevalence expected. However, the feasibility of the interview will be tested for later study phases with larger sample sizes.
次要结局
- Change in incidence and frequency of child maltreatment: ISPCAN-Child Abuse Screening Tool -Intervention / self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in Prevalence of Anxiety Disorders in children: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID-P) / Structured Clinical Diagnostic Interview for Parents, Clinician-rated(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in levels of parental well-being: WHO-5 Well-Being Scale/ self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in levels of parental stress: Parenting Stress Index - Short Form (PSI-SF) / self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
- Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report(Pre-Post (approximately 16 - 20 weeks after pre-assessment))
研究者
Prof. Dr. Nina Heinrichs
Prof. Dr. Nina Heinrichs
Technische Universitaet Braunschweig