Optimizing Prevention Approaches for Children Reintegrating From Orphanages in Azerbaijan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in child mental health measured using the Strengths and Difficulties Questionnaire (SDQ)
研究概览
简要总结
To prevent mental health problems among 7-12 children from orphanages reunited with their biological or extended families in Azerbaijan, this study will refine and test three evidence-based intervention approaches (a) family strengthening intervention; b) mental health screening and referral for treatment; and c) economic empowerment in the form of Child Development Accounts.
The study will use a randomized experimental design and participating families will be assigned to receive the family strengthening, mental health, or economic interventions. Eligible and consenting 400 child-caregivers dyads will complete baseline, 1-year, and 2-year follow-up measures. Additionally, post-intervention qualitative interviews (n=60) will solicit narrative information about participants' and services providers' reactions and experiences with each intervention component and will provide more comprehensive evidence about the interventions' efficacy.
It is hypothesized that by enhancing children's coping skills, strengthening child-parent relationships, and reducing parental stress, an intervention can help children demonstrate fewer symptoms of: a) disturbances of attachment; b) internalizing problems (depressive or anxious mood), c) externalizing problems (aggressive, delinquent, or disruptive behaviors); d) post-traumatic stress; and e) lower prevalence of diagnoses (e.g. depression, anxiety, PTSD, oppositional-defiant disorder, and reactive attachment disorder).
详细描述
The countries of the former Soviet Union (fSU) and Eastern Europe have the highest number of children in institutional care worldwide--up to 1.3 million children. Institutional care is associated with severe developmental setbacks and poor mental health outcomes for children, and many fSU countries are looking to develop reintegration programs supported by evidence.
Acknowledging the detrimental effects of institutionalization on children, the government of Azerbaijan jointly with UNICEF is implementing a national de-institutionalization program (De-I) aiming to close down orphanages and place children in family-oriented care. The De-I program provides basic case management services to reunite children with their families of origin, but does not address mental health needs of institutionalized children, who after years of isolation, maltreatment and traumatic experiences in orphanages, are returning home to parents who are unprepared to deal with the emotional and behavioral problems of their children. In addition, the current De-I model does not address the family-level poverty which led to institutionalization in the first place, creating a risk for future abandonment and poor psychosocial outcomes.
This study focuses on building research capacity in the field of global mental health to identify effective prevention strategies and develop innovative psychosocial intervention models tailored to the local context of post-Soviet countries. According to the National Institute of Mental Health Grand Challenges in Global Mental Health, advancement of prevention and implementation of early interventions (Goal B) is among the key global mental health priorities. Early prevention reduces the risk of developing mental disorders in adulthood, has long-term impact and may concurrently affect a number of psychosocial outcomes. There are no evidence-based, culturally-tailored, preventive mental health interventions available for institutionalized children in Azerbaijan and other fSU countries. Existing interventions in the U.S. often require highly skilled clinicians and are not adapted for the context of developing countries with limited financial and human mental health resources.
Effective parenting and behavior management skills are essential for preventing emotional and behavioral problems among children. However, in low-resource settings, non-parenting factors such as poverty induced parental stress have also been linked to poor child mental health outcomes and cannot be addressed by parenting skills programs alone. Based on the formative research conducted by the investigative team (2014-2018) in collaboration with a local Community Collaborative Board (CCB), we selected and adapted empirically-tested intervention components to ensure their cultural relevance, viability and inexpensive delivery, essential for developing countries. To promote family stability and improve the emotional well-being among children reuniting with psychosocial functioning of institutionalized children, the proposed intervention will include three components: a) a family-strengthening program, b) referral and access to mental health treatment; and c) economic empowerment. The proposed study will test these intervention components with 400 child-parent dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. If efficacious, the optimized intervention may enhance the traditional De-I model and be scaled up throughout Azerbaijan and other fSU countries.
The specific aims of the research study within the R01 mechanism are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The eligible and consenting child-caregiver dyads will be randomized into one of eight experimental conditions. The randomization will be performed by the Project Director immediately following the baseline visit. A secure, web-based, password-protected database built on a REDCap (Research Electronic Data Capture) platform will be used to randomize participants into the 8 experimental conditions and to manage recruitment; eligibility assessment; scheduling and tracking of baseline and follow-up assessments; and sending intervention reminders. All data collectors (or interviewers) will receive a highly structured and intensive interview training conducted by the PIs. Data collectors and outcome assessors will be masked to participants' intervention group assignment.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child is between ages 7 and 12;
- •The caregiver is at least 18 years old;
- •The child has a history of institutionalization (lived in an orphanage or another institution in Azerbaijan for a minimum of one month);
- •The child has been reunited with a caregiver (biological parent or kin relative) within a year prior to the study;
- •The child has a caregiver who is a biological parent or kin relative (e.g., grandparent) who serves as the primary caregiver;
- •The child and caregiver can commit to study participation.
排除标准
- •Child is not between the ages of 7-
- •Caregiver is below the age of
- •Eligible child and/or caregiver cannot commit to study participation.
- •Children or caregivers with significant cognitive, behavioral, and/ or mental health impairment (e.g., severe developmental disorder, psychosis, severe symptoms of trauma) that may interfere with their ability to consent to and/or benefit from the program or to participate safely will also be excluded from the study.
结局指标
主要结局
Change in child mental health measured using the Strengths and Difficulties Questionnaire (SDQ)
时间窗: Baseline, 12 months, 24 months
Questions assess child's internalizing problems (depression, anxiety) and externalizing problems (aggressive or disruptive behavior). SDQ includes five scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviors reported by parent/caregiver and teacher. With the exception of prosocial behaviors, lower score indicates reduction in mental health symptoms.
Changes in child self-reported symptoms of depression using the Center for Epidemiological Studies Depression Scale for Children (CES-DC)
时间窗: Baseline, 12 months, 24 months
The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a 20 item self-report questionnaire for young people between the ages of 6 and 17. Possible scores ranging from 0 to 60 and lower score indicates a reduction in depressive symptoms.
Changes in child's post-traumatic symptoms using the Revised Child Impact of Events Scale
时间窗: Baseline, 12 months, 24 months
Revised Child Impact of Events Scale (CRIES-8) is a 8-item child-friendly measure designed to screen children at risk for Post-Traumatic Stress Disorder (PTSD). the CRIES-8 has two sub-scales (Intrusion and Avoidance). Total scores range from 0 to 40, with higher scores indicated higher PTSD symptoms. A reduction in trauma symptoms would indicate improvement.
次要结局
- Changes in savings(Baseline, 12 months, 24 months)
- Change in supportive parenting(Baseline, 12 months, 24 months)
- Change in parental stress(Baseline, 12 months, 24 months)