Optimizing Multi-level Interventions to Improve Child Mental Health in Azerbaijan
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Changes in child's post-traumatic symptoms using the Revised Child Impact of Events Scale
研究概览
简要总结
To improve mental health outcomes among children aged 7-14 from low-income families in Azerbaijan, this study will refine and test three evidence-based intervention approaches: family-strengthening intervention; trauma-focused mental health services; and economic empowerment in the form of Child Savings Accounts.
Based on prior research on the mental health of deinstitutionalized children conducted by this U.S.-Azerbaijani team in collaboration with a local Community Collaborative Board, these intervention components have been adapted to maximize fit to the cultural context of Azerbaijan. In this study, the adapted interventions will be tested with 600 child-caregiver dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. Given the limited human and financial resources in low- and middle-income countries (LMICs), it will be important to identify whether each of these interventions is necessary and/or sufficient for improving the mental health of children.
The study will test the effects of each intervention component on children's mental health outcomes (symptoms of depression, anxiety; disruptive behaviors; post-traumatic symptoms;), on associated cognitive and social processes (e.g., attention, emotion recognition bias) and functional outcomes (e.g., academic performance). The study will also examine the mediating pathway associated with each intervention component.
详细描述
Despite progress in mental health care reforms across Azerbaijan and other post-Soviet countries toward reducing reliance on a medicalized model, the demand for mental health services still far exceeds available resources. Mental health care is largely centered on a pathology-oriented approach, focused on the short-term alleviation of symptoms, and neglectful of the social and environmental drivers of psychological distress. The chronic hardship and economic deprivation many in Azerbaijan face-along with prolonged exposure to multiple traumatic events and adverse childhood experiences following a series of wars, political upheavals, and refugee crises-can severely undermine families' ability to care for their children's emotional and behavioral wellbeing.
To reduce the service gap, there is a critical need to develop a package of comprehensive community-based psychosocial strategies that improve child mental health outcomes associated with poverty and adversity. According to the National Institute of Mental Health/NIMH's Grand Challenges in Global Mental Health, the advancement of prevention and early intervention (Goal B) is a key priority. This study will contribute to the development of innovative interventions and critical knowledge to address these priorities.
The specific aims of the research study are:
Aim 1: To refine, test, and compare the effects of three interventions (family-strengthening; economic empowerment, and trauma-focused mental health care) on mental health clinical outcomes (including internalizing problems--depression, anxiety, post-traumatic symptoms-and externalizing problems-aggressive or disruptive behavior), b) cognitive and social processes associated with these outcomes (e.g., attention, inhibitory control, working memory, emotion recognition bias), and c) functional outcomes (e.g., academic performance, peer relations) among 7-14-year-old children with or at risk of mental health problems in Azerbaijan.
Aim 2: To examine the role of hypothesized intervention mediators (emotion regulation, supportive parenting, stress reactivity, and economic wellbeing) and moderators (age, gender, family structure, combination of intervention components, and symptom severity) in improving child mental health outcomes.
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)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child is between ages 7 and 14;
- •The child is at-risk for mental health problems as measured by one of the following criteria:
- •Elevated child emotional behavioral problems as indexed by 'high' or 'very high' scores on the Strengths and Difficulties Questionnaire (SDQ, total difficulty score or any of the four difficulty subscales - emotional, conduct, hyperactivity, or peer problems); OR
- •Parental risk factor - parental elevated emotional distress, as indexed by 'severe' or 'extremely severe" score on any of the DASS-21 subscales (DASS-21 Stress = 27; Anxiety = 15; or Depression = 15);
- •The child and parent (or other primary caregiver) can commit to study participation.
- •If a family has more than one eligible child, participation in the study will be offered to the older child. If both the eligible child and caregiver provide consent, they will be enrolled in the study.
- •All eligible children within a family can be enrolled in the study.
排除标准
- •Participants will be excluded from participation in the study if the child, the parent or the participating caregiver is assessed to have a cognitive impairment that would interfere with their ability to provide informed consent. This will be assessed during the consent process. As part of the informed consent process, conducted through an Azeri speaking research assistant, potential participants will also be asked to state their understanding of areas addressed during the informed consent discussion including (1) the nature and extent of participation in the study; (2) risks involved with participation; and (3) the potential benefits of participation in the study. If a participant is unable to respond to any of the three items, this youth/caregiver pair will be excluded from the study.
- •Children and parents will also be excluded if one of them has significant behavioral, and/or mental health impairment (e.g., development disorder, autism, psychosis, high symptoms of trauma or depression) that could interfere with either with their ability to benefit from the prevention program or to participate safely. Research Assistants will ask parents about any of these conditions during the screening process.
研究组 & 干预措施
Family Strengthening, Mental Health, Economic Empowerment
Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Trauma-focused Mental Health Services, and 4) Economic Empowerment Interventions
干预措施: Family Strengthening (Behavioral)
Family Strengthening, Mental Health, Economic Empowerment
Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Trauma-focused Mental Health Services, and 4) Economic Empowerment Interventions
干预措施: Mental Health Screening, Referral and Connection to Services (Behavioral)
Family Strengthening, Mental Health, Economic Empowerment
Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Trauma-focused Mental Health Services, and 4) Economic Empowerment Interventions
干预措施: Economic Empowerment (Other)
Family Strengthening, Mental Health
Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Trauma-focused Mental Health Services
干预措施: Family Strengthening (Behavioral)
Family Strengthening, Mental Health
Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Trauma-focused Mental Health Services
干预措施: Mental Health Screening, Referral and Connection to Services (Behavioral)
Family Strengthening, Economic Empowerment
Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions
干预措施: Family Strengthening (Behavioral)
Family Strengthening, Economic Empowerment
Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions
干预措施: Economic Empowerment (Other)
Family Strengthening Only
Group will receive: 1) Usual Care and 2) Family Strengthening Interventions
干预措施: Family Strengthening (Behavioral)
Mental Health, Economic Empowerment
Group will receive: 1) Usual Care, 2) Trauma-focused Mental Health Services, and 3) Economic Empowerment Interventions
干预措施: Mental Health Screening, Referral and Connection to Services (Behavioral)
Mental Health, Economic Empowerment
Group will receive: 1) Usual Care, 2) Trauma-focused Mental Health Services, and 3) Economic Empowerment Interventions
干预措施: Economic Empowerment (Other)
Mental Health Only
Group will receive: 1) Usual Care and 2) Trauma-focused Mental Health Services
干预措施: Mental Health Screening, Referral and Connection to Services (Behavioral)
Economic Empowerment Only
Group will receive: 1) Usual Care and 2) Economic Empowerment Interventions
干预措施: Economic Empowerment (Other)
Usual Care Only
Group will receive: Usual Care Intervention only
干预措施: Usual Care (Behavioral)
结局指标
主要结局
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.
Change in child mental health 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). Strengths and Difficulties Questionnaire 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, a higher score indicates a worse outcome. For the prosocial scale, a higher score indicates a better outcome. The total score minimum value is 0 and maximum is 40. For all subscales, minimum value is 0 and maximum is 10.
Change in child mental health using the Revised Children's Anxiety and Depression Scale (RCADS)
时间窗: Baseline, 12 months, 24 months
The Revised Children's Anxiety and Depression Scale (RCADS) is a self- and parent-reported measure that assesses a child's internalizing problems, specifically symptoms of anxiety and depression. Sub-scales assess for separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). Results produce a total anxiety score and total internalizing score. Higher scores indicate worse outcomes and a greater severity of anxiety or depression. For the total scale, the maximum score is 141 and the minimum is 0. For the sub scales: Generalized Anxiety Disorder (0 to 15), Social Phobia (0 to 15), Separation Anxiety Disorder (0 to 15), Panic Disorder (0 to 15), Depression (0 to 24)
次要结局
- Change in cognitive functioning using Cambridge Neuropsychological Test Automated Battery(Baseline, 12 months, 24 months)
- Change in school attendance(Baseline, 12 months, 24 months)
- Change in cognitive functioning using Wechsler Intelligence Scale for Children (Fifth Edition)(Baseline, 12 months, 24 months)
- Change in grade average(Baseline, 12 months, 24 months)
- Change in school problem behavior(Baseline, 12 months, 24 months)