Assessing Implementation of Delivering Community-based, Peer-led Interventions for Mental Health Problems Among Youth in Eldoret, Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Strengths and Difficulties Questionnaire (SDQ)
研究概览
简要总结
Introduction: Mental health disorders are a leading cause of disability among youth globally, and this has been worsened by the COVID-19 pandemic. In low and middle-income countries like Kenya and in rural Indiana, there is an enormous treatment gap for youth mental disorders due to limited mental health care resources.
Goals: The purpose of this project is to examine the implementation of community-based, peer-led management of mental health care screening, and treatment for adolescents in Eldoret, Kenya using the REAIM framework.
Methods: We shall conduct a one-week training to peer-mentors on screening for common mental health problems using the SDQ, PHQ-9, GAD-7, and YTP and treating adolescents who screen positive using a 5 session Problem Solving Treatment (PST), an evidence-based treatment for common youth mental health problems. We will then select five of the peers to deliver the intervention under the supervision of the study team at the largest community-based youth drop-in center, Family Health Options Kenya (FHOK), in Eldoret, where the peers already provide mentorship to adolescents. We will use the REAIM Framework to assess the reach, effectiveness, adoption, implementation, and maintenance of this intervention.
详细描述
Study Design The investigators will conduct a mixed-methods evaluation with peer providers, participants, and key delivery stakeholders such as FHOK staff. The investigators will collect quantitative data from: (1) peer mentors prior to their training and during the delivery of screening and treatment, (2) participants prior to entering treatment and after treatment. The investigators will track rates of retention, engagement, and attrition during screening and treatment delivery. Lastly, he investigators will collect qualitative data including interviews with 10 purposively sampled participants and Focus Groups with peer mentors and key delivery stakeholders post-treatment.
Study Sample. Based on available rates the investigators anticipate identifying around 360 teens with mental health problems in a 6-month period (20 teens per day, global rate of adolescent mental health problem ~15%)22. Linkage and treatment retention rates are low for this population ranging from 28%-78%23 . The investigators conservatively anticipate 45% attrition, resulting in a final sample of 162 receiving treatment. To estimate a pilot treatment effect for participants, a sample of 40 participants is needed to detect a small to medium treatment effect at 80% power and an alpha of 0.05. This effect is commensurate with those shown in previous RCT trials of PST delivered by lay providers24. As such, the investigators believe they will have enough participants to estimate a treatment effect and determine sample size estimates for a future cluster RCT trial. A power calculator was used to estimate a sample size needed to detect a medium effect size with a one group sample (Rosner B. Fundamentals of Biostatistics. 7th ed. Boston, MA: Brooks/Cole; 2011.) Notably, the effects in this study are preliminary indicators of implementation of the intervention and will be used to estimate power for a future, larger trial of PST.
The investigators will use convenience sampling, screening participants who present to the family health center for services. Such an approach best mirrors real world practice and can help provide key preliminary data around reach and service penetration to inform what implementation strategies may need to be applied later to improve implementation outcomes. Sample gender distribution will most likely mirror rates of gender distribution among youth attending Family Health services.
Data Collection Peer Logbooks/Forms: Peers will be provided screening and therapy logbooks to record all study data. These will be used to record number screened, screening results, and attendance to PST sessions for evaluating above metrics for reach, adoption, and implementation. Forms for SDQ, YTP, PHQ-9, and GAD-7 will be provided to peers for baseline screening, 1-month follow-up and 6-month follow-up for measuring effectiveness. Study Protocol will be for all logbooks and forms to be submitted to study office on a daily basis to be locked in a cabinet for confidentiality. The Youth Top Problem (YTP) assessment is a brief idiographic instrument designed to help identify and monitor youth problems that are especially important from the perspectives of the youth and the caregiver11, The Strengths and Difficulties Questionnaire (SDQ) a tool that assesses mental health problems among youth ( emotional symptoms, conduct problems ,Hyperactivity/inattention , peer relationship problems. social behavior) both of which have been used previously in Kenya,33. The investigators shall also use Patient Health Questionnaire (PHQ-9) a brief screening tool for depression. It is a 9-item self-report instrument for screening, and assessing the severity of depression, and examines for symptoms over the past two-week period. Each of the 9 items is rated as follows: 0 - "not at all", 1 - "Several days", 2 - "More than half the days", 3 - "Nearly every day". Interpretation of the total scores is as follows; 0-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression50. The PHQ-9 has been validated in a low income Sub-Saharan Africa setting49. The investigators will use Generalized Anxiety Disorder 7 ( GAD-7 ) a tool for assessing generalized anxiety disorder, and these too have been widely used in the Kenyan setting. It is a seven item self-report instrument that examines for symptoms over the past two-week period. Each item is rated on a 4-point scale as follows: 0 - "not at all", 1 - "Several days", 2 - "More than half the days", 3 - "Nearly every day". Such scores have been shown to have a sensitivity of 89% and a specificity of 82%.51. The GAD-7 has been validated in a low income Sub-Saharan Africa setting49.
Written tests and Peer role plays: Peer mentor PST knowledge and competency will be measured with a written test assessing PST content and coded role plays (pre-post training) on clinical competency measured with the Enhancing Assessment of Common Therapeutic factors (ENACT) rating scale. This was previously used in Kenya to assess lay provider competency.26,27 Recording of PST sessions: PST sessions will be recorded to assess fidelity to PST measured with an adherence checklist outlining the steps of PST in each session (coding and analysis described below).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet any ONE of the following FOUR criteria: (1) a score a 5 or higher on the PHQ-9 OR (2) a score a 5 or higher on the GAD-
- •Youth reporting suicidality on the PHQ-9 will be referred for mental health care and offered to enroll in PST.
排除标准
- •intoxicated from any substance
- •require urgent medical care
- •receiving another mental health intervention
- •show visible language difficulties (unable to understand assent process)
结局指标
主要结局
Strengths and Difficulties Questionnaire (SDQ)
时间窗: On enrollment, at end of PST and six month follow-up
This is a brief behavioral screening questionnaire for 2-17 year olds to assess mental health problems ( emotional symptoms, conduct problems, hyperactivity/inattention , peer relationship problems. social behavior). The overall SDQ score ranges from 0 to 50, with a higher score indicating abnormal behaviors.
Patient Health Questionnaire 9 (PHQ-9)
时间窗: On enrollment, at end of PST and six month follow-up
This is a brief screening tool for depression. Scale is from 0 to 27 with a higher score being more severe disease.
Generalized Anxiety Disorder 7 (GAD-7)
时间窗: On enrollment, at end of PST and six month follow-up
This is a tool for assessing generalized anxiety disorder. Scale is from 0 to 21 with a higher score being more severe disease.
Youth Top Problem (YTP)
时间窗: On enrollment, at end of PST and six month follow-up
a brief idiographic instrument designed to help identify and monitor youth problems that are especially important from the perspectives of the youth and the caregiver
次要结局
未报告次要终点
研究者
Matthew Turissini
Assistant Professor of Clinical Medicine, Department of Medicine, Indiana University School of Medicine
Indiana University
