African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Older Adolescents With Depression Delivered Through Senior High Schools in Navrongo, Ghana
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
The overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in Ghana. The study is a parallel arm cluster randomised controlled pilot trial. We will recruit adolescents aged 15 to 18 years in senior high schools. Participants will be randomised to receive the Y-MIND psychological intervention or enhanced usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 15 to 18 years in senior high schools located within the Kassena-Nankana Municipality and Kassena-Nankana West District
- •Have scored 10 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9)
- •be willing and able to be followed up for 5 months and provide informed consent or assent
- •For adolescents 15-17 years participants must have 5) access to a caregiver to obtain informed consent
- •All participants must have the ability to read, write and communicate in English language.
排除标准
- •are currently receiving any psychological treatment (talking therapy) for any common mental disorder through formal health care services
- •have active bipolar disorder or psychosis (assessed through a brief screening tool for bipolar disorder and psychosis)
- •have advanced or chronic physical illness (assessed through self-report)
- •have significant visual or hearing impairment which would interfere with their ability to take part in the study
- •are actively suicidal (assessed through the use of a four-item screening tool administered by a psychiatric nurse and reviewed by the trial clinical psychologist
研究组 & 干预措施
Enhanced Usual Care
Enhanced Usual Care (EUC): Guidance and counselling coordinators in the schools provide some counselling to students who need it. Building on the existing structure, enhanced usual care in the Y-MIND programme, will be enhanced in three ways 1) Teaching staff will receive basic training on common mental health conditions affecting youth in Ghana with an emphasis on depression and suicidal symptoms and treatment. 2) Nurses in all schools and other relevant local health care professionals will be trained in mental health, substance-use and self-harm including guidelines on when and where to refer young people for psychiatric care. 3) The study team will provide a letter for the Guidance and Counselling Coordinators for the participant.
干预措施: Enhanced Usual Care (Other)
Y-MIND Intervention
All participants in the intervention arm will receive the EUC plus the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised Guidance and Counselling Coordinators (GCC) at schools in 6 sessions. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the GCC helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)).
干预措施: Y-MIND Intervention (Behavioral)
结局指标
主要结局
Feasibility of the intervention
时间窗: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Feasibility of the intervention will be measured using the 'Feasibility of Intervention Measure' (FIM) with adolescents who received the Y-MIND intervention.
Symptoms of depression
时间窗: 5 months post baseline assessment
Symptoms of depression at 5 months post baseline assessment measured as the difference in mean score on the Patient Health Questionnaire-9 (PHQ-9) between the two arms. Difference in mean PHQ-9 would likely constitute a primary outcome in a later larger definitive trial.
次要结局
- Acceptability and appropriateness of the intervention(At end of Y-MIND intervention sessions or at 5 months post baseline assessment)
- Feasibility of the intervention (Guidance and Counselling Coordinators)(At the end of treatment delivery)
- Fidelity to delivering the psychological intervention(From the first treatment session (week 1) to the end of treatment (week 6))
- Symptoms of anxiety(5 months post baseline assessment)
- Alcohol use(5 months post baseline assessment)