Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems With Add-On Modules (PROCARE-I+)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 6
- 主要终点
- Absence of emotional disorders
研究概览
简要总结
PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty.
详细描述
The general objetive of PROCARE-I+ is to implement and evaluate an indicated 8-session preventive group intervention with add-on modules for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The intervention will be based on the Unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A), already proven as effective in the US, but adapted with indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program.
METHODOLOGY: In order to achieve this objetive, PROCARE-I+ working plan will be divided into 3 steps. Firstly, in order to identify adolescents at high risk of suffering emotional disorders (anxiety and depression), the following self-reports will be administered to adolescents: Strengths and Difficulties Questionnaire (SDQ) to evaluate adolescents at-risk of emotional disorders, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Then, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. Valuing voices from stakeholders and end-users, the investigators will focus on the study of the influence of the above described variables. Third, the investigators will test PROCARE-I with add-on modules.
IMPACT: The following study will be taken as a pilot study that will allow us to know the strengths and weaknesses of PROCARE-I with add-on modules in order to make future improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •written informed consent from adolescent and legal guardian
- •able to attend prevention modules on his/her own
- •language competence
- •Strengths and Difficulties Questionnaire ""probable diagnoses"
- •score above cut-off for Revised Child Anxiety and Depression Scale-30
- •having incipient symptoms on an emotional level in ADIS 5 C/P
- •absence of anxiety and/or mood disorders
排除标准
- •in- or outpatient
- •concomitant psychological/psychiatric treatment
- •acute suicidality
- •general medical contraindications that hamper attendance to prevention modules
- •have been diagnosed with a neurodevelopmental disorder
- •Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
- •presence of mood and/or anxiety disorders
研究组 & 干预措施
PROCARE-I (UP-A for indicated purposes)
To ensure cost-effectiveness, PROCARE-I intervention will be designed as a brief 8-session child-focused programme by adapting the core modules from UP-A, along with one individual session with adolescent and parents. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness.
干预措施: Active control condition (Behavioral)
PROCARE-I+ 8-session (for indicated purposes)
PROCARE-I+ intervention will be designed as a brief 8-session with 4 additonal sessions (add-on modules) child-focused programme by adapting the core modules from UP-A. Sessions will be delivered in reduced groups, using a typical indicated preventive intervention format focused on cost-effectiveness.
干预措施: PROCARE-I+ 8-session (Behavioral)
结局指标
主要结局
Absence of emotional disorders
时间窗: Baseline to 7 months after start of interventions
The study's primary outcome was absence of any emotional disorders over the long-term measured by the ADIS-5-C/P
Self-reported anxiety and mood symptomatology
时间窗: Baseline to 7 months after start of interventions
The study's primary outcome was self-reported anxiety and mood symptomatology as assessed by Revised Child Anxiety Depression Scale (RCADS-30). Total scores range from 0 to 90. Higher scores mean a worse outcome
Factors associated with adolescents' mental health
时间窗: Baseline to 7 months after start of interventions
The study's primary outcome was self-reported risk and protective factors level of emotional disorders as assessed by Strengths and Difficulties Questionnaire (SDQ). Total scores range from 0 to 50. Higher scores mean a worse outcome.
Resilience measure
时间窗: Baseline to 7 months after start of interventions
This primary measure was intended to measure the resilience of adolescents through 10 items with 5 response options. Scores range from 0 to 40. The higher the score, the greater the resilience.
Health-related quality of life
时间窗: Baseline to 7 months after start of interventions
Secondary outcome assessed included self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. Total scores range from 10 to 50. Higher scores mean a better outcome.
次要结局
- Economic evaluations(Baseline to 7 months after start of interventions)
- Psychological flexibility(Baseline to 7 months after start of interventions)
- Emotional regulation(Baseline to 7 months after start of interventions)
研究者
LuisJoaquin Garcia-Lopez
Full Professor
University of Jaén