A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers: a Randomized Control Trial in the Project H2020 ME-WE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 6
- 主要终点
- Change from baseline Subjective health complaints at 5 months
研究概览
简要总结
Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. In Europe, the estimated prevalence rate of YCs is around 4-8%.Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Psychosocial interventions to support YC worldwide are generally quite limited. The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom).
The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project.
The study aim is to evaluate the efficacy of DNA-V based program for AYCs (so-called ME-WE intervention), using a cluster-randomized controlled trial (C-RCT) design. The evaluation of the intervention will be carried out using as primary outcome variables: Psychological flexibility; Mindfulness skills; Resilience; Subjective mental health; Quality of life; Subjective health complaints; Caring-related quality of life; Cognitive and emotional impact of caring and Social support. As secondary outcome variables will be included Self-reported school, training or work experience, performance, and attendance.
COVID-19 Amendment: Recruitment, should be moved to a cluster- based online recruitment or individual, social media recruitment, face-to-face sessions should be moved to online sessions using video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g. ZOOM, Microsoft Teams). Four open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic.
详细描述
Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. Often on a regular basis, they look after family member(s) with a disability, chronic physical and/or mental health condition or substance use issue and/or problems related to old age, who require support or supervision. In Europe, the estimated prevalence rate of YCs is around 4-8%.
Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Furthermore, YCs likely face difficulties in education that negatively impact their future employability and socio-economic status and experience constraints in finding and maintaining employment and pursuing their career aspirations.
Psychosocial interventions to support YC worldwide are generally quite limited. In order to prevent the entrenched level of caring that results in significant and long-term effects on YCs' well-being and hinder transitions to adulthood, it has been suggested that a primary prevention model should be adopted. To prevent adverse mental health, social, and educational outcomes in YCs, building their resilience would be especially important.
The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom).
The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being between 15 and 17 years of age;
- •taking on caring tasks for family member(s) (e.g., parents, siblings, grandparents) with a disability, chronic physical and/or mental health condition or substance use issue and/or problems related to old age (Becker, 2000; Metzing-Blau & Schnepp, 2008).
排除标准
- •Concurrently participating in other psychotherapies or mindfulness-based interventions/ programmes;
- •Having started a new psychotropic medication within the past 30 days or planning on starting or changing psychotropic medication during the course of the study;
- •limited knowledge of local language (in all countries except Sweden)..
研究组 & 干预措施
Experimental
This arm will be receiving the 7 ME-WE sessions psycho-educational intervention. The experimental group will involve a blended approach with 'face to face' meetings in three European partner countries and online sessions (via a ME-WE mobile app) and a purely 'f2f' approach in a further three European partner countries.
干预措施: Psycho-educational sessions (Behavioral)
Control
The control-group will be a wait-list, receiving relaxation exercises during waiting.
干预措施: Psycho-educational sessions (Behavioral)
结局指标
主要结局
Change from baseline Subjective health complaints at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
HBSC Symptom Checklist (HBSC-SCL); 8 items on a 5-point scale ('rarely or never', 'almost every month', 'more than once par week', 'almost every week', 'almost every day').
Change from baseline Psychological flexibility at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Avoidance and fusion questionnaire for youth (AFQ-Y; Greco, Lambert, \& Baer, 2011); 8 items on a 5-point scale (from 'not at all true' to 'very true'), overall total score.
Change from baseline Mindfulness skills at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Child and Adolescent Mindfulness Measure (CAMM; Greco, Baer, \& Smith, 2011); 10 items on a 5-point scale (from 'never true' to 'always true'), overall total score.
Change from baseline Resilience at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Brief Resilience Scale (BRS; Smith 2008); six items on a 5-point Likert scale (from 'strongly disagree' to 'strongly agree'), overall total score.
Change from baseline Subjective mental health at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Warwick Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007); 14 items on a 5-point Likert scale ('none of the time', 'rarely', 'some of the time', 'often', 'all of the time'), overall total score.
Change from baseline Quality of life at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Kidscreen 10 (RavensSieberer, \& the KIDSCREEN Group Europe, 2006); 10 items on 5-point Likert scale from 'not at all / never' to 'extremely / always'; one global health-related quality of life score.
Change from baseline Caring-related quality of life at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Closed ended, ad hoc questions regarding thoughts about hurting themselves/others; being bullied, teased or made fun of; and experiencing some health-related issues because of their caring role.
Change from baseline Cognitive and emotional impact of caring at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
Positive and Negative Outcomes of Caring (PANOC; Joseph et al., 2009; Joseph, Becker, \& Becker, 2012); 20 items on a 3-point scale: 'never', 'some of the time' and 'a lot of the time'; two scores: positive and negative outcomes.
Change from baseline Social support at 5 months
时间窗: baseline, end (after about 7 weeks), follow up after 3 months from completion
: Brief Social Support Questionnaire (BSSQ; Sarason, Sarason, Shearin, \& Pierce et al., 1987); 6 items with number of support sources as the response option.
次要结局
- Change from baseline Self-reported school, training or work experience, performance, and attendance at 5 months(baseline, end (after about 7 weeks), follow up after 3 months from completion)
研究者
Valentina Hlebec
prof. dr. Valentina Hlebec; wp6 leader
University of Ljubljana