CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 295 enrolled
Drug / intervention
Psycho-educational sessionsbehavioral
Likely dose
Not stated in record
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Search/NCT04114864
NCT04114864Phase 2Completed

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

Valentina Hlebec·interventional·Posted Oct 3, 2019·Updated Nov 3, 2022

In Brief

A Phase 2 clinical trial evaluating Psycho-educational sessions for Adolescent - Emotional Problem and 4 related conditions. Completed, enrolled 295 participants across 6 sites in 6 countries.

Detailed Summary

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.

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 3, 2019
Enrollment StartOct 20, 2019
Primary CompletionMar 20, 2021
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.7 years ago

Interventions

Psycho-educational sessionsbehavioral

Participants of clusters allocated to the ME-WE intervention group will complete a programme based on seven weekly sessions of approximately 2 hours each, plus a follow-up meeting after 3 months from the end of the programme. All sessions maintain a similar structure (objectives, ice-breaker, central activity/ies, and final activity). At the end of some sessions, participants will be asked to do some exercises at home, between one meeting and the next one, in order to keep what has been done during the previous session fresh in their minds. Contents of sessions will be as follows: (1) Getting to know each other; (2) The Advisor: dealing with annoying thoughts; (3) The Noticer: being in connection with our feelings; (4) The Discoverer: growing and thriving; (5) Values: connecting to meaning and vitality; (6) Developing a flexible self-view and self-compassion; (7) Building strong social networks.