Clinical trial NCT04114864: A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Adolescent - Emotional Problem
Mental Health Wellness 1
Caregivers
Primary Prevention
Cognitive Therapy
Keywords: Adolescent
Acceptance and Commitment Therapy, Cognitive therapy
Mindfulness
Europe
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
Collaborators: name: LINNEUNIVERSITETET (LNU), Sweden (leading the consortium)
name: EUROCARERS-ASSOCIATION EUROPEENNE TRAVAILLANT AVEC ET POUR LES
name: THE UNIVERSITY OF SUSSEX (UoS), UK
name: CARERS TRUST (Carers Trust), UK
name: STIFTUNG KALAIDOS FACHHOCHSCHULE (Kalaidos FH), SW
name: MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (NLNA), NL
name: STICHTING VILANS (VILANS), NL
name: ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT
name: ANZIANI E NON SOLO SOCIETA COOPERATIVA SOCIALE (ANZIANI E), IT
name: UNIVERZA V LJUBLJANI (UL), SI
name: Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre), Kalmar, Sweden
First posted: 2019-10-03
Enrollment: 295
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective C-RCT, with a two (group) by three (time) repeated measures factorial design. Both the intervention and the wait-list control group will be assessed at baseline, immediately post-intervention for the intervention group or after 7 weeks for the wait-list control group - and at the 3MFU.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

The study aim is to evaluate the efficacy of DNA-V-based program for AYCs, called the ME-WE support 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 Self-reported school, training or work experience, performance, and attendance will be used. Control variable will be caring activities; overall amount of caring and likes and dislikes about caring. Results will be compared of the intervention-group participants relative to the wait-list control-group participants from baseline (pre-intervention) through post-intervention and 3-month follow-up (3MFU).

Investigators expect that there will be greater improvements in protective factors targeted by the ME-WE intervention. Thus, it is hypothesized that, compared to the wait-list control group, ME-WE participants will report greater improvements in psychological flexibility, mindfulness, resilience, subjective mental health and quality of life as well as in perceived emotional impact of caring and social support (primary outcomes), and these effects will be maintained at the 3MFU. The impact of ME-WE on self-reported school, training or work experience, performance, and attendance of AYCs (secondary outcomes) will be also explored. Since the intervention will not address these variables directly, we consider them as secondary outcomes.

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). All evaluation self-report instruments are available online. Five open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic (how participants were affected by pandemic, what kind of support and services they received, how their mental and/or physical health has been affected and how they experience the participation in intervention).

Eligibility criteria: Inclusion Criteria:

1. being between 15 and 17 years of age;
2. 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).

Exclusion Criteria:

1. Concurrently participating in other psychotherapies or mindfulness-based interventions/ programmes;
2. 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;
3. limited knowledge of local language (in all countries except Sweden)..

Primary outcomes:
measure: Change from baseline Psychological flexibility at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Mindfulness skills at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Resilience at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Subjective mental health at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Quality of life at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Subjective health complaints at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Caring-related quality of life at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Cognitive and emotional impact of caring at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Change from baseline Social support at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
Secondary outcomes:
measure: Change from baseline Self-reported school, training or work experience, performance, and attendance at 5 months
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
Other outcomes:
measure: Control variables: 1) Caring activities
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: 2) Overall amount of caring
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: 3) Likes and dislikes about caring
timeFrame: baseline, end (after about 7 weeks), follow up after 3 months from completion
measure: Process evaluation outcomes (for intervention group only):
timeFrame: follow up after 3 months from completion
measure: Process evaluation outcomes
timeFrame: end (if applicable), follow-up after 3 months from completion
Locations:
city: Carpi
country: Italy
facility: Anziani e non solo soc. coop. soc
city: Utrecht
country: Netherlands
facility: Stichting Vilans
city: Ljubljana
country: Slovenia
facility: University of Ljubljana
city: Kalmar
country: Sweden
facility: Linnaeus University, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre)
city: Zürich
country: Switzerland
facility: Stiftung Kalaidos Fachhochschule (Kalaidos FH)
city: London
country: United Kingdom
facility: Carers Trust, Print Rooms, 164-180 Union Street, London, SE1 0LN. Carers Trust will be co-ordinating the completion of the interventions for the clinical trials in the UK. All trials for the ME-WE project will be completed in England.
Study officials:
affiliation: Linneus University, Kalmar, Sweden
name: Elizabeth J Hanson, PhD Nursing
role: PRINCIPAL_INVESTIGATOR
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