A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:

NCT ID: NCT04114864

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2021-06-30

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).

Conditions

Adolescent - Emotional Problem; Mental Health Wellness 1; Caregivers; Primary Prevention; Cognitive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Psycho-educational sessions

Intervention Type: BEHAVIORAL

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.

Control

The control-group will be a wait-list, receiving relaxation exercises during waiting.

Group Type: PLACEBO_COMPARATOR

Psycho-educational sessions

Intervention Type: BEHAVIORAL

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.

Interventions

Psycho-educational sessions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Acceptance and Commitment Therapy - Mental Health- Mindfulness

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)..

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LINNEUNIVERSITETET (LNU), Sweden (leading the consortium)

UNKNOWN

Sponsor Role: collaborator

EUROCARERS-ASSOCIATION EUROPEENNE TRAVAILLANT AVEC ET POUR LES

UNKNOWN

Sponsor Role: collaborator

THE UNIVERSITY OF SUSSEX (UoS), UK

UNKNOWN

Sponsor Role: collaborator

CARERS TRUST (Carers Trust), UK

UNKNOWN

Sponsor Role: collaborator

STIFTUNG KALAIDOS FACHHOCHSCHULE (Kalaidos FH), SW

UNKNOWN

Sponsor Role: collaborator

MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (NLNA), NL

UNKNOWN

Sponsor Role: collaborator

STICHTING VILANS (VILANS), NL

UNKNOWN

Sponsor Role: collaborator

ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT

UNKNOWN

Sponsor Role: collaborator

ANZIANI E NON SOLO SOCIETA COOPERATIVA SOCIALE (ANZIANI E), IT

UNKNOWN

Sponsor Role: collaborator

UNIVERZA V LJUBLJANI (UL), SI

UNKNOWN

Sponsor Role: collaborator

Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre), Kalmar, Sweden

UNKNOWN

Sponsor Role: collaborator

Valentina Hlebec

OTHER

Sponsor Role: lead

Responsible Party

Valentina Hlebec

prof. dr. Valentina Hlebec; wp6 leader

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elizabeth J Hanson, PhD Nursing

Role: PRINCIPAL_INVESTIGATOR

Linneus University, Kalmar, Sweden

Locations

Anziani e non solo soc. coop. soc

Carpi, , Italy

Stichting Vilans

Utrecht, , Netherlands

University of Ljubljana

Ljubljana, , Slovenia

Linnaeus University, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre)

Kalmar, , Sweden

Stiftung Kalaidos Fachhochschule (Kalaidos FH)

Zurich, , Switzerland

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.

London, , United Kingdom

Countries

Italy; Netherlands; Slovenia; Sweden; Switzerland; United Kingdom

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Other Identifiers

754702

Identifier Type: -

Identifier Source: org_study_id