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

Mental Health Wellness 1 Clinical Trial

— ME-WE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114864
• Other study ID #: 754702
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 20, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2022
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: June 30, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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)..

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Italy	Anziani e non solo soc. coop. soc	Carpi
Netherlands	Stichting Vilans	Utrecht
Slovenia	University of Ljubljana	Ljubljana
Sweden	Linnaeus University, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre)	Kalmar
Switzerland	Stiftung Kalaidos Fachhochschule (Kalaidos FH)	Zürich
United Kingdom	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

Sponsors (12)

Lead Sponsor

Collaborator

Valentina Hlebec

ANZIANI E NON SOLO SOCIETA COOPERATIVA SOCIALE (ANZIANI E), IT, CARERS TRUST (Carers Trust), UK, EUROCARERS-ASSOCIATION EUROPEENNE TRAVAILLANT AVEC ET POUR LES, ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT, LINNEUNIVERSITETET (LNU), Sweden (leading the consortium), MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (NLNA), NL, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre), Kalmar, Sweden, STICHTING VILANS (VILANS), NL, STIFTUNG KALAIDOS FACHHOCHSCHULE (Kalaidos FH), SW, THE UNIVERSITY OF SUSSEX (UoS), UK, UNIVERZA V LJUBLJANI (UL), SI

Countries where clinical trial is conducted

Italy,  Netherlands,  Slovenia,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Control variables: 1) Caring activities	1) Caring activities: Multidimensional Assessment of Caring Activities (MACA-YC18; Joseph, Becker, Becker, & Regel, 2009); 18 items on a 3-point scale: 'never', 'some of the time' and 'a lot of the time'; total score and six subscale scores for domestic tasks, household management, personal care, emotional care, sibling care, and financial/ practical care.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Other	2) Overall amount of caring	Two open ended ad hoc questions with a number of hours as a response option (hours or caring per week for a typical day during week and at the weekend)	baseline, end (after about 7 weeks), follow up after 3 months from completion
Other	3) Likes and dislikes about caring	Three open ended, ad hoc questions regarding which one of their caring jobs they like the most, dislike the most or it upsets them the most?	baseline, end (after about 7 weeks), follow up after 3 months from completion
Other	Process evaluation outcomes (for intervention group only):	- Post Intervention Self-Assessment adapted for the present study (PISA-CT2012; Joseph et al., 2009). Five open ended questions regarding e.g. the help and support they have been getting from the intervention, things that have changed for them because of attending this project, things they liked or didn't like about attending the project.	follow up after 3 months from completion
Other	Process evaluation outcomes	Four open ended items evaluating COVID-19 impact on participants	end (if applicable), follow-up after 3 months from completion
Primary	Change from baseline Psychological flexibility at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Mindfulness skills at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Resilience at 5 months	Brief Resilience Scale (BRS; Smith 2008); six items on a 5-point Likert scale (from 'strongly disagree' to 'strongly agree'), overall total score.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Subjective mental health at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Quality of life at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Subjective health complaints at 5 months	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').	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Caring-related quality of life at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Cognitive and emotional impact of caring at 5 months	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.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Primary	Change from baseline Social support at 5 months	: Brief Social Support Questionnaire (BSSQ; Sarason, Sarason, Shearin, & Pierce et al., 1987); 6 items with number of support sources as the response option.	baseline, end (after about 7 weeks), follow up after 3 months from completion
Secondary	Change from baseline Self-reported school, training or work experience, performance, and attendance at 5 months	Closed ended, ad hoc questions regarding current education, training, or work, experiencing difficulties and effect of caring.; Two open ended questions with a number of days as a response option (days being late or missed at school, training or work because of caring in the last 2 weeks of term time).	baseline, end (after about 7 weeks), follow up after 3 months from completion