Adolescent - Emotional ProblemPhase 1/2ME-WENCT04114864
A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:
A Phase 1/2 study testing Psycho-educational sessions in people with Adolescent - Emotional Problem and Mental Health Wellness 1, run by Valentina Hlebec at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Adolescent - Emotional Problem, Mental Health Wellness 1, Caregivers
- What is being tested?
- Psycho-educational sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 20 Oct 2019to 30 Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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)..
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Sweden1 site
Linnaeus University, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre)
Kalmar
United Kingdom1 site
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
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Psycho-educational sessions
- Keywords
- Adolescent, Acceptance and Commitment Therapy, Cognitive therapy, Mindfulness, Europe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational sessionsBehavioural
Also called Acceptance and Commitment Therapy - Mental Health- Mindfulness
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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. Receives: Behavioral: Psycho-educational sessions |
| Control | Placebo comparator | The control-group will be a wait-list, receiving relaxation exercises during waiting. Receives: Behavioral: Psycho-educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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').
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
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.
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
Secondary outcomes (1)
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).
Measured: baseline, end (after about 7 weeks), follow up after 3 months from completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start20 Oct 2019
- Primary completion20 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentina Hlebec
- Sponsor type
- University, hospital or other
- Collaborators
- LINNEUNIVERSITETET (LNU), Sweden (leading the consortium), EUROCARERS-ASSOCIATION EUROPEENNE TRAVAILLANT AVEC ET POUR LES, THE UNIVERSITY OF SUSSEX (UoS), UK, CARERS TRUST (Carers Trust), UK, STIFTUNG KALAIDOS FACHHOCHSCHULE (Kalaidos FH), SW, MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (NLNA), NL, STICHTING VILANS (VILANS), NL, ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT, ANZIANI E NON SOLO SOCIETA COOPERATIVA SOCIALE (ANZIANI E), IT, UNIVERZA V LJUBLJANI (UL), SI, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre), Kalmar, Sweden
- Responsible party
- Sponsor-investigator, Valentina Hlebec, University of Ljubljana
- Investigators
- Elizabeth J Hanson, PhD Nursing, Principal investigator, Linneus University, Kalmar, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114864
- Sponsor's protocol ID
- 754702
- Acronym
- ME-WE
- Status last verified
- Nov 2022
- First submitted
- 22 Sep 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized evaluation data to be stored in data archive with limited access.
Publications
Acton, J., & Carter, B. (2016). The impact of immersive outdoor activities in local woodlands on young carers emotional literacy and well-being. Comprehensive Child and Adolescent Nursing, 39(2), 94-106.
Aldridge, J. (2018). Where are we now? Twenty-five years of research, policy and practice on young carers. Critical Social Policy, 38(1), 155-165.
Assaf RR, Auf der Springe J, Siskowski C, Ludwig DA, Mathew MS, Belkowitz J. Participation Rates and Perceptions of Caregiving Youth Providing Home Health Care. J Community Health. 2016 Apr;41(2):326-33. doi: 10.1007/s10900-015-0100-7.
PubMed 26483035Becker, S. (2000). Young carers. In M. Davies (Ed.), The Blackwell encyclopedia of social work (3rd ed.). Oxford: Blackwell.
Becker, S. (2007). Global perspectives on children's unpaid caregiving in the family: Research and policy on 'young carers' in the UK, Australia, the USA and Sub-Saharan Africa. Global Social Policy, 7(1), 23-50.
Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
PubMed 22951546Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Hillsdale, NJ: Erlbaum.
Cunningham, L. C., Shochet, I. M., Smith, C. L., & Wurfl, A. (2017). A qualitative evaluation of an innovative resilience-building camp for young carers. Child & Family Social Work, 22(2), 700-710.
Daniel, W. W. (1999). Biostatistics: A foundation for analysis in the health sciences (7th ed.). New York: John Wiley and Sons.
Fraser E, Pakenham KI. Evaluation of a resilience-based intervention for children of parents with mental illness. Aust N Z J Psychiatry. 2008 Dec;42(12):1041-50. doi: 10.1080/00048670802512065.
PubMed 19016092Gettings S, Franco F, Santosh PJ. Facilitating support groups for siblings of children with neurodevelopmental disorders using audio-conferencing: a longitudinal feasibility study. Child Adolesc Psychiatry Ment Health. 2015 Apr 7;9:8. doi: 10.1186/s13034-015-0041-z. eCollection 2015.
PubMed 25866558Greco LA, Baer RA, Smith GT. Assessing mindfulness in children and adolescents: development and validation of the Child and Adolescent Mindfulness Measure (CAMM). Psychol Assess. 2011 Sep;23(3):606-14. doi: 10.1037/a0022819.
PubMed 21480722Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.
PubMed 18557686Schlarmann JG, Metzing S, Schoppmann S, Schnepp W. Germany's First Young Carers Project's Impact on the Children: Relieving the Entire Family. A Qualitative Evaluation. Open Nurs J. 2011;5:86-94. doi: 10.2174/1874434601105010086. Epub 2011 Oct 26.
PubMed 22135716Halliburton, A. E., & Cooper, L. D. (2015). Applications and adaptations of Acceptance and Commitment Therapy (ACT) for adolescents. Journal of Contextual Behavioral Science, 4(1), 1-11.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04114864
- Acronym / sponsor ID
- ME-WE / 754702
- Conditions
- Adolescent - Emotional Problem, Mental Health Wellness 1, Caregivers, Primary Prevention, Cognitive Therapy
- Keywords
- Adolescent, Acceptance and Commitment Therapy, Cognitive therapy, Mindfulness, Europe
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Valentina HlebecUniversity, hospital or other
- Collaborators
- LINNEUNIVERSITETET (LNU), Sweden (leading the consortium), EUROCARERS-ASSOCIATION EUROPEENNE TRAVAILLANT AVEC ET POUR LES, THE UNIVERSITY OF SUSSEX (UoS), UK, CARERS TRUST (Carers Trust), UK, STIFTUNG KALAIDOS FACHHOCHSCHULE (Kalaidos FH), SW, MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (NLNA), NL, STICHTING VILANS (VILANS), NL, ISTITUTO NAZIONALE DI RIPOSO E CURA PER ANZIANI INRCA (INRCA), IT, ANZIANI E NON SOLO SOCIETA COOPERATIVA SOCIALE (ANZIANI E), IT, UNIVERZA V LJUBLJANI (UL), SI, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre), Kalmar, Sweden
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Psycho-educational sessionsThis 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. |
| Control | Placebo comparator | Behavioral: Psycho-educational sessionsThe control-group will be a wait-list, receiving relaxation exercises during waiting. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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)..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educational sessionsAlso: Acceptance and Commitment Therapy - Mental Health- MindfulnessParticipants 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. | Behavioural | Control, Experimental |
Primary outcome
Change from baseline Psychological flexibility at 5 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Subjective health complaints at 5 months
Time frame: 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 Caring-related quality of life at 5 months
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Change from baseline Self-reported school, training or work experience, performance, and attendance at 5 months
Time frame: baseline, end (after about 7 weeks), follow up after 3 months from completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- BackgroundActon, J., & Carter, B. (2016). The impact of immersive outdoor activities in local woodlands on young carers emotional literacy and well-being. Comprehensive Child and Adolescent Nursing, 39(2), 94-106.
- BackgroundAldridge, J. (2018). Where are we now? Twenty-five years of research, policy and practice on young carers. Critical Social Policy, 38(1), 155-165.
- Background: PubMed 26483035Assaf RR, Auf der Springe J, Siskowski C, Ludwig DA, Mathew MS, Belkowitz J. Participation Rates and Perceptions of Caregiving Youth Providing Home Health Care. J Community Health. 2016 Apr;41(2):326-33. doi: 10.1007/s10900-015-0100-7.
- BackgroundBecker, S. (2000). Young carers. In M. Davies (Ed.), The Blackwell encyclopedia of social work (3rd ed.). Oxford: Blackwell.
- BackgroundBecker, S. (2007). Global perspectives on children's unpaid caregiving in the family: Research and policy on 'young carers' in the UK, Australia, the USA and Sub-Saharan Africa. Global Social Policy, 7(1), 23-50.
- Background: PubMed 22951546Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
- BackgroundCohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Hillsdale, NJ: Erlbaum.
- BackgroundCunningham, L. C., Shochet, I. M., Smith, C. L., & Wurfl, A. (2017). A qualitative evaluation of an innovative resilience-building camp for young carers. Child & Family Social Work, 22(2), 700-710.
- BackgroundDaniel, W. W. (1999). Biostatistics: A foundation for analysis in the health sciences (7th ed.). New York: John Wiley and Sons.
- Background: PubMed 19016092Fraser E, Pakenham KI. Evaluation of a resilience-based intervention for children of parents with mental illness. Aust N Z J Psychiatry. 2008 Dec;42(12):1041-50. doi: 10.1080/00048670802512065.
- Background: PubMed 25866558Gettings S, Franco F, Santosh PJ. Facilitating support groups for siblings of children with neurodevelopmental disorders using audio-conferencing: a longitudinal feasibility study. Child Adolesc Psychiatry Ment Health. 2015 Apr 7;9:8. doi: 10.1186/s13034-015-0041-z. eCollection 2015.
- Background: PubMed 21480722Greco LA, Baer RA, Smith GT. Assessing mindfulness in children and adolescents: development and validation of the Child and Adolescent Mindfulness Measure (CAMM). Psychol Assess. 2011 Sep;23(3):606-14. doi: 10.1037/a0022819.
- Individual participant dataSharing planned: Yes. Anonymized evaluation data to be stored in data archive with limited access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Hanson, PhD Nursing principal investigator
Linneus University, Kalmar, Sweden
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psycho-educational sessions in people with Adolescent - Emotional Problem and Mental Health Wellness 1, run by Valentina Hlebec at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Netherlands, Slovenia, Sweden, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Psychological flexibility at 5 months (time frame: baseline, end (after about 7 weeks), follow up after 3 months from completion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114864, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.