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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114864
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : January 22, 2020
Sponsor:
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
Information provided by (Responsible Party):
Valentina Hlebec, University of Ljubljana

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.


Condition or disease Intervention/treatment Phase
Adolescent - Emotional Problem Mental Health Wellness 1 Caregivers Primary Prevention Cognitive Therapy Behavioral: Psycho-educational sessions Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 20, 2019
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Other Name: Acceptance and Commitment Therapy - Mental Health- Mindfulness

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

Other Name: Acceptance and Commitment Therapy - Mental Health- Mindfulness




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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').

  7. 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.

  8. 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.

  9. 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.


Secondary Outcome Measures :
  1. 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 ]

    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).



Other Outcome Measures:
  1. Control variables: 1) Caring activities [ Time Frame: baseline, end (after about 7 weeks), follow up after 3 months from completion ]
    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.

  2. 2) Overall amount of caring [ Time Frame: baseline, end (after about 7 weeks), follow up after 3 months from completion ]
    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)

  3. 3) Likes and dislikes about caring [ Time Frame: baseline, end (after about 7 weeks), follow up after 3 months from completion ]
    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?

  4. Process evaluation outcomes (for intervention group only): [ Time Frame: follow up after 3 months from completion ]
    - 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114864


Contacts
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Contact: Valentina Hlebec, PhD 0038515805248 valentina.hlebec@fdv.uni-lj.si
Contact: Licia Boccaletti, MSc 0039059645421 progetti@anzianienonsolo.it

Locations
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Italy
Anziani e non solo soc. coop. soc Recruiting
Carpi, Italy
Contact: Alessandra Manattini, Msc Psych    0039059645421    a.manattini@anzianienonsolo.it   
Sub-Investigator: Licia Boccaletti, Msc Hum         
Netherlands
Stichting Vilans Recruiting
Utrecht, Netherlands
Contact: Yvonne de Jong       y.dejong@vilans.nl   
Sub-Investigator: Frans Van Zoest         
Slovenia
University of Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Karina Sirk, Msc Soc    +38615805248    Karina.Sirk@fdv.uni-lj.si   
Sub-Investigator: Valentina Hlebec, PhD Soc         
Sweden
Linnaeus University, Nationellt kompetenscentrum anhöriga (Nka), (Swedish Family Care Competence Centre) Not yet recruiting
Kalmar, Sweden
Contact: Lennart Magnusson, PhD Educ    +46 70630231    lennart.magnusson@anhoriga.se   
Contact    +46 703614846    elizabeth.hanson@lnu.se   
Principal Investigator: Elizabeth J Hanson, PhD Nurs         
Switzerland
Stiftung Kalaidos Fachhochschule (Kalaidos FH) Not yet recruiting
Zürich, Switzerland
Contact: Elena Guggiari, MSc HCHM    +41 43 222 64 24    Elena.Guggiari@careum-hochschule.ch   
Contact: Daniel Phelps, BSc. Psych    +44 75 05669237    Daniel.Phelps@careum-hochschule.ch   
Sub-Investigator: Agnes Leu, PhD Law         
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. Recruiting
London, United Kingdom
Contact: Claire Cassidy, Msc SW    0300 772 9600    ccassidy@carers.org   
Sub-Investigator: Eva Jolly, Msc SW         
Sponsors and Collaborators
Valentina Hlebec
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
Investigators
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Principal Investigator: Elizabeth J Hanson, PhD Nursing Linneus University, Kalmar, Sweden

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.
Becker, 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.
Cohen, 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.
Halliburton, 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.
Hamilton, M. G., & Adamson, E. (2013). Bounded agency in young carers' lifecourse-stage domains and transitions. Journal of Youth Studies, 16(1), 101-117.
Hamilton, M., & Cass, B. (2017). Capturing the centrality of age and life-course stage in the provision of unpaid care. Journal of Sociology, 53(1), 79-93.
Harris, R. (2009). ACT made simple: An easy-to-read primer on Acceptance and Commitment Therapy. Oakland, CA: New Harbinger.
Hayes, L., & Ciarrochi, J. (2015). The Thriving Adolescent: Using acceptance and commitment therapy and positive psychology to help teens manage emotions, achieve goals, and build positive connections. Oakland, CA: New Harbinger.
Hayes, S., Wilson, K., & Strosahl, K. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York: Guilford.
Heyman, A. (2013). Partnership working between young carers project and social services. Social Work and Social Sciences Review, 16(3), 50-64.
Heyman, A., & Heyman, B. (2013). 'The sooner you can change their life course the better': The time-framing of risks in relationship to being a young carer. Health, Risk & Society, 15(6-7), 561-579.
Järkestig‐Berggren, U., Bergman, A. S., Eriksson, M., & Priebe, G. (2018). Young carers in Sweden—A pilot study of care activities, view of caring, and psychological well‐being. Child & Family Social Work.
Kallander, E. K., Weimand, B., Ruud, T., Becker, S., Van Roy, B., & Hanssen-Bauer, K. (2018). Outcomes for children who care for a parent with a severe illness or substance abuse. Child & Youth Services. https://doi.org/10.1080/0145935X.2018.1491302
Kallapiran, K., Koo, S., Kirubakaran, R., & Hancock, K. (2015). Effectiveness of mindfulness in improving mental health symptoms of children and adolescents: A meta‐analysis. Child and Adolescent Mental Health, 20(4), 182-194.
Leu, A., Frech, M., Wepf, H., Sempik, J., Joseph, S., Helbling, L., ... & Jung, C. (2018). Counting young carers in Switzerland - A study of prevalence. Children & Society. https://doi.org/10.1111/chso.12296
Leu, A., & Becker, S. (2017). A cross-national and comparative classification of in-country awareness and policy responses to 'young carers'. Journal of Youth Studies, 20(6), 750-762.
Lloyd, K. (2013). Happiness and well-being of young carers: Extent, nature and correlates of caring among 10 and 11 year old school children. Journal of Happiness Studies, 14(1), 67-80.
Merry, S. N., Hetrick, S. E., Cox, G. R., Brudevold-Iversen, T., Bir, J. J. & McDowell, H. (2012) Cochrane Review: Psychological and educational interventions for preventing depression in children and adolescents. Evidence-Based Child Health: A Cochrane Review Journal, 7(5), 1409-1685.
Petts, R. A., Duenas, J. A., & Gaynor, S. T. (2017). Acceptance and Commitment Therapy for adolescent depression: Application with a diverse and predominantly socioeconomically disadvantaged sample. Journal of Contextual Behavioral Science, 6(2), 134-144.
Purcal, C., Hamilton, M., Thomson, C., & Cass, B. (2012). From assistance to prevention: Categorizing young carer support services in Australia, and international implications. Social Policy & Administration, 46(7), 788-806.
Sarason, I. G., Sarason, B. R., Shearin, E. N., & Pierce, G. R. (1987). A brief measure of social support: Practical and theoretical implications. Journal of Social and Personal Relationships, 4(4), 497-510.
Stamatopoulos, V. (2016). Supporting young carers: a qualitative review of young carer services in Canada. International Journal of Adolescence and Youth, 21(2), 178-194.
Swain, J., Hancock, K., Dixon, A., & Bowman, J. (2015). Acceptance and commitment therapy for children: A systematic review of intervention studies. Journal of Contextual Behavioural Science, 4, 73-85.
Swain, J., Hancock, K., Hainsworth, C., & Bowman, J. (2015). Mechanisms of change: Exploratory outcomes from a randomised controlled trial of acceptance and commitment therapy for anxious adolescents. Journal of Contextual Behavioral Science, 1(4), 56-67.

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Responsible Party: Valentina Hlebec, prof. dr. Valentina Hlebec; wp6 leader, University of Ljubljana
ClinicalTrials.gov Identifier: NCT04114864    
Other Study ID Numbers: 754702
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized evaluation data to be stored in data archive with limited access.
Supporting Materials: Study Protocol
Time Frame: After the completion of the project, but the date is unknown.
Access Criteria: not yet known

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valentina Hlebec, University of Ljubljana:
Adolescent
Acceptance and Commitment Therapy, Cognitive therapy
Mindfulness
Europe