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

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.

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1; Primary Prevention; Cognitive Therapy; Caregivers; Adolescent - Emotional Problem
• Intervention / Treatment: Behavioral: Psycho-educational sessions

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 Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Acceptance and Commitment Therapy - Mental Health- Mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Process evaluation outcomes	Four open ended items evaluating COVID-19 impact on participants	end (if applicable), follow-up after 3 months from completion

Collaborators and Investigators

• Sponsor: Valentina Hlebec
• 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
• Investigators: Principal Investigator: Elizabeth J Hanson, PhD Nursing, Linneus University, Kalmar, Sweden

Publications and helpful links

General Publications

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• Merry SN, Hetrick SE, Cox GR, Brudevold-Iversen T, Bir JJ, McDowell H. Psychological and educational interventions for preventing depression in children and adolescents. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD003380. doi: 10.1002/14651858.CD003380.pub3.
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• Greco 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.
• Greco 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.
• 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.
• 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.
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• 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.
• Gettings 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.
• Schlarmann 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.
• 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.
• Joseph S, Becker S, Becker F, Regel S. Assessment of caring and its effects in young people: development of the Multidimensional Assessment of Caring Activities Checklist (MACA-YC18) and the Positive and Negative Outcomes of Caring Questionnaire (PANOC-YC20) for young carers. Child Care Health Dev. 2009 Jul;35(4):510-20. doi: 10.1111/j.1365-2214.2009.00959.x. Epub 2009 Mar 23.
• Joseph S, Kendall C, Toher D, Sempik J, Holland J, Becker S. Young carers in England: Findings from the 2018 BBC survey on the prevalence and nature of caring among young people. Child Care Health Dev. 2019 Jul;45(4):606-612. doi: 10.1111/cch.12674. Epub 2019 May 24.
• 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. Review: Effectiveness of mindfulness in improving mental health symptoms of children and adolescents: a meta-analysis. Child Adolesc Ment Health. 2015 Nov;20(4):182-194. doi: 10.1111/camh.12113. Epub 2015 Sep 8.
• 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.
• Metzing-Blau S, Schnepp W. Young carers in Germany: to live on as normal as possible - a grounded theory study. BMC Nurs. 2008 Dec 24;7:15. doi: 10.1186/1472-6955-7-15.
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• 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.
• Hanson E, Barbabella F, Magnusson L, Brolin R, Svensson M, Yghemonos S, Hlebec V, Bolko I, Boccaletti L, Casu G, Hoefman R, de Boer AH, de Roos S, Santini S, Socci M, D'Amen B, Van Zoest F, de Jong N, Nap HH, de Jong Y, Bouwman T, Lewis F, Parkhouse T, Leu A, Phelps D, Guggiari E, Morgan V, Centola F, Joseph S, Becker S. Research and Innovation for and with Adolescent Young Carers to Influence Policy and Practice-The European Union Funded "ME-WE" Project. Int J Environ Res Public Health. 2022 Aug 11;19(16):9932. doi: 10.3390/ijerph19169932.
• Casu G, Hlebec V, Boccaletti L, Bolko I, Manattini A, Hanson E. Promoting Mental Health and Well-Being among Adolescent Young Carers in Europe: A Randomized Controlled Trial Protocol. Int J Environ Res Public Health. 2021 Feb 19;18(4):2045. doi: 10.3390/ijerph18042045.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): March 20, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Adolescent; Mindfulness; Europe; Acceptance and Commitment Therapy, Cognitive therapy
• Other Study ID Numbers: 754702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized evaluation data to be stored in data archive with limited access.
• IPD Sharing Time Frame: After the completion of the project, but the date is unknown.
• IPD Sharing Access Criteria: not yet known
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No