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

NCT04114864 | Completed Phase 1 DMC

• 1 other identifier: 754702
• Study Type: interventional
• Target: 295
• Locations: 6 countries
• Sites: 6

Brief Summary

Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. In Europe, the estimated prevalence rate of YCs is around 4-8%.Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Psychosocial interventions to support YC worldwide are generally quite limited. The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom). The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project. The study aim is to evaluate the efficacy of DNA-V based program for AYCs (so-called ME-WE intervention), using a cluster-randomized controlled trial (C-RCT) design. The evaluation of the intervention will be carried out using as primary outcome variables: Psychological flexibility; Mindfulness skills; Resilience; Subjective mental health; Quality of life; Subjective health complaints; Caring-related quality of life; Cognitive and emotional impact of caring and Social support. As secondary outcome variables will be included Self-reported school, training or work experience, performance, and attendance. COVID-19 Amendment: Recruitment, should be moved to a cluster- based online recruitment or individual, social media recruitment, face-to-face sessions should be moved to online sessions using video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g. ZOOM, Microsoft Teams). Four open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic.

Conditions

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

Keywords

Adolescent; Acceptance and Commitment Therapy, Cognitive therapy; Mindfulness; Europe

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Change from baseline Self-reported school, training or work experience, performance, and attendance at 5 months

  baseline, end (after about 7 weeks), follow up after 3 months from completion

Other Outcomes (5)

• Control variables: 1) Caring activities

  baseline, end (after about 7 weeks), follow up after 3 months from completion

• 2) Overall amount of caring

  baseline, end (after about 7 weeks), follow up after 3 months from completion

• 3) Likes and dislikes about caring

  baseline, end (after about 7 weeks), follow up after 3 months from completion

Study Arms (2)

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

Control

PLACEBO COMPARATOR

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

Behavioral: Psycho-educational sessions

Interventions

Psycho-educational sessions BEHAVIORAL

Participants of clusters allocated to the ME-WE intervention group will complete a programme based on seven weekly sessions of approximately 2 hours each, plus a follow-up meeting after 3 months from the end of the programme. All sessions maintain a similar structure (objectives, ice-breaker, central activity/ies, and final activity). At the end of some sessions, participants will be asked to do some exercises at home, between one meeting and the next one, in order to keep what has been done during the previous session fresh in their minds. Contents of sessions will be as follows: (1) Getting to know each other; (2) The Advisor: dealing with annoying thoughts; (3) The Noticer: being in connection with our feelings; (4) The Discoverer: growing and thriving; (5) Values: connecting to meaning and vitality; (6) Developing a flexible self-view and self-compassion; (7) Building strong social networks.

Also known as: Acceptance and Commitment Therapy - Mental Health- Mindfulness

Control; Experimental

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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)..

Sponsors & Collaborators

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

Study Sites (6)

Anziani e non solo soc. coop. soc

Carpi, Italy

Location

Stichting Vilans

Utrecht, Netherlands

Location

University of Ljubljana

Ljubljana, Slovenia

Location

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

Kalmar, Sweden

Location

Stiftung Kalaidos Fachhochschule (Kalaidos FH)

Zurich, Switzerland

Location

Carers Trust, Print Rooms, 164-180 Union Street, London, SE1 0LN. Carers Trust will be co-ordinating the completion of the interventions for the clinical trials in the UK. All trials for the ME-WE project will be completed in England.

London, United Kingdom

Location

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• 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.

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• 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.

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Study Officials

• Elizabeth J Hanson, PhD Nursing

  Linneus University, Kalmar, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof. dr. Valentina Hlebec; wp6 leader

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: October 3, 2019
• Study Start: October 20, 2019
• Primary Completion: March 20, 2021
• Study Completion: June 30, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the completion of the project, but the date is unknown.
• Access Criteria: not yet known

Locations

IT (1); SL (1); CH (1); SE (1); GB (1); NL (1)