In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
Condition: Chronic Illness; Mental Health Impairment
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      This study will seek to compare the effect of a mindfulness meditation program for
      adolescents with chronic illness delivered either in person or via an online platform. The
      8-week program will combine meditation practices, breathing exercises and group discussions.
      Participants will be recruited from different general and specialized clinics at the Hospital
      for Sick Children and will be allocated to either an in-person or the online group through a
      random process (like tossing a coin). The study will aim to recruit 60 participants ages
      13-18. Each participant will provide data through research questionnaires, recorded
      interviews and saliva samples.
    

Detailed description: 
      The study will be conducted as a longitudinal randomized controlled trial comparing in-person
      and eHealth delivery of a mindfulness meditation intervention for adolescents with chronic
      illness. There will be two arms. An experimental and a feasibility arm. In the experimental
      arm, 4 groups of 10-15 participants will be formed: two in-person groups (early and late) and
      two eHealth groups (early and late). The early groups will receive the intervention at the
      beginning of the study period and the late groups will be wait-list controlled group that
      will receive the intervention at the middle of the study period. At the end of the
      recruitment period or when the target number of participants is met (60), whichever comes
      first, all teens meeting the inclusion criteria will be randomly allocated to one of the four
      randomized groups. Teens who are not meeting the final inclusion criteria (able to attend
      mindfulness sessions at Sickkids) will be offered a spot in the feasibility arm of the study
      until the maximum total number of study participants is reached (60). These participants will
      be placed in eHealth groups (either early or late) through a separate randomization process.

      Data collection will take place at baseline (during the intake meeting), immediately before
      and following the mindfulness intervention as well as at the end of the 6-month study period.
      Participants in the experimental arm will provide data through research questionnaires,
      salivary cortisol analysis as well as individual semi-structured interviews with a research
      assistant. Salivary samples will be provided from home for participants in the eHealth
      groups. Participants in the feasibility arm will only provide information through research
      questionnaires.
    

Intervention name(s): MARS-A
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of the 8-week mindfulness meditation program designed for adolescents with chronic health conditions.MARS-A is based on two established mindfulness-based interventions for adults: MBSR and MBCT. The content of the program will be the same for in-person and e-health groups: all participants will receive eight 90-minute weekly evening sessions led by two trained and experienced mindfulness providers. Sessions will include short meditation practices, breathing exercises, guided discussion, mindful movements and inquiry, adapted to the context of chronic illness. Every session will start with a brief review of home practice and will close with a discussion of the home practice for the following week.
Other intervention name(s): Mindful Awareness and Resiliency Skills for Adolescents
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study will be conducted as a longitudinal randomized non-inferiority trial comparing two arms: an experimental arm and feasibility arm. Participants living close enough to commit to in-person sessions will be entered in the experimental arm of the study. The feasibility arm, which will only take place if the targeted number of study participants (60) is not reached for the experimental arm, will be offered to participants who are not able to commit to the in-person mode of delivery. It will consist of two groups, one early e-health group and one wait-list e-Health group. At the end of the recruitment period, once participants have been placed in the experimental and feasibility arms, two separate randomizations will take place. The first randomization (experimental arm) will serve to assign participants to one of the four experimental groups and the second randomization (feasibility arm) will assign participants to one of the two feasibility groups.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: mindfulness meditation; Adolescent; eHealth; randomized trial