In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03067207
Study type	Interventional
Source	The Hospital for Sick Children
Contact
Status	Completed
Phase	N/A
Start date	November 4, 2016
Completion date	June 15, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms