A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Primary Endpoint
- Mindfulness Skills Acquisition
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
This study will be a single-blinded study (investigators only). Participants will be coded using Arabic numerals. A research assistant will receive all questionnaires and cortisol samples. Mindfulness facilitators will be unaware of participant identification numbers. Participants will be assigned to one of four groups (experimental arm) or to one of two groups (feasibility arm) following a computer-generated randomization list (permuted block design, using blocks of two or four). The allocation sequence will be generated by a statistician not otherwise involved in the project and passed on to a research assistant after patient identification data has been collected (ensuring that the investigators are kept blind to the allocation of each participant). Allocation sequence will be password-protected and only accessible by the statistician and research assistant.
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of chronic illness
- •Fluent in English
- •Followed by a care provider at the Hospital for SickKids
- •Able to consent to the study
- •Able to attend in-person mindfulness meditation sessions at Sickkids (for the experimental arm only)
Exclusion Criteria
- •Active and unaddressed suicidal ideation
- •Developmental disability preventing participation in the mindfulness program
Arms & Interventions
Experimental
The experimental arm will consist of four groups with a target of 15 participants each: one early intervention group, one wait-list in-person group, one early e-Health group and one wait-list e-health group. All participants will receive the mindfulness intervention, MARS-A, either in-person or via e-health by the end of the 6-month study period. Participants in the in-person groups will meet at in hospital at a designated teen-friendly room containing chairs and yoga mats. Participants in the e-health groups will be encouraged to find a quiet room in their home and will be required to have access to the Internet, a desktop/laptop computer equipped with a webcam or a tablet/smartphone with webcam function.
Intervention: MARS-A (Behavioral)
Feasibility
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. The intervention delivered, MARS-A, will be identical as the intervention delivered to e-health groups in the experimental arm.
Intervention: MARS-A (Behavioral)
Outcomes
Primary Outcomes
Mindfulness Skills Acquisition
Time Frame: Up to 6 months
Acquisition of mindfulness skills as measured by the MAAS-A questionnaire a 14-item Likert-type scale that has been validated in adolescents.
Secondary Outcomes
- Anxiety and depression score(Up to 6 months)
- Salivary cortisol levels(Up to 6 months)
- Perception of Illness(Up to 6 months)
- Appreciation of the mindfulness intervention(Up to 6 months)
- Mindfulness home-practice(Up to 6 months)
- Self-Esteem(Up to 6 months)
Investigators
Miriam Kaufman
Division Head, Adolescent Medicine
The Hospital for Sick Children