Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 516950 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| Montreal Children's Hospital of the MUHC | OTHER |
| University of Ottawa | OTHER |
| British Columbia Children's Hospital |
Not provided
Not provided
Not provided
Not provided
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.
The proposed study has two groups: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) control group: usual care plus early introduction sham application, including the cognitive math game called 2048. Usual care in both groups refers to the recommended return to physical and cognitive activity 24-48 hours post-injury. To maintain valid results, participants will be "blinded" to their intervention. (i.e., during the informed consent process, the study will be referred to as the App-based Intervention study with the purpose of evaluating two app-based interventions). Although only one group will receive the MBI intervention, both groups will be receiving usual care instructions, which involves the early return to cognitive and physical activities. Therefore, both groups will be receiving a beneficial intervention with the experimental group receiving the additional MBI that is being assessed. For both groups, Treatment Coaches will be assigned to each participant. Coaches will maintain regular communication with patients. Their role will be to encourage and assist participants throughout the study duration through a standardized question-and-answer protocol. Additionally, to increase adherence to the intervention, participants will complete a motivational interview at 2 weeks. After 4 weeks, all participants will be offered the MBI program for an extra period of 4 weeks. The control group will have the possibility at that time to crossover and start the intervention if desired.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Intervention + Usual Care | Experimental | Experimental group: MBI training will consist of a 4-week custom-made program that includes setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal. Each standardized course will be unlocked as the participant progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks (with the option to continue for 8 weeks). |
|
| Cognitive Sham + Usual care | Sham Comparator | Usual care recommends that patients refrain from physical and cognitive activities for 24-48 hours after concussion. After the initial rest period, it is recommended to introduce low to moderate levels of physical and cognitive activity at a level that does not result in recurrence or exacerbation of symptoms. Patients must refrain from any activities that increase the risk of re-injury (body contact or risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. This arm is considered as active participant with the sham app (cognitive math game called "2048") delivered via the same app as the MBI, but without the mindfulness content. Participants will be encouraged to engage in the app-based activities for at least 10 minutes daily, with a minimum of 4 days per week, over a period of 4 weeks. Participants will also be asked questions about their stress, emotions, and symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Intervention (MBI) | Behavioral | Using the Dawn MBI-based app, targeted MBI training will consist of a 4-to-8-week custom-made program that includes audio-recorded lectures, guided meditations such as walking meditations and body scans, setting intentions and check-in with mood, and writing events journal. Each standardized course is unlocked as the participant progresses through the MBI program. Participants will be encouraged to engage in the app-based activities for at least 10 minutes every day, with a minimum of 4 days per week, over a period of 4 weeks (with option to continue for 8 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Quality of Life Inventory™ version 4.0 | The PedsQL is a reliable and valid measure of quality of life (QoL) in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. The inventory covers four domains: physical, emotional, social, and school, the sum of which is total QoL. This measure will be used to assess whether early brief MBI can improve total QoL. Higher scores indicate better health related to QoL. | Day of enrolment (ED), Week 4, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Connor-Davidson Resilience Scale-10 (CD-RISC) | A Validated measure offered in both English and French for the adolescent concussion population that assesses the individual's own perception of hardiness or perceived stress. It is a 10-item rating scale, 5-point Likert scale; the scale is summed and provides a total score (0-40) for the level of resilience. A lower score is attributed to lesser levels of resilience. |
| Measure | Description | Time Frame |
|---|---|---|
| Self assessments | Upon entering the app, participants will be asked daily to self-asses their mood and levels of stress. Self-assessed stress is captured via a visual-point scale and self-assessed emotions are captured via participant selecting their emotions. There is also a daily thought journal included within the app. requiring participants to journal their thoughts in the moment daily and write their positive thoughts. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrée-Anne Ledoux, PhD | Contact | +1 613-737-7600 | 4104 | aledoux@cheo.on.ca |
| Tyrus Crawford | Contact | +1 613-737-7600 | tcrawford@cheo.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Andrée-Anne Ledoux, PhD | Children's Hospital of Eastern Ontario Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Edmonton | Ontario | T6G 2B7 | Canada |
We plan to share the study protocol and statistical analysis plan.
These documents will be shared once the protocol is published
The protocol will be accessible online and through Trial.gov
Not provided
Not provided
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| OTHER |
| Stollery Children's Hospital | OTHER |
Pragmatic-blind randomized clinical trial with two two groups who will be studied: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) a delayed-start (crossover) control group: usual care plus early introduction sham application, including the cognitive math game called 2048, with option to receive experimental app-based MBI after 4 weeks.
Not provided
Not provided
Pragmatic-blinding
|
|
| Cognitive Sham | Behavioral | Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. The sham journey will consist of playing an open-source cognitive math game (called "2048") delivered through the same app as MBI, but without the mindfulness content. Participants will be encouraged to utilize the app for at least 10 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks. |
|
|
| Day 1, Week 4, & Week 8 |
| The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS) | Designed to measure fatigue in pediatric patients and comprises the General Fatigue Scale (6 items), Sleep-Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). The PedsQL™ Multidimensional Fatigue Scale has demonstrated excellent internal consistency, reliability and validity. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. Higher scores are associated with less fatigue. | Day 1, Week 4, & Week 8 |
| Health and Behaviour Inventory (HBI) | This assessment will be used to measure the degree of symptoms, available in both English and French. The HBI is a 20-item self-report questionnaire, Likert scale (0, 1, 2, or 3 points) yielding separate scores for cognitive and somatic symptom scales for a total score range of 0 to 60. Higher scores indicate a higher degree of symptoms. Participants will complete a post-injury measure, while parents will complete a retrospective (pre-injury) measure at an emergency department presentation. Only participants will complete HBI measures at follow-up. | Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8 |
| The General Anxiety Disorder 7-items (GAD-7) | The GAD-7 is a validated, reliable and sensitive to treatment-related changes tool that assesses anxiety symptoms in youth. It is a 7-item scale, 3-point Likert scale, providing a sum score (0-21) of the level of GAD. A higher score indicates a worse outcome. It is available for participants in both English and French. | Day of enrolment (ED), Week 4, & Week 8 |
| Center for Epidemiologic Studies Short Depression Scale (CES-D-10) | The CES-D-10 is a 10-item questionnaire assessing how individuals feel during the past week. This is a short version of the 20-item CES-D tool. Graded on a 4-point Likert scale, with items 5 and 8 scored inversely. The final score is the sum of the graded items with higher scores indicating a worse outcome. The CES-D-10 has good internal consistency (Cronbach's α=0.86) and test-retest reliability (I CC=0.85). It is also available in both English and French. | Day of enrollment (ED), Week 4, & Week 8 |
| Child and Adolescent Mindfulness Measure (CAMM) | The CAMM is a 10-item validated self-report measure of mindfulness for use with children and adolescents, in both English and French. Responses are scored on a 5-point Likert scale. Lower scores indicate higher tendencies to be mindful in everyday life. | Day 1, Week 4, & Week 8 |
| Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI) | The Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI) is a validated measure used in the pediatric population with concussion to measure the degree of fear avoidance as a negative coping style post-injury. It is comprised of 16-item, 4-point Likert scale asking participants to agree with statements that range from 0 ("strongly disagree") through 3 ("strongly agree"). The total item score is out of 48 with higher scores associated with more negative clinical outcomes.(Cairncross et al., 2021). This measure is offered in both English and French. | Week 4 & Week 8 |
| Avoidance and Fusion Questionnaire for Youth Short Form (AFQ-Y8) | The AFQ-Y8 is the 8-item short-form version of the original 17-item AFQ-Y, a self-report measure examining psychological inflexibility in youth. This validated measure comprises two constructs of psychological inflexibility: cognitive fusion (the belief that inner thoughts are true and allow them to dominate behaviour) and experiential avoidance (avoidance or suppression of unwanted internal experiences). Participants are asked to agree with statements on a 5-point Likert scale with responsed from not true at all (0) to very true (4). Items are summed to produce a final score between 0 and 32, with a higher score indicating greater psychological inflexibility. Measures are available in both English and French. | Day 1, Week 4 & Week 8 |
| Perceived Stress Scale (PSS-10) | A 10-item self-report questionnaire examining an individual's perception of stress. The items are ranked on a 5-point Likert scale, asking participants to respond from Never (1) to very often (5). Items 4, 5 and 7 are positively worded and reverse-scored, then all items are summed. Higher scores indicate that participants are more likely to appraise events as stressful. Participants also have the option to complete the measure in English or French. | Day of enrollment (ED), Week 4, & Week 8 |
| Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) | A validated 10-item questionnaire used in adolescent populations to measure emotion regulation. The measure consists of 2 subcategories: cognitive reappraisal (6 items) and expressive suppression (4 items). . Responses to items include a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Composite scores for cognitive reappraisal range from 6-30 and 4 to 20 for expressive suppression. Scores are typically interpreted separately. Higher reappraisal scores are associated with positive tendencies to reframe situations to regulate emotions, while higher repressive scores are negatively associated with the tendency to inhibit emotions. This measure can be completed in English of French. | Day 1, Week 4, & Week 8 |
| Credibility Score (Credibility and Expectancy Questionnaire (CEQ)) | The CEQ is a 6-item questionnaire (9-point Likert scale) assessing credibility and expectancy. The validated questionnaire demonstrates excellent reliability across different populations and is available in both English and French. A higher score indicates more credibility. | Week 1 |
| Modified version of the Client Satisfaction Questionnaire (CSQ) | This is a validated, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or service. In this case, the questionnaire has been modified to assess participant satisfaction with the app-based intervention. It is available to participants in English or French. | Week 4 |
| Daily through study completion, on average 8 weeks. |
| Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTAQ) | The GSLTAQ was developed to classify physical activities/exercises performed into three subgroups: strenuous, moderate, and light. The frequency and type of activity/exercise score performed over the past week are used to calculate the physical activity/exercise total score. A higher score corresponds to a higher level of weekly activity/exercise. | Week 1, Week 2, Week 4, Week 8 |
| Puberty Questionnaire | The questionnaire is a 5 question, self-administered rating scale for pubertal development without pictorial representations or interviews. Separate forms are used for boys and girls. For Items 1 through 4 on the girls' version and all items on the boys' version, response options are: not yet start (1 point); barely started (2 points); definitely started (3 points); seems complete (4 points); I don't know. Yes, on the menstruation item for girls is 4 points, while No is 1 point. Points are then averaged for all items to give a Pubertal Developmental Scale. Pubertal Category Scores can also be computed. | Day of enrollment (ED) |
| Return to school and physical activity questions | Participants will be asked if or when they returned to a full day of school, and if or when they have returned to usual levels of physical activity. These questions will be asked at follow-up each week after enrolment | Week 1, Week 2, Week 4, Week 8 |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
|
| The Hospital of Sick Children (SickKids) | Toronto | Ontario | M5G 1X8 | Canada |
|
| BC Children's Hospital | Vancouver | Ontario | V6H 3N1 | Canada |
|
| Montreal Children's Hospital | Montreal | H4A3H9 | Canada |
|
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |