Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital of Eastern Ontario
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants presenting to five PERC EDs after sustaining a direct or indirect head injury
Aged 12 through 17.99 years
Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition
Score ≥6 on the 5P rule
Disqualifiers
Glasgow Coma Scale ≤13
Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)
Neurosurgical operative intervention, intubation or intensive care required
Multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Based Intervention (MBI)
BehavioralUsing 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).
Cognitive Sham
BehavioralUsual 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.
Treatment groups
362 Participants
are divided into 2 treatment groupsGroup A: Mindfulness Intervention + Usual CareExperimental treatment 1 intervention
Group B: Cognitive Sham + Usual careSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day of enrolment (ED), Week 4, Week 8Secondary outcomes
1
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.
Time frame
Day 1, Week 4, & Week 82
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.
Time frame
Day 1, Week 4, & Week 83
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.
Time frame
Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 84
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.
Time frame
Day of enrolment (ED), Week 4, & Week 8Other outcomes
1
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.
Time frame
Daily through study completion, on average 8 weeks.2
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.
Time frame
Week 1, Week 2, Week 4, Week 83
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.
Time frame
Day of enrollment (ED)4
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
Time frame
Week 1, Week 2, Week 4, Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Eastern Ontario
Lead sponsor
The Hospital for Sick Children
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
University of Ottawa
Collaborator
British Columbia Children's Hospital
Collaborator
Stollery Children's Hospital
Collaborator
Source ClinicalTrials.gov
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