Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

Official title

Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)

Overview

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.

Detailed description

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.

Interventions

• Behavioral Mindfulness Based Intervention (MBI)
  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
• Behavioral Cognitive Sham
  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)

Primary outcome measures

• Pediatric Quality of Life Inventory™ version 4.0 [Time frame: Day of enrolment (ED), Week 4, Week 8]

Secondary outcome measures (12)

• Connor-Davidson Resilience Scale-10 (CD-RISC) [Time frame: Day 1, Week 4, & Week 8]
• The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS) [Time frame: Day 1, Week 4, & Week 8]
• Health and Behaviour Inventory (HBI) [Time frame: Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8]
• The General Anxiety Disorder 7-items (GAD-7) [Time frame: Day of enrolment (ED), Week 4, & Week 8]
• Center for Epidemiologic Studies Short Depression Scale (CES-D-10) [Time frame: Day of enrollment (ED), Week 4, & Week 8]
• Child and Adolescent Mindfulness Measure (CAMM) [Time frame: Day 1, Week 4, & Week 8]
• Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI) [Time frame: Week 4 & Week 8]
• Avoidance and Fusion Questionnaire for Youth Short Form (AFQ-Y8) [Time frame: Day 1, Week 4 & Week 8]
• Perceived Stress Scale (PSS-10) [Time frame: Day of enrollment (ED), Week 4, & Week 8]
• Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) [Time frame: Day 1, Week 4, & Week 8]
• Credibility Score (Credibility and Expectancy Questionnaire (CEQ)) [Time frame: Week 1]
• Modified version of the Client Satisfaction Questionnaire (CSQ) [Time frame: Week 4]

Eligibility criteria

Inclusion criteria

• 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
• Suffered the index injury in the previous 48 hours
• Proficient in English or French

Exclusion criteria

• 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)
• Severe neurological developmental delay resulting in communication difficulties
• Intellectual disability/mental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)
• Intoxication at the time of ED presentation as per clinician judgment
• No clear history of trauma as primary events (e.g., seizure, syncope or migraine)
• Prior psychiatric hospitalization
• Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)
• Inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)
• Legal guardian not present (certain forms need be completed by parents/legal guardians)
• No internet or mobile/tablet access.
• Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Canada · 5 centers

• Stollery Children's Hospital — Edmonton
• Children's Hospital of Eastern Ontario — Ottawa
• The Hospital of Sick Children (SickKids) — Toronto
• BC Children's Hospital — Vancouver
• Montreal Children's Hospital — Montreal

Identifiers

NCT: NCT07272941 · 516950 · 516950

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗