Rehabilitation, Education, and SElf-management for Adolescents After Mild Traumatic Brain Injury

ConditionsBrain Concussion Mild Traumatic Brain Injury Concussion

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-18

SponsorMolly Cairncross

About this trial

Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 12-18

Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition

Concussion/mTBI occurred 1-12 months prior to randomization

Persisting symptoms after concussion as demonstrated by a score >75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group

Disqualifiers

Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis)

Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., <2 weeks post-injury).

Trial design

Design model

Parallel

Treatments tested in this trial

Mindfulness-based intervention
Behavioral
The mindfulness-based intervention (MBI) is delivered via a smartphone application called Dawn. The MBI consists of 8-week MBI program developed to meet the needs of adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and guided mindfulness exercises. The goal of this intervention is to support better coping with symptoms.
Health Education
Behavioral
The health education program is delivered via a smartphone application called Dawn. It is an 8-week program designed to deliver information about health behaviors (e.g., sleep, exercise, nutrition, social support) that is inline with clinical practice guidelines for adolescents post-concussion/mTBI. The intervention includes audio-recorded psychoeducation and health behavior tracking exercises. The goal of this intervention is to provide a credible, time- and attention-matched control group.

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: Mindfulness-based interventionExperimental treatment 1 intervention

Group B: Health educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Eligibility

% screened that are eligible

Time frame

pre-enrollment

Recruitment rate

% eligible participants randomized

Time frame

at randomization

Treatment Adherence

% participants who complete 70% of the intervention

Time frame

post-intervention questionnaires (Week 8)

Retention

% participants who complete follow-up assessment

Time frame

post-intervention questionnaires (Week 8)

Secondary outcomes

Treatment credibility and expectancy

Proportion of participants who view the treatment as logical (credibility) and expect that it will help (expectancy) will be measured by the Credibility Expectancy Questionnaire. Scores range from 6-64 with higher scores reflecting higher treatment credibility and expectancy. A score above the midpoint will be considered acceptable.

Time frame

7-14 days post-enrollment

Treatment Satisfaction

This Client Satisfaction Questionnaire is a validated, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or services (range 8-32). Higher scores reflect better treatment satisfaction. A score above the scale midpoint on the Client Satisfaction Questionnaire will be considered acceptable.

Time frame

Post-intervention questionnaires (Week 8)

Other outcomes

Pediatric Quality of Life Inventory

The Pediatric Quality of Life Inventory (Peds-QL) will be the primary clinical endpoint for a future efficacy trial. The total scale will be used. Scores ranged from 0-100, with higher scores reflecting better health-related quality of life.

Time frame

pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

Mild Traumatic Brain Injury Symptom Burden

The Health and Behaviour Inventory (HBI) is a 20-item self- report questionnaire of post-concussion symptoms. We will calculate a total score by summing all items. The score ranges from 0-60, with higher scores reflecting higher symptom burden.

Time frame

pre-randomization (week 0), mid-intervention (week 4), and post-intervention (week 8)

Anxiety

The Patient-Reported Outcomes Measurement Information System Pediatric Anxiety Short For 8a is a validated, reliable and sensitive to treatment-related changes tool that assesses anxiety symptoms in youth. T-scores will be calculated, with higher scores reflecting higher anxiety.

Time frame

pre-randomization (week 0) and post-intervention (week 8)

Depression

The Patient-Reported Outcomes Measurement Information System Pediatric Depressive Symptoms Short Form 8a will be used to asses depression. It is a validated, reliable and sensitive to treatment-related changes tool that assesses depression symptoms in youth. T-scores will be calculated, with higher scores reflecting higher depression

Time frame

pre-randomization (week 0) and post-intervention (week 8)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Molly Cairncross

Lead sponsor

Simon Fraser University

Sponsor institution

Source ClinicalTrials.gov

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