Positive Assurance and mTBI

NCT04982731 | Enrolling By Invitation

• 1 other identifier: U20-05-4050
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop and validate a new educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

Conditions

MTBI - Mild Traumatic Brain Injury; Concussion, Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Behavioral Regulation Assessment for Concussion (BRAC)

  The Behavioral Regulation Assessment for Concussion (BRAC) is a five-item, four-point Likert scale (with values ranging from '0-Never' to '5-Most of the Time') assessment for the frequency of self-reported behavioral regulation behaviors that occurred during the past seven days. Scores range from 0 to 20, with higher scores indicating a better outcome. Likert scale scores are reported for each item, with a higher score indicating greater frequency. An average score for the BRAC is the average of all the scores across the items.

  Gathered at Baseline Visit

• Expectations of Recovery Scale

  The Expectations of Recovery Scale will be used to measure the effect of positive assurance on recovery. This is a seven-item scale that asks individuals to assess whether they think they will get better soon, return to usual activities/work within the next month, return to the pre-injury performance and to consider what they had been told about their injury and what those closest to them advised. Items within this scale are scored independently of each other, therefore neither higher nor lower scores indicate a better or worse outcome.

  Gathered at Baseline Visit

Secondary Outcomes (4)

• State-Trait Anxiety Inventory (STAI)

  Gathered at Baseline Visit and through study completion, an average of one month

• mTBI Symptoms

  Gathered at Baseline Visit and through study completion, an average of one month

• Immediate Post-concussion Assessment and Cognitive Test (ImPACT)

  Gathered at Baseline Visit and through study completion, an average of one month

• Vestibular/Ocular Motor Screening (VOMS)

  Gathered at Baseline Visit and through study completion

Study Arms (2)

Positive Assurance Discharge Video Educational Intervention (EDUC).

EXPERIMENTAL

The video intervention will be administered to participants that are randomly assigned to the EDUC group. In addition, current standard of care discharge instructions will also be provided to the participant. This EDUC intervention will consist of a brief, three to five-minute informative video message from the clinical neuropsychologist at the Inova Sports Medicine Concussion Program. Participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.

Other: Positive Assurance

Standard of Care Instructions (Treatment as Usual: TAU )

NO INTERVENTION

The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites is the standard-of-care discharge instruction for individuals with mTBI. This care plan provides patient and caregiver education about mTBI and emphasizes the monitoring of symptoms, signs of deterioration that may warrant urgent medical attention, and encourages the patient to follow up with their physician for follow up. Participants who are randomized into the TAU group will receive this standard of care treatment in video format, however these participants will not be given a QR code to watch the intervention video.

Interventions

Positive Assurance OTHER

Positive assurance is a low-cost, non-pharmacological strategy commonly used by specialty clinics to manage anxiety in individuals with mTBI. Positive assurance is comprised of words of affirmation given to individuals with a medical condition by a healthcare provider that are centered on hope and positive recovery expectations (i.e., "You will recover," "This can be treated").

Positive Assurance Discharge Video Educational Intervention (EDUC).

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects must meet the following criteria in order to be eligible to participate:
• years
• Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)
• Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova-GoHealth Urgent Care clinic within 72 hours of injury
• Is able to provide remote informed written consent (parent) and assent

You may not qualify if:

• Subjects who meet any of the following criteria will not be eligible to participate:
• Loss of consciousness \> 30 minutes in conjunction with the injury
• Glasgow Coma Scale (GCS) score \< 13
• Has sustained a previous mTBI within the past 6 months
• Has a neurological disorder (e.g., epilepsy)
• Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
• Has a previous history of neurosurgery
• Does not speak English as a primary language
• Requires admission to the hospital
• Has developmental delays
• Prisoner
• Pregnant\*
• Has been previously enrolled in the study
• Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
• COHORT 2:

Sponsors & Collaborators

• Inova Health Care Services: lead
• University of Arkansas, Fayetteville: collaborator

Study Sites (1)

Inova Health System

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: July 29, 2021
• Study Start: October 15, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)