Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury (SMART)
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|ClinicalTrials.gov Identifier: NCT03498495|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury Traumatic Mild||Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program|
|Actual Study Start Date :||May 12, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||July 15, 2020|
|Experimental: SMART Intervention||
Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)
SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.
|No Intervention: Usual Care|
- Change in Psychological Distress, as measured by the Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: From baseline to 4 weeks post-injury ]The SDQ is a 25-item behavioral screening questionnaire that has adolescents rate their psychological symptoms and positive attributes. The measure has been used with other pediatric-TBI populations89 and provides a measure of functioning across five domains (e.g., prosocial behavior and emotional symptoms). Both youth and their parents will complete, capturing adolescent strengths and challenges on a weekly basis.
- Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form) [ Time Frame: From baseline to 4 weeks post-injury ]The CSI-S is a coping styles measure and has been used with other pediatric TBI samples. Adolescents rate how much they agree with 32-statements regarding different ways of coping with difficult situations on a 5-point Likert scale. Responses are then grouped into primary subscales reflecting eight different coping strategies (e.g., problem-solving, problem avoidance, social withdrawal, etc.).
- Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS) [ Time Frame: From baseline to 4 weeks post-injury ]This 2-item measure will be developed by the research team based on Bandura's self-efficacy theory. Adolescents will rate their level of confidence that they are able to maintain a plan to manage their symptoms each week
- Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: From baseline to 4 weeks post-injury ]The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.
- Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: From baseline to 4 weeks post-injury ]PROMIS collects data from the adolescent participant and the parent about the impact a condition has on the adolescent's functioning.
- Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI) [ Time Frame: From baseline to 4 weeks post-injury ]The HBI is a 20-item questionnaire which includes a variety of cognitive, somatic, emotional, and behavioral symptoms requiring parents and adolescents to rate the frequency of occurrence of each symptom over the past week on a 4-point scale, ranging from "never" to "often."
- Change in concussion knowledge, as measured by the Concussion Questionnaire [ Time Frame: From baseline to 4 weeks post-injury ]The concussion knowledge questionnaire will be based upon the 11-item questionnaire currently being used in the Centers for Disease Control and Prevention Head's Up Concussion Course geared at coaches.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498495
|Contact: Lynn Babcock, M.D.||email@example.com|
|Contact: Shari Wade, Ph.Dfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Lynn Babcock, M.D. 513-250-5188 email@example.com|
|Principal Investigator:||Lynn Babcock, M.D.||Children's Hospital Medical Center, Cincinnati|