Concussion, Brain Clinical Trial
— CHIPOfficial title:
Optimizing Collaborative Care for Youth With Persistent Post-Concussive Symptoms
More than 1 million U.S. youth sustain a concussion each year, and up to 30% report persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can interfere with normal adolescent development, resulting in issues with socioemotional dysfunction and even school failure. However, few evidence based treatments are available for youth with PPCS. The investigators conducted extensive work adapting a collaborative care framework for youth with PPCS, combining concussion-focused cognitive behavioral therapy (cf-CBT), parent skills training (PST) and care management (CM) to create a wraparound treatment for youth with PPCS that can be delivered either in-person or virtually. They completed an R01-funded randomized controlled trial with this approach, finding effectiveness for youth with PPCS, with improvements in concussive symptoms and quality of life at one year, and 60% of participants completing the intervention entirely virtually. Of note, this intervention is unique in that two of the components are focused on parents or parents and youth together (PST, CM), and only one of the components (cf-CBT) is solely youth focused. The investigators now propose to optimize and refine this approach, conducting a high efficiency MOST (multiphase optimization strategy) trial to assess the contribution of each of the three components (cf-CBT, PST and CM) to effectiveness, thereby enabling streamlining of the intervention to only include active components. The analysis will be factorial, with three intervention components and two levels of each (present or absent), resulting in 8 treatment pathways. The benefit of the MOST approach is that it combines all youth who receive a component, allowing assessment of all treatment components with only a modest sample size. The study will recruit 374 youth with PPCS, randomizing them to one of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over three months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood and parental distress) at 6 weeks, and 3, 6 and 12 months. Potential mediators and moderators will also be assessed to allow for future tailoring and refinement. At the completion of this study, the investigators will have generated a completely optimized and refined intervention for youth with PPCS ready for large scale implementation and dissemination.
Status | Recruiting |
Enrollment | 374 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 18 Years |
Eligibility | Inclusion Criteria: - 11-18 years old - Health care provider diagnosed concussion within 1-12 months = 3 new onset or worsening post-concussive symptoms (measured with the HBI) - Can be located anywhere as study is all completed remotely Exclusion Criteria: - Active suicidal ideation, diagnosis of psychosis or psychiatric hospitalization within 6 months - Spinal cord injury or other severe injury or illness that might impede participation - Youth or parent not fluent in Spanish or English - Chronic illness or medical conditions that prevent participation in concussion-focused treatment |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern (UTSW) | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center, University of Washington |
United States,
McCarty CA, Zatzick D, Stein E, Wang J, Hilt R, Rivara FP; Seattle Sports Concussion Research Collaborative. Collaborative Care for Adolescents With Persistent Postconcussive Symptoms: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20160459. doi: 10.1542/peds.2016-0459. Epub 2016 Sep 13. — View Citation
McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, Hilt R, Jinguji T, Quitiquit C, Chrisman SPD, Rivara FP. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210207. doi: 10.1001/jamanetworkopen.2021.0207. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parent-Patient Activation Measure (P-PAM) | The 10-item P-PAM will be used to assess parenting self-efficacy in advocacy within the health care system (knowledge, skills, and confidence for managing their child's health care).22 The 4-point scale ranges from "disagree strongly" to "agree strongly" (e.g., "I am confident I can tell a doctor concerns I have about my child's health"). (Mediator for CM) Possible scores range from 10-40 with higher scores indicating greater confidence (i.e., better). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Other | Generalized self-efficacy (GSE) | This 10-item scale measures general self-efficacy on a scale of 1 (not at all true) to 4 (exactly true) on items such as "I can usually handle whatever comes my way," with higher scores indicating greater self-efficacy. Youth will provide self-report on this measure.(Mediator for cf-CBT) Possible scores range from 10-40 with higher scores indicating greater self-efficacy. | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Other | Adult responses to child's symptoms (ARCS) | Measure of protective parenting responses to child symptoms (Goal is decreased, Mediator for PST). We are only using the protective parenting subscale, which is 17 items, each encoded 0-4. Possible scores range from 0-68 with higher indicating more protective parenting (i.e., worse). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Primary | Health Behavior Inventory (HBI) | A 20-item questionnaire that assesses concussive symptoms on a 4-point scale, ranging from "never" to "often," and yields total scores in cognitive and somatic domains. The scale includes youth-report and parent-report versions with established reliability and validity in youth with sports-injury. Possible scores range from 0-60 with higher indicating more symptomatic (i.e., worse). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Primary | Pediatric Quality of Life Inventory (PedsQL) | A 23-item questionnaire that assesses physical, emotional, social and school functioning. The scale includes youth-report and parent-report versions. Possible scores range from 0- 100 with 100 indicating higher quality of life (i.e., better). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Secondary | Generalized Anxiety Disorder-7 item (GAD-7) | A 7-item measure of youth anxiety symptoms during the prior two weeks on a 4-point scale.Possible scores range from 0-21 with higher indicating more symptomatic (i.e., worse). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Secondary | Patient Health Questionnaire-9 item (PHQ-9) | A 9-item questionnaire that measures severity of depressive symptoms. Reliability and validity of the PHQ-9 have been established in pediatric populations with injury. Possible scores range from 0-27 with higher indicating more symptomatic (i.e., worse). | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Secondary | Adolescent Sleep Wake Scale-10 item (ASWS-10) | A measure of sleep quality including domains of falling asleep, reinitiating sleep and returning to wakefulness. For scoring several items are reversed and then an average score is calculated. Possible scores range from 1-6 with higher indicating better sleep quality. | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Secondary | Pediatric Inventory for Parents (PIP) | 15 item scale measuring parent distress regarding their child's illness, each on a scale of 1-5. Possible scores range from 15-75 with higher scores indicating increased emotional distress. | Trajectory over one year (baseline, 6 weeks, 3 months, 6 months, 1 year) | |
Secondary | Headache daily diary | 7 day diary measuring headache occurrence and severity (0-10) daily. Completing these measures will provide two scores, each 0-10 with higher numbers indicating worse symptoms. | Trajectory over one year (baseline, 3 months, 6 months, 1 year) | |
Secondary | Mood daily diary | 7 day diary measuring mood valence (0= very negative to 10= very positive) and energy. level (0=very low energy to 10= very high energy level). Completing these times will result in two scores, each 0-10. For mood valence, lower numbers will indicate more negative mood (i.e., worse). For energy level, lower numbers will indicate lower energy (defined as worse or better dependent on the valence of the mood it refers to). | Trajectory over one year (baseline, 3 months, 6 months, 1 year) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04109677 -
AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
|
||
Recruiting |
NCT04932278 -
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
|
N/A | |
Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
Recruiting |
NCT05682677 -
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
|
N/A | |
Recruiting |
NCT04992130 -
Sport Concussion Performance-Based Prevention Program
|
N/A | |
Completed |
NCT05095012 -
RECOVER Clinical Pathway for Pediatric Concussion
|
N/A | |
Recruiting |
NCT05886400 -
The Effects of Environmental Distractions on SCAT6 Outcomes
|
N/A | |
Active, not recruiting |
NCT05400551 -
Craneofacial Injuries in Rink Hockey Athletes
|
||
Recruiting |
NCT04121780 -
Growth Hormone Replacement Therapy for Retried Professional Football Players
|
Phase 2 | |
Withdrawn |
NCT03575741 -
Postural Control in Children and Adolescents After Suffering From a Concussion
|
||
Active, not recruiting |
NCT05471791 -
Development of a Concussion Management Platform for Children and Youth
|
N/A | |
Completed |
NCT04730167 -
The Monaco Initiative for Concussion in Motorsport Pilots
|
||
Completed |
NCT03478059 -
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
|
N/A | |
Recruiting |
NCT05685121 -
A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents
|
N/A | |
Completed |
NCT04122274 -
Comparing and Interactive Concussion Education Platform to Current Education Standards
|
N/A | |
Completed |
NCT04558346 -
Ghrelin (OXE--103) for Acute Concussion Management
|
Phase 2 | |
Completed |
NCT04074486 -
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
|
||
Not yet recruiting |
NCT05562232 -
The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms
|
N/A | |
Recruiting |
NCT05326555 -
Dynamic Vision Testing and Concussion Management Dream Team 65
|
||
Completed |
NCT03170856 -
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
|
N/A |