TRRP for Traumatic Injury in Adolescents

Overseen By Sarah German, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Self-inflicted injury, Severe injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the TRRP treatment for traumatic injury in adolescents differ from other treatments?

The TRRP treatment, also known as the Trauma Resilience and Recovery Program, is unique because it combines psychological support with enhanced usual care, focusing on building resilience and recovery after trauma. This approach is different from standard treatments that may not integrate psychological resilience-building as a core component. ^{1 2 3 4 5}

Research Team

Tatiana Davidson, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adolescents aged 12-17 who have been admitted to a hospital after a traumatic injury and are showing signs of distress. It's not suitable for those with self-inflicted injuries or severe conditions like head or spinal cord injuries that stop them from communicating.

Inclusion Criteria

I am a teenager aged 12-17 and was admitted to the hospital due to an injury.

Scored significantly on the peritraumatic distress scale (PDI / ITSS)

Exclusion Criteria

I cannot communicate verbally due to severe injuries.

Injury was self-inflicted

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-hospital Education and Risk Reduction

Participants receive in-hospital education, a brief risk reduction session, and tracking of emotional recovery via an automated text-messaging system

1 week

1 visit (in-person)

30-day Screening

Conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment

4 weeks

1 visit (virtual)

Referral and Treatment

Providing referral to best-practice telehealth-based or in-person assessment and treatment

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, and 12 months post-baseline

Treatment Details

Interventions

• Enhanced Usual Care
• TRRP

Trial Overview The study is testing the Trauma Resilience and Recovery Program (TRRP), which uses technology to help improve quality of life and emotional recovery post-injury, against enhanced usual care in pediatric trauma centers.

Participant Groups

Group I: Trauma Resilience and Recovery Program (TRRP) Experimental Treatment 1 Intervention

Enrollment in TRRP which includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) conducting a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to formal mental health services, if needed.

Group II: Enhanced Usual Care Active Control 1 Intervention

Receive brief education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care

Enhanced Usual Care is already approved in United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Children's of Alabama

Collaborator

Trials

10

Recruited

3,000+

Prisma Health-Upstate

Collaborator

Trials

91

Recruited

47,500+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Findings from Research

Tris(2-chloroethyl) phosphate (TRCP) causes significant brain lesions in female F344 rats, which are more severe than in males, while no lesions were observed in B6C3F1 mice, indicating a sex and species-specific toxicity.

Mice eliminate TRCP more rapidly than rats, excreting over 70% of the dose in urine within 8 hours compared to about 40% in rats, suggesting that differences in metabolism may contribute to the observed toxicity differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolism of tris(2-chloroethyl) phosphate in rats and mice. Burka, LT., Sanders, JM., Herr, DW., et al.[2017]

In a study involving both rats and mice, TRCP was found to cause significant toxicity in rats after 16 weeks, including increased liver and kidney weights, and a unique brain lesion in the hippocampus, particularly affecting female rats.

The study suggests that TRCP's specific toxicity to the hippocampus could be useful for further research into its role in behavior and brain function, highlighting a potential mechanism of action for this flame-retardant chemical.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subchronic toxicity studies indicate that tris(2-chloroethyl)phosphate administration results in lesions in the rat hippocampus. Matthews, HB., Dixon, D., Herr, DW., et al.[2017]

In a study of 147 predominantly Black school-aged children with asthma, higher concentrations of di-(2-propylheptyl) phosphate (DPHP) in urine were significantly linked to increased odds of daytime asthma symptoms, indicating a potential impact of this organophosphate ester on respiratory health.

Detection of di-n-butyl phosphate (DBuP) was associated with a higher likelihood of using rescue medication for asthma, suggesting that exposure to certain OPEs may exacerbate asthma symptoms in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposures to Organophosphate Esters and Respiratory Morbidity among School-Aged Children with Asthma. Louis, LM., Buckley, JP., Kuiper, JR., et al.[2023]

A single dose of tris(2-chloroethyl)phosphate (TRCP) significantly increased spontaneous ambulatory activity in male ICR mice, indicating its potential stimulatory effect on movement.

The study suggests that TRCP acts as a GABA antagonist rather than a cholinergic agonist, as its effects on activity were attenuated by GABAergic drugs, highlighting a GABAergic mechanism in its action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tris(2-chloroethyl)phosphate increases ambulatory activity in mice: pharmacological analyses of its neurochemical mechanism. Umezu, T., Yonemoto, J., Soma, Y., et al.[2017]

In a 2-year study involving F344 rats and B6C3F1 mice, chronic exposure to tris(2-chloroethyl)phosphate (TRCP) showed significant toxic effects in the brain and kidneys of rats, with high-dose female rats experiencing degenerative lesions in the brain stem and cerebral cortex.

Unlike previous short-term studies, chronic exposure did not result in hippocampal necrosis in rats, suggesting that the severity of brain lesions may depend on dosage or have different underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity and carcinogenicity of chronic exposure to tris(2-chloroethyl)phosphate. Matthews, HB., Eustis, SL., Haseman, J.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Metabolism of tris(2-chloroethyl) phosphate in rats and mice. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Subchronic toxicity studies indicate that tris(2-chloroethyl)phosphate administration results in lesions in the rat hippocampus. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Exposures to Organophosphate Esters and Respiratory Morbidity among School-Aged Children with Asthma. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Tris(2-chloroethyl)phosphate increases ambulatory activity in mice: pharmacological analyses of its neurochemical mechanism. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Toxicity and carcinogenicity of chronic exposure to tris(2-chloroethyl)phosphate. [2019]