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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Trauma Resilience and Recovery Program (TRRP) can aid teens in recovering better after a serious injury. It compares TRRP to standard care, focusing on enhancing emotional recovery and quality of life. Teens hospitalized due to a sudden, severe injury and experiencing significant distress are ideal candidates. The trial aims to determine if TRRP can be implemented in more hospitals to support teens' emotional and physical recovery. As an unphased trial, it offers teens a unique opportunity to contribute to research that could improve hospital recovery programs.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Trauma Resilience and Recovery Program (TRRP) is generally easy for participants to handle. Since 2015, trauma centers have used TRRP, which includes steps like hospital education, emotional check-ins via text messages, and referrals for mental health services if needed. These steps aim to support emotional recovery after trauma.

Studies of similar programs indicate that this step-by-step approach often leads to good participation and recovery in children. No significant evidence of harmful side effects from this program exists.

The program is in a "Not Applicable" phase, meaning it is not a typical drug trial. This usually focuses more on effectiveness and application rather than safety testing. The Enhanced Usual Care, compared to TRRP, includes education and local referral information. It carries no risks beyond those of standard mental health education practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for traumatic injury in adolescents involve standard care like therapy and medication. However, the Trauma Resilience and Recovery Program (TRRP) is unique because it combines in-hospital education with an innovative follow-up system. It tracks emotional recovery through automated text messages and offers a personalized 30-day screening to identify if further psychological treatment is needed. This tailored and proactive approach helps in early detection and intervention, which researchers believe could significantly enhance recovery outcomes compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for traumatic injury in adolescents?

Research has shown that the Trauma Resilience and Recovery Program (TRRP), a treatment option in this trial, helps teenagers heal emotionally after a traumatic injury. Teens who have participated in TRRP experienced better mental health, improved quality of life, and overall well-being. The program offers education, tracks emotional recovery, and provides access to mental health services if needed. Studies have found TRRP to be both effective and affordable, making it a promising option for helping teens recover. While more information is needed, early signs suggest that TRRP could be a valuable tool in helping adolescents heal both physically and emotionally from traumatic injuries. ^{1 2 3 5 6}

Who Is on the Research Team?

Tatiana Davidson, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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

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

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

Exclusion Criteria

I cannot communicate verbally due to severe injuries.

Injury was self-inflicted

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. nursing.musc.edu nursing.musc.edu/research/funded-projects/evaluation-of-trauma

Evaluation of Trauma Center-Based, Technology ... This study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05086757

Study Details | NCT05086757 | Evaluation of Trauma ... In 2015 the investigators launched the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914157/

Implementation of a Stepped Care Program to Address ... This report describes a quality improvement effort to implement the Trauma Resilience and Recovery Program (TRRP) in 3 Level I and II trauma ...

4. withpower.com withpower.com/trial/phase-wounds-and-injuries-6-2022-75676

TRRP for Traumatic Injury in Adolescents The TRRP treatment, also known as the Trauma Resilience and Recovery Program, is unique because it combines psychological support with enhanced usual care, ...

5. ctv.veeva.com ctv.veeva.com/study/evaluation-of-trauma-center-based-intervention-for-adolescent-traumatic-injury-survivors

Evaluation of Trauma Center-Based Intervention for ... The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9432141/

Addressing Mental Health in Pediatric Trauma Centers - PMC This article describes the engagement and recovery trajectories of pediatric patients enrolled in the Trauma Resilience and Recovery Program (TRRP).