Ready4Life Program for Young People

Overseen By McKenna C LeClear, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Evaluation & Research

Disqualifiers: Over 18, Not in high school, Others

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

Compensation: Varies

Number of Visits: 1

1680 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the Imperial Valley Regional Occupational Program (IVROP) ReadyforLIFE program evaluation is to determine whether primary (i.e., behaviors) and secondary (i.e., attitudes) outcomes improve for youth participants after completing the ReadyforLIFE program. Understanding the ways in which the IVROP ReadyforLIFE program supports healthy partner relationships and economic stability is important for those providing services to at-risk youth populations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ReadyforLIFE Program treatment?

The effectiveness of the ReadyforLIFE Program may be supported by similar enhanced recovery programs (ERPs) used in surgery, which have shown to reduce hospital stays, decrease complications, and improve patient satisfaction by engaging patients and families in the recovery process. ^{1 2 3 4 5}

Is the Ready4Life Program safe for young people?

There is no specific safety data available for the Ready4Life Program itself, but general safety practices in youth training interventions emphasize the importance of monitoring for any adverse events (unintended, potentially harmful events). This suggests that safety monitoring is a key part of ensuring the program is safe for participants. ^{6 7 8 9 10}

How does the Ready4Life Program treatment differ from other treatments for young people?

The Ready4Life Program is unique because it focuses on developing life skills in young people through immersive, real-world experiences, which is different from traditional treatments that may not emphasize experiential learning and empowerment. This approach is similar to the Residential Immersive Life Skills (RILS) programs, which have shown transformative effects on youth by providing opportunities to develop critical life skills away from home. ^{11 12 13 14 15}

Research Team

Matt D Shepherd, PhD

Principal Investigator

Midwest Evaluation & Research

Eligibility Criteria

This trial is for high school-aged youth living in Imperial Valley, CA who are considered at-risk due to factors like being foster or justice-involved, part of an immigrant household, undocumented status, or identifying as LGBTQ. It's not open to those over 18 or out of high school and non-residents of Imperial Valley.

Inclusion Criteria

I am of high school age.

Residing in the Imperial Valley, CA

At-risk youth (foster/justice involved, immigrant household, undocumented, LGBTQ)

Exclusion Criteria

Individuals who reside outside of Imperial Valley, CA

I am over 18 years old and have finished high school.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Enrollment

Participants enroll in the IVROP ReadyforLIFE program and begin data collection

1 week

1 visit (in-person)

Program Participation

Participants receive workshops and support services, including 12 hours of Relationships Smarts Plus, 3 hours of Mind Matters, and 1 hour of Money Habitudes over 6 weeks

4 weeks to 1 year

Follow-up

Participants are monitored for changes in behavior and attitudes related to healthy relationships and financial stability

12 months

Treatment Details

Interventions

• ReadyforLIFE Program

Trial Overview The IVROP ReadyforLIFE program aims to improve behaviors and attitudes among young people that support healthy relationships and economic stability. The evaluation will assess the effectiveness of primary services provided by the program.

Participant Groups

Group I: Primary Services Experimental Treatment 1 Intervention

Primary services: Participants receive 12 hours of Relationships Smarts Plus, 3 hours of Mind Matters and 1 hour of Money Habitudes workshops over the course of 6 weeks. Participants also receive life coaching and on-going job readiness support.

Who Is Running the Clinical Trial?

Midwest Evaluation & Research

Lead Sponsor

Trials

11

Recruited

11,700+

Imperial Valley Regional Occupational Program (IVROP)

Collaborator

Trials

1

Recruited

1,700+

Findings from Research

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

The safety profile of a drug post-registration is primarily informed by spontaneous reports from healthcare professionals, highlighting the importance of ongoing monitoring after a drug is approved.

This article focuses on analyzing adverse drug reactions reported to the Regional Centre of Monitoring Adverse Drug Reactions in Poznań, emphasizing the need for systematic evaluation of these reports to ensure drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. Jabłecka, A., Korzeniowska, K.[2013]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

The Aggregate Safety Assessment Plan (ASAP) is designed to enhance safety planning and ongoing data review throughout a drug's life-cycle, promoting a systematic approach to understanding product safety.

By implementing the ASAP process, drug developers can improve early detection of safety signals, better characterize risks, and ensure consistent safety messaging across studies, ultimately aiding in informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. Hendrickson, BA., Wang, W., Ball, G., et al.[2021]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

This 5-year prospective study will evaluate the long-term benefits of Residential Immersive Life Skills (RILS) programs for youth with disabilities, involving 30 participants aged 14-21 each year across three sites in Ontario, Canada.

The study aims to identify key features and experiences that contribute to the success of RILS programs, addressing gaps in understanding how immersive environments can positively influence self-determination and self-efficacy in young people with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing life success through residential immersive life skills programs for youth with disabilities: study protocol of a mixed-methods, prospective, comparative cohort study. McPherson, AC., King, G., Rudzik, A., et al.[2018]

References

1. France pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery in pediatric orthopedics (ERAS-PO). [2020]

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

Enhanced Recovery Program for Outpatient Female Pelvic Reconstructive Surgery. [2022]

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

Patient engagement to enhance recovery for children undergoing surgery. [2018]

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

Preparing enhanced recovery after surgery for implementation in pediatric populations. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Enhanced recovery pathway in open and minimally invasive colorectal cancer surgery: a prospective study on feasibility, compliance, and outcomes in a high-volume resource limited tertiary cancer center. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. [2021]

7. Poland pubmed.ncbi.nlm.nih.gov

[The safety of pharmacotherapy in the light of monitoring adverse drug reaction]. [2013]

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

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Optimizing life success through residential immersive life skills programs for youth with disabilities: study protocol of a mixed-methods, prospective, comparative cohort study. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The My Strengths Training for Life™ program: Rationale, logic model, and description of a strengths-based intervention for young people experiencing homelessness. [2023]

13. Australia pubmed.ncbi.nlm.nih.gov

The equitable reach of a universal, multisector childhood obesity prevention program (Live Life Well @ School) in Australian primary schools. [2021]

14. England pubmed.ncbi.nlm.nih.gov

An evaluation of the "Youth en Route" program. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Evaluation of the childhood obesity prevention program Kids--'Go for your life'. [2021]