Bright Horizons for Substance Abuse

Overseen By Novalene Goklish, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Severe medical, psychiatric, drug problems, others

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a program called 'Bright Horizons' can reduce binge substance use among Native American teens. The program teaches skills such as managing emotions, coping with stress, and solving problems, while also setting goals to reduce alcohol and drug use. Participants will receive either this program with case management or standard case management for comparison. Teens who may qualify have recently experienced a binge drinking event and live on or near the Fort Apache Indian Reservation. As an unphased trial, this study provides a unique opportunity to contribute to research that could benefit the community.

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.

What prior data suggests that the Bright Horizons program is safe for adolescents?

Research has shown that the Bright Horizons program focuses on teaching skills such as managing emotions and solving problems. It aims to reduce alcohol and substance use among teenagers. While specific safety data is unavailable, the program is non-invasive and primarily educational, suggesting minimal risk.

Developed in collaboration with the White Mountain Apache Tribe and Johns Hopkins University, the program emphasizes cultural sensitivity and relies on proven methods. This partnership reflects a thoughtful and respectful approach to its development.

Since Bright Horizons does not involve medication or physical procedures, participants are likely to tolerate it well. Available sources report no negative effects related to the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for substance abuse rely on medication-assisted therapy or counseling. But Bright Horizons offers a fresh approach by combining case management with a specialized intervention session. This session is notably extensive, lasting 2-4 hours, and is facilitated by a Research Program Assistant, which provides personalized support. Unlike traditional methods, which may take longer to see results, this focused intervention aims to deliver impactful assistance in a single session. Researchers are excited about its potential to provide quicker, more personalized care for individuals struggling with substance abuse.

What evidence suggests that this trial's treatments could be effective for reducing binge substance use among adolescents?

Research shows that Bright Horizons, one of the treatments in this trial, might help reduce binge substance use among teenagers. Bright Horizons is a short program that teaches young people how to handle their emotions, solve problems, and set personal goals. Studies have found that it connects participants with treatment resources, which can help them cut down on alcohol and drug use. The program was created with the White Mountain Apache Tribe and Johns Hopkins University to be culturally relevant and effective for different communities. While more information is needed, these early results suggest that building skills and providing support can help reduce substance use. Participants in this trial may receive Bright Horizons combined with case management, or they may receive standard case management alone. ^{6 7 8 9 10}

Who Is on the Research Team?

Mary Cwik, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Native American adolescents aged 12-17 who have had a binge alcohol use event recently and live near the Fort Apache Indian Reservation. They need consent from a parent or guardian to join. Those with severe medical, psychiatric issues, immediate suicidal thoughts, recent trauma requiring intense intervention, non-English speakers, or severe visual impairment cannot participate.

Inclusion Criteria

Confirmed binge alcohol use event reported to the surveillance system within 90 days

Self identify as Native American

Reside on or near the Fort Apache Indian Reservation

Exclusion Criteria

Acute suicidal or homicidal ideation requiring immediate intervention

Recent and severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement

I do not have severe health, mental, or substance use issues requiring hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Bright Horizons intervention, which includes a 2-4 hour session focusing on emotion regulation, coping skills, and problem solving.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in substance use, family and peer relationships, and other behaviors at 4 and 8 weeks post-intervention.

8 weeks

2 visits (in-person)

Control Group Intervention

Control participants receive the Bright Horizons intervention after the main intervention group completes their sessions.

What Are the Treatments Tested in This Trial?

Interventions

• Bright Horizons
• Case Management

Trial Overview

'Bright Horizons' is being tested in this study. It's an intervention program designed to help young people manage their emotions better and make smarter choices about substance use by teaching them coping skills and problem-solving techniques.

How Is the Trial Designed?

Group I: Case management + Bright Horizons Experimental Treatment 2 Interventions

Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.

Group II: Case management Placebo Group 2 Interventions

Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Native American Research Center for Health

Collaborator

Trials

6

Recruited

1,300+

Native American Research Centers for Health

Collaborator

Trials

5

Recruited

890+

White Mountain Apache Tribe

Collaborator

Trials

2

Recruited

280+

Published Research Related to This Trial

In a study analyzing 1,567,659 hospital discharges in Spain from 2005-2007, 96,607 adverse drug events (ADEs) were identified, representing 5.55% of all discharges, with a significant portion (82.86%) deemed not preventable.

The study found that adverse drug reactions (ADRs) were more common in women and led to longer hospital stays, highlighting the importance of monitoring and reporting ADEs for improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. Zapatero Gaviria, A., Barba, R., Ruiz Giardin, JM., et al.[2013]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

Identifying and documenting adverse drug events (ADEs) is crucial for assessing the therapeutic value of new drug treatments during early development phases.

The methods for eliciting ADEs differ based on the sources of information (such as patients or physicians) and the specific areas of study, which can include general health scales or specialized motor performance assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of adverse drug events during the clinical investigation of a new drug. Koeppen, D., Mohr, R., Streichenwein, S.[2013]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

Citations

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Our study aims are to: 1) to use a qualitative positive deviance approach to identify strengths and skills of at-risk youth (12-17 years old: N=30) who do not ...

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This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents. Bright Horizons is a culturally ...

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This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents. Bright Horizons is a culturally ...

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Brief Intervention in Primary Care for Problem Drug Use and Abuse

The results of the study will have implications for whether it is advisable to expand its application beyond hazardous alcohol abuse to include abuse of drugs.

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Substance-Related Disorders (DBCOND0027888)

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