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

Trial Summary

What is the purpose of this trial?

This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents. Bright Horizons is a culturally adapted intervention developed and tested through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. The intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.

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 data supports the effectiveness of the Bright Horizons treatment for substance abuse?

Research shows that substance abuse treatments can lead to significant improvements in areas like alcohol and drug use, employment, and psychological function. Long-term treatments tend to result in better outcomes than short-term ones, suggesting that comprehensive approaches like Bright Horizons may be beneficial. ^{1 2 3 4 5}

Is the Bright Horizons treatment generally safe for humans?

The available research does not provide specific safety data for the Bright Horizons treatment or its related names like Case Management or Geriatric Case Management. The studies focus on general adverse drug events and safety reporting in substance abuse trials, but do not offer direct safety information for this treatment. ^{6 7 8 9 10}

How is the Bright Horizons treatment different from other substance abuse treatments?

The Bright Horizons treatment may be unique in its approach or components, but the provided research does not offer specific details about its differences from existing treatments for substance abuse. Existing research highlights the limited efficacy of brief interventions for drug use, suggesting that Bright Horizons might offer a novel approach if it addresses these limitations. ^{11 12 13 14 15}

Research Team

Mary Cwik, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

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

Timeline

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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