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Bright Horizons for Substance Abuse
N/A
Waitlist Available
Led By Mary Cwik, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Summary
This trial will test if Bright Horizons can reduce binge substance use among adolescents.
Who is the study for?
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.
What is being tested?
'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.
What are the potential side effects?
Since 'Bright Horizons' involves educational and behavioral strategies rather than medication, there are no direct physical side effects like you'd expect with drugs. However, discussing sensitive topics might be emotionally challenging for some participants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Alcohol Use as assessed by Timeline Followback
Secondary study objectives
Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale
Enculturation as assessed by the Tribal identification scale
Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Case management + Bright HorizonsExperimental Treatment2 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 managementPlacebo Group2 Interventions
Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Case Management
2012
Completed Phase 2
~3370
Find a Location
Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
425 Previous Clinical Trials
2,127,147 Total Patients Enrolled
2 Trials studying Alcoholism
786 Patients Enrolled for Alcoholism
Native American Research Centers for HealthUNKNOWN
4 Previous Clinical Trials
787 Total Patients Enrolled
White Mountain Apache TribeUNKNOWN
1 Previous Clinical Trials
183 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe health, mental, or substance use issues requiring hospital stay.I do not speak English.I have severe vision loss.I am between 12 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Case management + Bright Horizons
- Group 2: Case management
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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