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Recruiting NCT05743699

Adaptation and Evaluation of Bright Horizons

No phase Interventional Alcohol Abuse Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bright Horizons, Case Management.
Who it may be relevant to
Registry conditions: Alcohol Abuse, Substance Use. Basic parameters: 10 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use

Overview

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.

Detailed description

The goal of this study is to understand how Bright Horizons impacts adolescents who have a recent binge substance use event. Participants will receive a lesson on binge substance use and answer questions at three different time points: when participants enroll in the study; 4 weeks later; and 8 weeks after that visit. Evaluation questions will ask about participants' substance use, family and peer relationships, and other emotions and behaviors.

Control participants will receive the Bright Horizons intervention after enrollment of all intervention participants is complete.

Interventions

  • Behavioral Bright Horizons
    Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.
  • Behavioral Case Management
    Placebo condition

Primary outcome measures

  • Change in Alcohol Use as assessed by Timeline Followback [Time frame: Baseline, 4 weeks and 8 weeks post-intervention]
Secondary outcome measures (6)
  • Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale [Time frame: Baseline, 4 weeks, and 8 weeks]
  • Impulsivity as assessed by the UPPS Impulsive Behavior Scale [Time frame: Baseline, 4 weeks, 8 weeks]
  • Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale [Time frame: Baseline, 4 weeks, 8 weeks]
  • Peer Relationships as assessed by the Peer Norms questionnaire [Time frame: Baseline, 4 weeks, 8 weeks]
  • Other substance use as assessed by the Youth Risk Behavior Survey (YBBS) [Time frame: Baseline, 4 weeks, 8 weeks]
  • Enculturation as assessed by the Tribal identification scale [Time frame: Baseline, 4 weeks, 8 weeks]

Eligibility criteria

Inclusion criteria

  • Aged 10-24
  • 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
  • Have parental or legal guardian consent/provide youth assent

Exclusion criteria

  • Unstable and severe medical, psychiatric or drug use problems that necessitates inpatient treatment
  • 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
  • Doesn't speak English
  • Severally visually impaired

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins Center for Indigenous Health - Whiteriver Site — Whiteriver

Identifiers

NCT: NCT05743699 · IRB00021437

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗