Clinical trial NCT05743699: Adaptation and Evaluation of Bright Horizons
Official title: Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Substance Use
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Native American Research Center for Health
name: White Mountain Apache Tribe
First posted: 2023-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 4 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.

Eligibility criteria: Inclusion Criteria:

* Aged 12-17
* 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

Primary outcomes:
measure: Change in Alcohol Use as assessed by Timeline Followback
timeFrame: Baseline, 4 weeks and 8 weeks post-intervention
Secondary outcomes:
measure: Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Impulsivity as assessed by the UPPS Impulsive Behavior Scale
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Peer Relationships as assessed by the Peer Norms questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Other substance use as assessed by the Youth Risk Behavior Survey (YBBS)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Enculturation as assessed by the Tribal identification scale
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for Indigenous Health - Whiteriver Site
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Mary Cwik, PhD
role: PRINCIPAL_INVESTIGATOR
References: