Adaptation and Evaluation of Bright Horizons
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-24
SponsorJohns Hopkins Bloomberg School of Public Health
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bright Horizons
BehavioralBright Horizons is a brief substance use intervention delivered by Research Program Assistants.
Case Management
BehavioralPlacebo condition
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Case management + Bright HorizonsExperimental treatment 2 interventions
Group B: Case managementPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Alcohol Use as assessed by Timeline Followback
Alcohol use over the past 30 days (Timeline Followback to assess number of drinking days and number of drinks per day)
Time frame
Baseline, 4 weeks and 8 weeks post-interventionSecondary outcomes
1
Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale
Difficulties in emotion regulation scale is a 36-item instrument that asks individuals to rate their difficulties in regulating emotions including non-acceptance of emotional responses, awareness of emotions and access to regulation strategies. Scores can range from 36 to 180, with higher scores indicating more difficulties in regulating emotions.
Time frame
Baseline, 4 weeks, and 8 weeks2
Impulsivity as assessed by the UPPS Impulsive Behavior Scale
UPPS Impulsive Behavior Scale is a 45-item inventory designed to measure four personality pathways to impulsive behavior: Urgency to Act, Lack of Perseverance, Lack of Premeditation, and Sensation Seeking, each rated on a 4-point scale. Scores can range from 45 to 180, with higher scores indicating more impulsivity.
Time frame
Baseline, 4 weeks, 8 weeks3
Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale
Problem-oriented screening instrument (POSIT) Family Functioning Items is a 10 item scale that measures family functioning around parenting, communication and child monitoring. Responses No=0 and Yes=1. A score of 8 shows healthier family functioning, and a score of 2 shows worse family functioning.
Time frame
Baseline, 4 weeks, 8 weeks4
Peer Relationships as assessed by the Peer Norms questionnaire
Peer Norms measure is a 20-item measure asking about peer behaviors and the participant's perception of peer behaviors. Topics include sexual activity, drinking and other substance use. Peer groups discussed include best friends, people in their grade, and people their age. Scores can range from 11 to 60, with higher scores indicating more peer pressure and less healthy peer relationships.
Time frame
Baseline, 4 weeks, 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Native American Research Center for Health
Collaborator
White Mountain Apache Tribe
Collaborator
Source ClinicalTrials.gov