Adaptation and Evaluation of Bright Horizons (BH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use; Alcohol Abuse
• Intervention / Treatment: Behavioral: Bright Horizons; Behavioral: Case Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Cwik, PhD; Phone Number: 410-955-6931; Email: mcwik1@jhu.edu
• Study Contact Backup: Name: Novalene Goklish, PhD

Study Locations

• United States
  • Arizona
    • Whiteriver, Arizona, United States, 85941
      • Recruiting
      • Johns Hopkins Center for Indigenous Health - Whiteriver Site
      • Contact: Novalene Goklish, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case management + Bright Horizons; Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.	Behavioral: Bright Horizons; Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.; Behavioral: Case Management; Placebo condition
Placebo Comparator: Case management; Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.	Behavioral: Case Management; Placebo condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, 4 weeks and 8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 weeks, and 8 weeks
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.	Baseline, 4 weeks, 8 weeks
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.	Baseline, 4 weeks, 8 weeks
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.	Baseline, 4 weeks, 8 weeks
Other substance use as assessed by the Youth Risk Behavior Survey (YBBS)	Youth Risk Behavior Survey (YRBS) was developed so youth can describe their behaviors that may affect their health. For this study, 19 items have been selected that ask about alcohol, marijuana, and other substance use. Scores can range from 0 to 99, with higher scores indicating more/worse substance use.	Baseline, 4 weeks, 8 weeks
Enculturation as assessed by the Tribal identification scale	Tribal identification scale comprises 7 questions that ask about identity and connection to ones tribal community. Scores can range from 7 to 35, with higher scores indicating less connection with tribal community.	Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: White Mountain Apache Tribe; Native American Research Center for Health
• Investigators: Principal Investigator: Mary Cwik, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Substance-Related Disorders; Health Services Administration; Patient Care Management; Patient Care Planning; Comprehensive Health Care; Case Management
• Other Study ID Numbers: IRB00021437; S06GM142120 (U.S. NIH Grant/Contract); S06GM142120-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No