NCT05743699

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jul 2025Jan 2027

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 17, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

February 15, 2023

Last Update Submit

June 5, 2026

Conditions

Alcohol AbuseSubstance Use

Outcome Measures

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)

    Baseline, 4 weeks and 8 weeks post-intervention

Secondary Outcomes (6)

  • Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale

    Baseline, 4 weeks, and 8 weeks

  • Impulsivity as assessed by the UPPS Impulsive Behavior Scale

    Baseline, 4 weeks, 8 weeks

  • Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale

    Baseline, 4 weeks, 8 weeks

  • Peer Relationships as assessed by the Peer Norms questionnaire

    Baseline, 4 weeks, 8 weeks

  • Other substance use as assessed by the Youth Risk Behavior Survey (YBBS)

    Baseline, 4 weeks, 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Case management + Bright Horizons

EXPERIMENTAL

Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.

Behavioral: Bright HorizonsBehavioral: Case Management

Case management

PLACEBO COMPARATOR

Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.

Behavioral: Case Management

Interventions

Case ManagementBEHAVIORAL

Placebo condition

Case managementCase management + Bright Horizons
Bright HorizonsBEHAVIORAL

Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.

Case management + Bright Horizons

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Center for Indigenous Health - Whiteriver Site

Whiteriver, Arizona, 85941, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mary Cwik, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Cwik, PhD

CONTACT

410-955-6931mcwik1@jhu.edu

Novalene Goklish, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

July 17, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)