Adaptation and Evaluation of Bright Horizons

NCT ID: NCT05743699

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Alcohol Abuse Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bright Horizons

Intervention Type BEHAVIORAL

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

Case Management

Intervention Type BEHAVIORAL

Placebo condition

Case management

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

Group Type PLACEBO_COMPARATOR

Case Management

Intervention Type BEHAVIORAL

Placebo condition

Interventions

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Bright Horizons

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

Intervention Type BEHAVIORAL

Case Management

Placebo condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Native American Research Center for Health

OTHER

Sponsor Role collaborator

White Mountain Apache Tribe

UNKNOWN

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Cwik, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Johns Hopkins Center for Indigenous Health - Whiteriver Site

Whiteriver, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary Cwik, PhD

Role: CONTACT

410-955-6931

Novalene Goklish, PhD

Role: CONTACT

Facility Contacts

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Novalene Goklish, PhD

Role: primary

Other Identifiers

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IRB00021437

Identifier Type: -

Identifier Source: org_study_id

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