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Adaptation and Evaluation of Bright Horizons

Primary Purpose

Alcohol Abuse, Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright Horizons
Case Management
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Center for Indigenous Health - Whiteriver Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Case management + Bright Horizons

Case management

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
September 8, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Native American Research Centers for Health, White Mountain Apache Tribe
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1. Study Identification

Unique Protocol Identification Number
NCT05743699
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Native American Research Centers for Health, White Mountain Apache Tribe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case management + Bright Horizons
Arm Type
Experimental
Arm Description
Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant.
Arm Title
Case management
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system.
Intervention Type
Behavioral
Intervention Name(s)
Bright Horizons
Intervention Description
Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.
Intervention Type
Behavioral
Intervention Name(s)
Case Management
Intervention Description
Placebo condition
Primary Outcome Measure Information:
Title
Change in Alcohol Use as assessed by Timeline Followback
Description
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-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Cwik, PhD
Phone
410-955-6931
Email
mcwik1@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Novalene Goklish, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Cwik, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Center for Indigenous Health - Whiteriver Site
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Novalene Goklish, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation and Evaluation of Bright Horizons

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