Adaptation and Evaluation of Bright Horizons

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05743699
Collaborator
Native American Research Centers for Health (Other), White Mountain Apache Tribe (Other)
100
2
22

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bright Horizons
  • Behavioral: Case Management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Alcohol Use as assessed by Timeline Followback [Baseline, 4 weeks and 8 weeks post-intervention]

    Alcohol use over the past 30 days (Timeline Followback to assess number of drinking days and number of drinks per day)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Native American Research Centers for Health
  • White Mountain Apache Tribe

Investigators

  • Principal Investigator: Mary Cwik, PhD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT05743699
Other Study ID Numbers:
  • IRB00021437
First Posted:
Feb 24, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023