Adaptation and Evaluation of Bright Horizons

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05743699
• Other study ID #: IRB00021437
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Mary Cwik, PhD
• Phone: 410-955-6931
• Email: mcwik1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Bright Horizons
Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.
• Case Management
Placebo condition

Locations

Country	Name	City	State
United States	Johns Hopkins Center for Indigenous Health - Whiteriver Site	Whiteriver	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Native American Research Centers for Health, White Mountain Apache Tribe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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