Adaptation and Evaluation of Bright Horizons

• ClinicalTrials.gov Identifier: NCT05743699
• Recruitment Status: Not yet recruiting
• First Posted: February 24, 2023
• Last Update Posted: January 18, 2024
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Native American Research Centers for Health; White Mountain Apache Tribe
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

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
Alcohol Abuse; Substance Use	Behavioral: Bright Horizons; Behavioral: Case Management	Not Applicable

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 (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: May 2024
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 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 [ Time Frame: 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)

Secondary Outcome Measures :

1. Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
   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.
2. Impulsivity as assessed by the UPPS Impulsive Behavior Scale [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   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.
3. Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   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.
4. Peer Relationships as assessed by the Peer Norms questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   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.
5. Other substance use as assessed by the Youth Risk Behavior Survey (YBBS) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   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.
6. Enculturation as assessed by the Tribal identification scale [ Time Frame: Baseline, 4 weeks, 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Mary Cwik, PhD; 410-955-6931; mcwik1@jhu.edu

Contact: Novalene Goklish, PhD

Locations

United States, Arizona

Johns Hopkins Center for Indigenous Health - Whiteriver Site

Whiteriver, Arizona, United States, 85941

Contact: Novalene Goklish, PhD

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

More Information

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT05743699
• Other Study ID Numbers: IRB00021437
• First Posted: February 24, 2023
• Last Update Posted: January 18, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• 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:

Substance-Related Disorders; Alcoholism; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders