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NCT Number: NCT05743699

Adaptation and Evaluation of Bright Horizons

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.

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Key information

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for Indigenous Health - Whiteriver Site

Whiteriver, Arizona, 85941, United States

Location status: Recruiting

Location contact

Novalene Goklish, PhD

CONTACT

About this study

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 8 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 10-24
  • 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

Treatment and study plan

Bright Horizons

Behavioral

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

Case Management

Behavioral

Placebo condition

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Cwik, PhD

CONTACT

[email protected]

410-955-6931

Novalene Goklish, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Native American Research Center for Health
  • White Mountain Apache Tribe

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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