Alcohol AbuseNCT05743699
Adaptation and Evaluation of Bright Horizons
A study testing Bright Horizons and Case Management in people with Alcohol Abuse and Substance Use, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Alcohol Abuse, Substance Use
- What is being tested?
- Bright Horizons and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novalene Goklish, PhD contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Center for Indigenous Health - Whiteriver Site
Whiteriver, Arizona, 85941
Novalene Goklish, PhD
About this study
Official title: Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use
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.
Read the 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 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.
- Conditions
- Alcohol Abuse, Substance Use
- Being tested
- Bright Horizons, Case Management
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright HorizonsBehavioural
Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.
Case ManagementBehavioural
Placebo condition
| Study group | Role | What they receive |
|---|---|---|
| Case management + Bright Horizons | Experimental | Participants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant. Receives: Behavioral: Bright Horizons; Behavioral: Case Management |
| Case management | Placebo comparator | Participants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system. Receives: Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 4 weeks and 8 weeks post-intervention
Secondary outcomes (6)
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.
Measured: Baseline, 4 weeks, and 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start17 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Native American Research Center for Health, White Mountain Apache Tribe
- Responsible party
- Sponsor
- Investigators
- Mary Cwik, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743699
- Sponsor's protocol ID
- IRB00021437
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use
- ClinicalTrials.gov ID
- NCT05743699
- Acronym / sponsor ID
- IRB00021437
- Conditions
- Alcohol Abuse, Substance Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Native American Research Center for Health, White Mountain Apache Tribe
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management + Bright Horizons | Experimental | Behavioral: Bright Horizons, Behavioral: Case ManagementParticipants enrolled into the Bright Horizons intervention group will receive one 2-4 hour long session with an Research Program Assistant. |
| Case management | Placebo comparator | Behavioral: Case ManagementParticipants in the control group will receive standard case management via the White Mountain Apache suicide and self-harm surveillance system. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright HorizonsBright Horizons is a brief substance use intervention delivered by Research Program Assistants. | Behavioural | Case management + Bright Horizons |
| Case ManagementPlacebo condition | Behavioural | Case management, Case management + Bright Horizons |
Primary outcome
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)
6 secondary outcomes
Coping with Stressful Life Events as assessed by the Difficulties in emotion regulation scale
Time frame: Baseline, 4 weeks, and 8 weeks
Impulsivity as assessed by the UPPS Impulsive Behavior Scale
Time frame: Baseline, 4 weeks, 8 weeks
Family Functioning as assessed by the Problem-oriented screening instrument (POSIT) Family Functioning scale
Time frame: Baseline, 4 weeks, 8 weeks
Peer Relationships as assessed by the Peer Norms questionnaire
Time frame: Baseline, 4 weeks, 8 weeks
Other substance use as assessed by the Youth Risk Behavior Survey (YBBS)
Time frame: Baseline, 4 weeks, 8 weeks
Enculturation as assessed by the Tribal identification scale
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novalene Goklish, PhD contact
Mary Cwik, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Horizons and Case Management in people with Alcohol Abuse and Substance Use, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Cwik, PhD (410-955-6931, mcwik1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use as assessed by Timeline Followback (time frame: Baseline, 4 weeks and 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.