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Adaptation and Evaluation of Bright Horizons

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

Tracking Information
First Submitted Date  ICMJE February 15, 2023
First Posted Date  ICMJE February 24, 2023
Last Update Posted Date January 18, 2024
Estimated Study Start Date  ICMJE May 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2023)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2024)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adaptation and Evaluation of Bright Horizons
Official Title  ICMJE Adaptation and Evaluation of Bright Horizons: An Evidence Based Intervention for Prevention of Binge Drinking and Drug Use
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Abuse
  • Substance Use
Intervention  ICMJE
  • Behavioral: Bright Horizons
    Bright Horizons is a brief substance use intervention delivered by Research Program Assistants.
  • Behavioral: Case Management
    Placebo condition
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Bright Horizons
    • Behavioral: Case Management
  • 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.
    Intervention: Behavioral: Case Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2023)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Cwik, PhD 410-955-6931 mcwik1@jhu.edu
Contact: Novalene Goklish, PhD
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05743699
Other Study ID Numbers  ICMJE IRB00021437
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Johns Hopkins Bloomberg School of Public Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Native American Research Centers for Health
  • White Mountain Apache Tribe
Investigators  ICMJE
Principal Investigator: Mary Cwik, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP