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Optimizing a Drug Abuse Prevention Program for Dissemination (Bridges)

Primary Purpose

Substance Abuse, Mental Health, Educational Problems

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bridges 4-week Program
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse focused on measuring Substance Use and Abuse, Risky Sexual Behavior, Behavior Problems, Academic Achievement

Eligibility Criteria

10 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adolescent enrolled in seventh grade in a participating school and their caregivers.

Exclusion Criteria:

  • 7th grade students with developmental delays and severe disruptive behavior disorder

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Bridges Workshop

Bridges 4-week Program

Arm Description

Participants will receive a one-time, 90-minute workshop.

Parents and adolescents will attend separate 1.25-hour groups simultaneously and then meet together for 45 minutes. Group meetings will be conducted at the school once per week for four weeks. Each week will cover a different topic. The parent program will focus on positive parenting and goal setting, parent-adolescent relationship strengthening, behavior management, and monitoring. The adolescent program will focus on personal goals and motivation, emotion regulation, cognitive control, and adaptive coping.

Outcomes

Primary Outcome Measures

Substance Use Problems and Risky Behaviors
Self reported drug and alcohol initiation and/or use (Monitoring the Future), sexual initiation and risky sexual behavior (adapted from the national 2001 Youth Risk Behavior Survey).
Mental Health
Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.
Academic Outcomes
School archival data (Grades, Disciplinary actions, and Absences)

Secondary Outcome Measures

Full Information

First Posted
April 13, 2017
Last Updated
July 2, 2018
Sponsor
Arizona State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03125291
Brief Title
Optimizing a Drug Abuse Prevention Program for Dissemination
Acronym
Bridges
Official Title
Optimizing a Drug Abuse Prevention Program for Dissemination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2015 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project is a hybrid efficacy/effectiveness trial of a streamlined version of the Bridges program, an evidence-based intervention (EBI) to prevent substance abuse and mental health disorders. Bridges is an integrated parent-youth intervention evaluated in a randomized controlled trial (RCT) with Mexican Americans (immigrant and U.S. born) that showed long-term effects on multiple outcomes: substance use initiation and escalation, externalizing and internalizing symptoms, deviant peer association, and grade point average (GPA) in early adolescence; alcohol abuse disorder, binge drinking, marijuana use, risky sexual behavior, diagnosed mental disorder, and school dropout in late adolescence. Building on evidence of core intervention components and strategies for redesigning EBIs for the real-world, investigators will partner with low-income, multiethnic schools to adapt the program to a brief, 4-session format (Bridges short program, BSP), and optimize engagement, delivery, training, and implementation monitoring systems to facilitate dissemination and sustainability. The proposed RCT will also examine whether a parent-youth EBI can impact multiple channels of youth self-regulation (e.g., biological, behavioral, emotional) during adolescence when neurobiological systems are changing rapidly, and whether preexisting individual differences in self-regulation moderate program effects.
Detailed Description
The goals of the RCT are to: 1) examine the effects of the BSP vs. a control group on targeted family and youth competencies at post-test, multiple systems of youth self-regulation at 6-month follow-up, and multiple youth outcomes at 1-year follow-up; 2) examine whether effects are mediated by program-induced improvements on targeted parent and youth competencies and by changes on multiple indicators of youth self-regulation; 3) examine program language (English vs. Spanish), baseline youth risk (including biological risk), and baseline family risk as moderators of BSP effects on youth outcomes and mediators; 4) examine whether variability in implementation accounts for variability in mediators and outcomes; and 5) conduct a cost analysis of the BSP vs. the original Bridges program, as well as estimate the cost-effectiveness of the BSP vs. the control group on delayed SU initiation and quantity and frequency of SU at 1-year follow-up. Following pretest interviews, 7th grade students and their parents will be randomized to receive the BSP 4 -week program or the control group within each school. Those parents and adolescents assigned to the BSP will attend separate 1.25-hour groups simultaneously and then meet together for 45 minutes. Group meetings will be conducted at the school once per week for four weeks. Each week will cover a different topic. The parent program will focus on positive parenting and goal setting, parent-adolescent relationship strengthening, behavior management, and monitoring. The adolescent program will focus on personal goals and motivation, emotion regulation, cognitive control, and adaptive coping. Free dinner and childcare will be provided during group meetings. The trial will include 3 additional assessment points beyond pretest: immediate posttest in 7th grade (W2), 6-month (W3) and one-year follow-up in 8th grade (W4). Assessment of multiple dimensions of self-regulation will address innovative questions for prevention. Teachers are asked to complete questionnaires; archival school data are also collected. The resulting intervention package and findings from the randomized trial will lay the foundation for dissemination of the BSP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Mental Health, Educational Problems
Keywords
Substance Use and Abuse, Risky Sexual Behavior, Behavior Problems, Academic Achievement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The interviewers are blind to the condition assigned to the families.
Allocation
Randomized
Enrollment
664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bridges Workshop
Arm Type
No Intervention
Arm Description
Participants will receive a one-time, 90-minute workshop.
Arm Title
Bridges 4-week Program
Arm Type
Experimental
Arm Description
Parents and adolescents will attend separate 1.25-hour groups simultaneously and then meet together for 45 minutes. Group meetings will be conducted at the school once per week for four weeks. Each week will cover a different topic. The parent program will focus on positive parenting and goal setting, parent-adolescent relationship strengthening, behavior management, and monitoring. The adolescent program will focus on personal goals and motivation, emotion regulation, cognitive control, and adaptive coping.
Intervention Type
Behavioral
Intervention Name(s)
Bridges 4-week Program
Other Intervention Name(s)
Bridges Program, BSP
Intervention Description
Participants receive 4, 2-hour sessions over a 6-week period.
Primary Outcome Measure Information:
Title
Substance Use Problems and Risky Behaviors
Description
Self reported drug and alcohol initiation and/or use (Monitoring the Future), sexual initiation and risky sexual behavior (adapted from the national 2001 Youth Risk Behavior Survey).
Time Frame
1 year.
Title
Mental Health
Description
Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.
Time Frame
1 Year
Title
Academic Outcomes
Description
School archival data (Grades, Disciplinary actions, and Absences)
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adolescent enrolled in seventh grade in a participating school and their caregivers. Exclusion Criteria: 7th grade students with developmental delays and severe disruptive behavior disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Gonzales, PhD
Organizational Affiliation
Foundation Professor of Psychology and Associate Dean of Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287-1106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing a Drug Abuse Prevention Program for Dissemination

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