Optimizing a Drug Abuse Prevention Program for Dissemination (Bridges)

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.

Study Overview

• Status: Unknown
• Conditions: Mental Health; Substance Abuse; Educational Problems
• Intervention / Treatment: Behavioral: Bridges 4-week Program

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.

• Study Type: Interventional
• Enrollment (Actual): 664
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85287-1106
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Bridges Workshop; Participants will receive a one-time, 90-minute workshop.
Experimental: Bridges 4-week Program; 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.	Behavioral: Bridges 4-week Program; Participants receive 4, 2-hour sessions over a 6-week period.; Other Names: Bridges Program; BSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year.
Mental Health	Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.	1 Year
Academic Outcomes	School archival data (Grades, Disciplinary actions, and Absences)	1 Year

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Nancy A Gonzales, PhD, Foundation Professor of Psychology and Associate Dean of Faculty

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Risky Sexual Behavior; Substance Use and Abuse; Behavior Problems; Academic Achievement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 5R01DA035855-03 (U.S. NIH Grant/Contract); R01DA035855 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No