Optimizing a Drug Abuse Prevention Program for Dissemination

NCT ID: NCT03125291

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 664 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-28
• Study Completion Date: 2019-09-30

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.

Conditions

Substance Abuse; Mental Health; Educational Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Bridges Workshop

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Bridges 4-week Program

Intervention Type: BEHAVIORAL

Participants receive 4, 2-hour sessions over a 6-week period.

Interventions

Bridges 4-week Program

Participants receive 4, 2-hour sessions over a 6-week period.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bridges Program; BSP

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Gonzales

Foundation Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy A Gonzales, PhD

Role: PRINCIPAL_INVESTIGATOR

Foundation Professor of Psychology and Associate Dean of Faculty

Locations

Arizona State University

Tempe, Arizona, United States

Countries

United States

References

Hidalgo SG, Kim JJ, Tein JY, Gonzales NA. Are Discrepancies Between Father and Adolescent Perceptions of Harsh Parenting and Conflict Associated with Adolescent Mental Health Symptoms? J Youth Adolesc. 2023 Dec;52(12):2578-2591. doi: 10.1007/s10964-023-01842-2. Epub 2023 Aug 26.

Reference Type: DERIVED

PMID: 37633858 (View on PubMed)

Other Identifiers

R01DA035855

Identifier Type: NIH

Identifier Source: secondary_id

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5R01DA035855-03

Identifier Type: NIH

Identifier Source: org_study_id

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