NCT03125291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
664

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

April 13, 2017

Last Update Submit

July 2, 2018

Conditions

Substance AbuseMental HealthEducational Problems

Keywords

Substance Use and AbuseRisky Sexual BehaviorBehavior ProblemsAcademic Achievement

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Bridges Workshop

NO INTERVENTION

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

Bridges 4-week Program

EXPERIMENTAL

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

Interventions

Bridges 4-week ProgramBEHAVIORAL

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

Also known as: Bridges Program, BSP
Bridges 4-week Program

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287-1106, United States

Location

Related Publications (1)

  • 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.

    PMID: 37633858DERIVED

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-BeingMental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersPersonal SatisfactionBehavior

Study Officials

  • Nancy A Gonzales, PhD

    Foundation Professor of Psychology and Associate Dean of Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The interviewers are blind to the condition assigned to the families.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Foundation Professor of Psychology

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 24, 2017

Study Start

July 28, 2015

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

July 5, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)