Substance AbuseBridgesNCT03125291
Optimizing a Drug Abuse Prevention Program for Dissemination
A study testing Bridges 4-week Program in people with Substance Abuse and Mental Health, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Mental Health, Educational Problems
- What is being tested?
- Bridges 4-week Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2015to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent enrolled in seventh grade in a participating school and their caregivers.
Who cannot join
- 7th grade students with developmental delays and severe disruptive behavior disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Bridges 4-week Program
- Keywords
- Substance Use and Abuse, Risky Sexual Behavior, Behavior Problems, Academic Achievement
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridges 4-week ProgramBehavioural
Also called Bridges Program, BSP
Participants receive 4, 2-hour sessions over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bridges 4-week Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year.
Mental Health
Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.
Measured: 1 Year
Academic Outcomes
School archival data (Grades, Disciplinary actions, and Absences)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start28 Jul 2015
- Primary completionApr 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nancy Gonzales, Arizona State University
- Investigators
- Nancy A Gonzales, PhD, Principal investigator, Foundation Professor of Psychology and Associate Dean of Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125291
- Sponsor's protocol ID
- 5R01DA035855-03
- Other IDs
- R01DA035855
- Acronym
- Bridges
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37633858
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Drug Abuse Prevention Program for Dissemination
- ClinicalTrials.gov ID
- NCT03125291
- Acronym / sponsor ID
- Bridges / 5R01DA035855-03
- Conditions
- Substance Abuse, Mental Health, Educational Problems
- Keywords
- Substance Use and Abuse, Risky Sexual Behavior, Behavior Problems, Academic Achievement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridges Workshop | No intervention | –Participants will receive a one-time, 90-minute workshop. |
| Bridges 4-week Program | Experimental | Behavioral: Bridges 4-week ProgramParents 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescent enrolled in seventh grade in a participating school and their caregivers.
Key exclusion criteria (1 listed)
- 7th grade students with developmental delays and severe disruptive behavior disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridges 4-week ProgramAlso: Bridges Program, BSPParticipants receive 4, 2-hour sessions over a 6-week period. | Behavioural | Bridges 4-week Program |
Primary outcome
Substance Use Problems and Risky Behaviors
Time frame: 1 year.
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
Time frame: 1 Year
Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.
Academic Outcomes
Time frame: 1 Year
School archival data (Grades, Disciplinary actions, and Absences)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Derived from this study: PubMed 37633858Hidalgo 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.
- Individual participant dataSharing planned: No
Related trials for Substance Abuse
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Not yet recruitingPhase 1/2
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
Treatment Resistant Depression, Substance Use Disorders
RecruitingObservational study
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Voiding Dysfunction, Substance Abuse
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Gonzales, PhD principal investigator
Foundation Professor of Psychology and Associate Dean of Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridges 4-week Program in people with Substance Abuse and Mental Health, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance Use Problems and Risky Behaviors (time frame: 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03125291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.