Risk-TakingNCT03370393
Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects
A study testing Pathways for African-Americans' Success (PAAS) in people with Risk-Taking and Adolescent Behavior, run by University of California, Irvine at 1 site in United States.
Trial summary
Adolescence is a time of biological and behavioral changes that can lead to risky and dangerous behaviors, and African-American youth are highly vulnerable to the consequences of risky behavior, including HIV/AIDS and violence, leading to premature death. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk-Taking, Adolescent Behavior
- What is being tested?
- Pathways for African-Americans' Success (PAAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is of African-American racial status (self-reported)
- Subject can speak and read English
- Subject and parent/legal guardian agree to participate in the 6-week PAAS program
- Subject and parent/legal guardian agree to complete all assessments
- Subject must meet MRI safety eligibility
Who cannot join
- Subject has a major medical problem (e.g. neurological disorders)
- Subject is on medication(s) that affects the central nervous system
- Subject has behavioral/emotional problems at a clinical level (parent and/or youth report)
- Subject is pregnant or suspected of being pregnant (based on pregnancy test)
- Subject is color-blind
- Subject has claustrophobia
Show all 9Show fewer
- Subject has metallic implants
- Subject drinks alcohol in the week prior to entry into the study (based on urine drug screen)
- Subject uses drugs in the week prior to entry into the study (based on urine drug screen)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92617
About this study
Adolescence is a time of biological and behavioral changes that can lead to risky and dangerous behaviors, and African-American youth are highly vulnerable to the consequences of risky behavior, including HIV/AIDS and violence, leading to premature death. The investigators previously showed that an intervention program reduces HIV-risk vulnerability behaviors in many African-American youth. The investigators aim to measure how the program affects different regions of the brain in order to better prevent or reduce such risky behaviors among African-American youth.
Read the detailed description
Adolescence is a time of dramatic biological, behavioral and social changes. It is one of the healthiest periods of the life-span, yet morbidity and mortality rates increase 200%, often attributed to natural tendencies to explore and take risks that increase vulnerability to risky and dangerous behaviors. Rapid advances in developmental neuroscience are revealing new insights into how biology and social context interact to increase adolescents' risk-taking behavior which is attributed to a temporal disassociation between maturational changes in two distinct neural systems: "socio-emotional" (reward) and "cognitive-control" (self-regulation). The socio-emotional system is stimulated by a rapid increase in dopaminergic activity at puberty, which influences reward-seeking behavior. This increase in reward-seeking precedes the maturation of the cognitive-control system and its connections to the reward system. This proposal aims to apply these new insights on neurobiology of adolescents' responses to alcohol/drug use and sex-related risk opportunities by examining brain changes in response to a theoretically-based and empirically-tested prevention program that targets risky behavior in African-American youth during pubertal transition. This racial group is disproportionately affected by the high morbidity and mortality associated with HIV-related risky behaviors and exemplifies a significant health disparity in our society. The intervention was designed on the basis of developmental issues and socio-cultural contextual processes germane to African-American families, and has been shown in randomized controlled trials to delay/deter HIV-related risky behaviors in this vulnerable population. This proposal extends the efficacy studies of the intervention by using functional magnetic resonance imaging to quantify the biological changes in response to the intervention. Identifying neural substrates of the intervention can facilitate refinement of the program by focusing on the components that are most effective in changing behavioral and neural circuitry and also aid in the development of new interventions for subgroups of youth that don't have a positive outcome. Using a randomized controlled design, the investigators will assess the neural substrates of risk-taking and risk-avoidant behavior before and after the 6-week computer-interactive, family-based intervention in 11-13 year-old African-American youth. Psychological processes shown to mediate the intervention effects on behaviors that dissuade alcohol and drug use and sexual onset (i.e. reward-drive and cognitive-emotional self-regulation) will be assessed at baseline and 3 months post-intervention. Based on prior studies that reported observable brain changes in response to psychosocial interventions, the investigators' hypothesis is that a positive response to the intervention will be associated with greater functional connectivity changes between the socio-emotional (reward-drive) and cognitive-control (self-regulation) components of the neural circuitry compared to the control condition, both at rest and during task-performance. They also postulate that these neural changes will mediate the intervention's positive effects on psychological processes involved in youth's decision to avoid HIV-risk vulnerability behaviors in the service of long-term personal goals and positive health outcomes.
- Conditions
- Risk-Taking, Adolescent Behavior
- Being tested
- Pathways for African-Americans' Success (PAAS)
- Keywords
- Reward-drive, Cognitive-control
- Medical subject headings
- Risk-Taking, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways for African-Americans' Success (PAAS)Behavioural
PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
| Study group | Role | What they receive |
|---|---|---|
| Pathways for African-Americans' Success | Experimental | Subjects will complete a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks. Receives: Behavioral: Pathways for African-Americans' Success (PAAS) |
| Wait-list | No intervention | Subjects will be on waiting list for active intervention and will receive the PAAS intervention at the end of the study (same as active intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Emotional Regulation
Emotional regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in emotion regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
Measured: 18 weeks (from pre-intervention to 3-months after post-intervention)
Secondary outcomes (1)
Changes in Cognitive Regulation
Cognitive regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in cognitive regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
Measured: 18 weeks (from pre-intervention to 3-months after post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start11 Dec 2017
- Primary completion31 Mar 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Risk-TakingStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Model description
- The families will be randomized to Pathways for African Americans' Success (PAAS) intervention program or a wait-list condition (1:1 ratio) for 6 weeks. The wait-list group has the option to participate in the PAAS program at the end of the study.
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Uma Rao, University of California, Irvine
- Investigators
- Uma Rao, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370393
- Sponsor's protocol ID
- 20173439
- Other IDs
- R01DA040966
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2017
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects
- ClinicalTrials.gov ID
- NCT03370393
- Acronym / sponsor ID
- 20173439
- Conditions
- Risk-Taking, Adolescent Behavior
- Keywords
- Reward-drive, Cognitive-control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescence is a time of biological and behavioral changes that can lead to risky and dangerous behaviors, and African-American youth are highly vulnerable to the consequences of risky behavior, including HIV/AIDS and violence, leading to premature death. The investigators previously showed that an intervention program reduces HIV-risk vulnerability behaviors in many African-American youth. The investigators aim to measure how the program affects different regions of the brain in order to better prevent or reduce such risky behaviors among African-American youth.
Detailed description
Adolescence is a time of dramatic biological, behavioral and social changes. It is one of the healthiest periods of the life-span, yet morbidity and mortality rates increase 200%, often attributed to natural tendencies to explore and take risks that increase vulnerability to risky and dangerous behaviors. Rapid advances in developmental neuroscience are revealing new insights into how biology and social context interact to increase adolescents' risk-taking behavior which is attributed to a temporal disassociation between maturational changes in two distinct neural systems: "socio-emotional" (reward) and "cognitive-control" (self-regulation). The socio-emotional system is stimulated by a rapid increase in dopaminergic activity at puberty, which influences reward-seeking behavior. This increase in reward-seeking precedes the maturation of the cognitive-control system and its connections to the reward system. This proposal aims to apply these new insights on neurobiology of adolescents' responses to alcohol/drug use and sex-related risk opportunities by examining brain changes in response to a theoretically-based and empirically-tested prevention program that targets risky behavior in African-American youth during pubertal transition. This racial group is disproportionately affected by the high morbidity and mortality associated with HIV-related risky behaviors and exemplifies a significant health disparity in our society. The intervention was designed on the basis of developmental issues and socio-cultural contextual processes germane to African-American families, and has been shown in randomized controlled trials to delay/deter HIV-related risky behaviors in this vulnerable population. This proposal extends the efficacy studies of the intervention by using functional magnetic resonance imaging to quantify the biological changes in response to the intervention. Identifying neural substrates of the intervention can facilitate refinement of the program by focusing on the components that are most effective in changing behavioral and neural circuitry and also aid in the development of new interventions for subgroups of youth that don't have a positive outcome. Using a randomized controlled design, the investigators will assess the neural substrates of risk-taking and risk-avoidant behavior before and after the 6-week computer-interactive, family-based intervention in 11-13 year-old African-American youth. Psychological processes shown to mediate the intervention effects on behaviors that dissuade alcohol and drug use and sexual onset (i.e. reward-drive and cognitive-emotional self-regulation) will be assessed at baseline and 3 months post-intervention. Based on prior studies that reported observable brain changes in response to psychosocial interventions, the investigators' hypothesis is that a positive response to the intervention will be associated with greater functional connectivity changes between the socio-emotional (reward-drive) and cognitive-control (self-regulation) components of the neural circuitry compared to the control condition, both at rest and during task-performance. They also postulate that these neural changes will mediate the intervention's positive effects on psychological processes involved in youth's decision to avoid HIV-risk vulnerability behaviors in the service of long-term personal goals and positive health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The families will be randomized to Pathways for African Americans' Success (PAAS) intervention program or a wait-list condition (1:1 ratio) for 6 weeks. The wait-list group has the option to participate in the PAAS program at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| Pathways for African-Americans' Success | Experimental | Behavioral: Pathways for African-Americans' Success (PAAS)Subjects will complete a 6-week Pathways for African-Americans' Success (PAAS) intervention. This is a weekly, 1.5 hour/session, family intervention for 6 weeks. |
| Wait-list | No intervention | –Subjects will be on waiting list for active intervention and will receive the PAAS intervention at the end of the study (same as active intervention). |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject is of African-American racial status (self-reported)
- Subject can speak and read English
- Subject and parent/legal guardian agree to participate in the 6-week PAAS program
- Subject and parent/legal guardian agree to complete all assessments
- Subject must meet MRI safety eligibility
Key exclusion criteria (9 listed)
- Subject has a major medical problem (e.g. neurological disorders)
- Subject is on medication(s) that affects the central nervous system
- Subject has behavioral/emotional problems at a clinical level (parent and/or youth report)
- Subject is pregnant or suspected of being pregnant (based on pregnancy test)
- Subject is color-blind
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 |
|---|---|---|
| Pathways for African-Americans' Success (PAAS)PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session. | Behavioural | Pathways for African-Americans' Success |
Primary outcome
Changes in Emotional Regulation
Time frame: 18 weeks (from pre-intervention to 3-months after post-intervention)
Emotional regulation was assessed through parent and youth self-reported questionnaires using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). T scores, normed for age and sex are available. T-score standardizes an individual's executive functioning difficulties relative to peers. For example, 50 is the population mean and a standard deviation of 10. Higher scores indicate more significant problems. Scores below 60 are within normal limits; 60-64: subclinical difficulties; 65-69: mildly elevated; 70-74: moderately elevated; and 75 or above: considered highly elevated, suggesting significant difficulties in emotion regulation. These questionnaires were administered at baseline (before intervention) and 3 months post-intervention. Because parent report may be less biased regarding youth's regulation, we used parent data for analysis. Data imputation was done for missing data.
1 secondary outcome
Changes in Cognitive Regulation
Time frame: 18 weeks (from pre-intervention to 3-months after post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Uma Rao, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways for African-Americans' Success (PAAS) in people with Risk-Taking and Adolescent Behavior, run by University of California, Irvine 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 26 Jan 2026. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Emotional Regulation (time frame: 18 weeks (from pre-intervention to 3-months after post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.