Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects

January 7, 2026 updated by: Uma Rao, University of California, Irvine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anna Ter-Grigoryan, BS
  • Phone Number: (949) 824-3770
  • Email: tergriga@uci.edu

Study Contact Backup

  • Name: Adriana Pedroza, BA
  • Phone Number: (949) 824-7056
  • Email: apedroz5@uci.edu

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92617
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pathways for African-Americans' Success
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.
Behavioral: 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.
No Intervention: Wait-list
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
18 weeks (from pre-intervention to 3-months after post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Cognitive Regulation
Time Frame: 18 weeks (from pre-intervention to 3-months after post-intervention)
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.
18 weeks (from pre-intervention to 3-months after post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uma Rao, MD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20173439
  • R01DA040966 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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