Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects

• ClinicalTrials.gov Identifier: NCT03370393
• Recruitment Status: Recruiting
• First Posted: December 12, 2017
• Last Update Posted: November 5, 2020
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): Uma Rao, University of California, Irvine

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Risk-Taking; Adolescent Behavior	Behavioral: Pathways for African-Americans' Success (PAAS)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Prevention
• Official Title: Prevention of Adolescent Risky Behaviors: Neural Markers of Intervention Effects
• Actual Study Start Date: December 11, 2017
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
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 AAs, 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).

Outcome Measures

Primary Outcome Measures :

1. Changes in fronto-striatal functional connectivity [ Time Frame: 6 weeks ]
   Changes in fronto-striatal functional connectivity at rest and while performing a probabilistic reward task during an MRI scan from baseline to post-intervention

Secondary Outcome Measures :

1. Changes in emotional regulation [ Time Frame: 3 months post-intervention ]
   Emotional regulation will be assessed through parent and youth self-reported questionnaires, and summary scores will be derived from these questionnaires administered at baseline (before intervention) and 3 months post-intervention
2. Changes in cognitive regulation [ Time Frame: 3 months post-intervention ]
   Cognitive regulation will be assessed through parent and youth self-reported questionnaires, and summary scores will be derived from these questionnaires administered at baseline (before intervention) and 3 months post-intervention

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Contacts

Contact: Anna Ter-Grigoryan, BS; (949) 824-3770; tergriga@uci.edu

Contact: Adriana Pedroza, BA; (949) 824-7056; apedroz5@uci.edu

Locations

United States, California

University of California, Irvine; Recruiting

Irvine, California, United States, 92617

Contact: Anna Ter-Grigoryan, BS 949-824-3770 tergriga@uci.edu

Contact: Adriana Pedroza, BA (949) 824-7056 apedroz5@uci.edu

Principal Investigator: Uma Rao, MD

Sponsors and Collaborators

University of California, Irvine

Investigators

• Principal Investigator: Uma Rao, MD; University of California, Irvine

  Study Documents (Full-Text)

Documents provided by Uma Rao, University of California, Irvine:

Informed Consent Form  [PDF] August 12, 2019

More Information

• Responsible Party: Uma Rao, Professor and Vice Chair, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT03370393
• Other Study ID Numbers: 2017-3439
• First Posted: December 12, 2017
• Last Update Posted: November 5, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uma Rao, University of California, Irvine:

Reward-drive; Cogntiive-control