Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02141646 |
| Other study ID # |
RO1 NR0113332 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2012 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
March 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a randomized controlled trial to contrast an intervention that relies on
well-developed cognitive control systems (Motivational Interviewing; MI) to an intervention
that relies on a more basic response to scheduled reward (Behavioral Skills Training; BST).
Description:
I. Research Project Title: Adolescent decision making and HIV risk avoidance: Neurocognitive
factors (Referred to as: "Project DASH")
II. Investigator name, degree, title and department: PI: Sarah Feldstein Ewing, PhD
(primary), Assistant Professor University Honors/ CASAA/ MRN, the Mind Research Network;
Angela Bryan, PhD, (secondary), Research Professor, MRN/Psychology/CASAA
III. Hypothesis/Study Goals (questions hoped to be answered by study)
Young people under the age of 25 are at great risk for sexually transmitted diseases (STDs)
including the human immunodeficiency virus (HIV; Centers for Disease Control and Prevention
(CDC, 2002). Indeed 50% of all new HIV infections worldwide occur among young people between
the ages of 15 and 24 (Wilson et al., 2010). Young people involved with the juvenile justice
system (Teplin, Mericle, McClelland & Abram, 2003) are at particularly high risk for negative
outcomes including HIV as a result of risky sexual behavior. In comparison to the general
adolescent population, adolescents involved with the justice system are younger at first
intercourse, have higher rates of anal intercourse, a greater number of sex partners, and
lower rates of condom use (Barthlow, Horan, DiClemente, & Lanier; 1995; DiClemente, 1991;
1992; Lux & Petosa, 1994, 1995; Montanaro et al., 2010). Extensive research indicates that
development of regions of the brain important in decision-making regarding risky situations
(e.g., OFC, Ursu & Carter, 2005; ventral striatum, Van Leijenjorst et al., 2010; IFG, Luna et
al., 2010, Aron et al., 2003; Chamberlain & Sahakian, 2007; VM-PFC, Bechara, 2004; ACC,
Rueda, Posner, & Rothbart, 2005) is still occurring during adolescence (e.g., RFA-NR-11-007;
Van Leijenjorst et al., 2010; Galvan et al., 2006; Casey et al., 2005; 2000). Our own work
has demonstrated that neurocognitive networks including these important brain regions are
associated both with sexual risk and response to an HIV/STD risk reduction intervention.
Additionally, it is clear that while current interventions to reduce risky sexual
decision-making and behavior work well, they are not equally effective for everyone. Many
existing interventions, including our own (Bryan et al., 2009), rely on high level cognition.
The effectiveness of these interventions is thus likely to be moderated by developmental and
individual differences in neurocognition that underlie decision-making under conditions of
arousal and risk. It stands to reason, then, that a more basic, reward-based intervention
that does not rely so heavily on what are likely underdeveloped systems of cognitive control
(e.g., impulsivity) might be more successful for those adolescents with less developed
neurocognitive control networks.
While the neuronal mechanisms that underlie risky decision-making have been studied in the
laboratory, few have translated these basic findings in an integrative program of research
that links these mechanisms with intervention outcomes. Consistent with the NINR RFA
"Interdisciplinary Approaches for HIV/AIDS Risk-Avoidance Decision Making in Developing
Adolescence", this application seeks to test two different types of interventions as "a
better understanding of the role of psychosocial predictors and neurological biomarkers of
adolescent risk taking…can lead to alternative developmentally and culturally appropriate
interventions…." In following, we will employ a randomized controlled trial to contrast an
intervention that relies on well-developed cognitive control systems (Motivational
Interviewing; MI) to an intervention that relies on a more basic response to scheduled reward
(Behavioral Skills Training; BST). The most innovative aspects of the proposed research are
the integrative model linking neurocognitive, psychological, and developmental constructs
involved in risk behavior, the use of fMRI to assess neurocognitive moderators of
intervention effects, and the potential for translation of these findings to practice via
their linkage to easily-administered, computerized cognitive tasks.
To accomplish this, we propose these specific aims:
1. The first aim is to demonstrate associations between the function of reward and control
networks in the brain and risky sexual behavior.
• Hypothesis 1. Consistent the extant literature (e.g., Van Leijenhorst et al., 2010;
Bjork et al., 2004), we expect that decreased activation in the control networks and
increased activation in the reward networks of the brain will be associated with higher
levels of risky sexual behavior.
2. The second aim is to understand whether variability in neurocognitive activation
associated with the control and reward systems predicts the effectiveness of the two
commonly used interventions: an individually-based MI intervention and an
individually-based BST intervention to reduce risky sexual behavior among
justice-involved adolescents at high risk for HIV/STDs.
- Hypothesis 2. Adolescents with increased activation in the control networks in the
brain during a task associated with response inhibition (Go/NoGo) will respond
better to the MI intervention than adolescents with decreased activation in these
areas.
- Hypothesis 3. Adolescents with increased activation in the reward networks in the
brain during a task associated with reward salience (Monetary Incentive Delay; MID)
will respond better to the BST intervention than adolescents with decreased
activation in these areas.
3. The third aim is to examine the correlation between neurocognitive responses to the
fMRI-based response inhibition and reward based tasks to a parallel set of cognitive
tasks that are easily administered outside of the scanner (e.g., Conners' Continuous
Processing Task; Monetary Incentive Delay) to assess the potential for the translation
of neurocognitive findings into real-world application.
4. To determine whether a specific genetic factor, previously related to psychosocial
treatment response, is associated with differential brain activation and intervention
response.
- Hypothesis 4: Individuals with the DRD4 S genotype will evidence greater activation
in key brain regions in response to MI (e.g., IFG, insula), as compared to those
who receive BST.
