跳至主要内容
临床试验/NCT02141646
NCT02141646终止不适用

Adolescent Decision Making and HIV Risk Avoidance: Neurocognitive Factors

University of New Mexico1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
280
试验地点
1
主要终点
Change in risky sexual behaviors

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •participating in the youth reporting center;
  • •be aged 14 to 18;
  • •be proficient in English
  • •consent to be re-contacted 3 and 6 months post-intervention;
  • •must have the fully informed consent of a parent or legal guardian;
  • •must give their personal fully informed assent to participate.

排除标准

  • •History of brain injury or brain related medical problems;
  • •Currently on any psychotropic medications (e.g., neuroleptics, anticonvulsants);
  • •Female subjects must not be pregnant (as indicated by a negative pregnancy test on scan day);
  • •fMRI contra-indications (e.g., non-removable metallic implants, claustrophobia).

研究组 & 干预措施

Motivational interviewing

Experimental

干预措施: Motivational Interviewing (Behavioral)

Behavioral skills training

Experimental

干预措施: Behavioral Skills Training (Behavioral)

结局指标

主要结局

Change in risky sexual behaviors

时间窗: Behavioral follow-up measures completed 3 and 6 months post-intervention.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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