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AzTrials

HIV/AIDSDASHNCT02141646

DASH - Decision Making in Adolescent Sexual Health

A study testing Motivational Interviewing and Behavioral Skills Training in people with HIV/AIDS, run by University of New Mexico at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Motivational Interviewing and Behavioral Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
Feb 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

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 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Adolescent Decision Making and HIV Risk Avoidance: Neurocognitive Factors

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).

Read the detailed description
  1. 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.
  1. 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.
  1. 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.
  2. 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.
Conditions
HIV/AIDS
Being tested
Motivational Interviewing, Behavioral Skills Training
Keywords
HIV/AIDS, motivational interviewing, behavioral skills training, MRI
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational InterviewingBehavioural

    The main goals of motivational interviewing are to engage clients, elicit change talk, and evoke motivation to make positive changes from the client.

  • Behavioral Skills TrainingBehavioural

    Behavioral Skills Training (BST) is a training package that utilizes instructions, modeling, rehearsal, and feedback in order to teach a new skill.

Study groups in NCT02141646
Study groupRoleWhat they receive
Motivational interviewingExperimentalNot described
Receives: Behavioral: Motivational Interviewing
Behavioral skills trainingExperimentalNot described
Receives: Behavioral: Behavioral Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in risky sexual behaviors

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2014 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: This research was not conducted at UNM \& not Applicable Clinical Trial.

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02141646
Sponsor's protocol ID
RO1 NR0113332
Acronym
DASH
Status last verified
Mar 2024
First submitted
4 Mar 2014
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • Gibson LP, Gust CJ, Gillman AS, Bryan AD, Feldstein Ewing SW. Mechanisms of Action for Empirically Supported Interventions to Reduce Adolescent Sexual Risk Behavior: A Randomized Controlled Trial. J Adolesc Health. 2020 Jul;67(1):53-60. doi: 10.1016/j.jadohealth.2020.01.004. Epub 2020 Mar 10.

    PubMed 32169523

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing and Behavioral Skills Training in people with HIV/AIDS, run by University of New Mexico 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Mar 2024. 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?

The study was stopped early (reason given: This research was not conducted at UNM \& not Applicable Clinical Trial.). Results are not available in the source record.

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?

Change in risky sexual behaviors (time frame: Behavioral follow-up measures completed 3 and 6 months post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02141646, which also lists 1 linked publication.

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 13 Mar 2024.

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