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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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:
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
| Behavioral skills training | Experimental | Not described Receives: Behavioral: Behavioral Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted19 May 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: This research was not conducted at UNM \& not Applicable Clinical Trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah W Feldstein Ewing, Ph.D., Principal investigator, Oregon Health and Science University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Decision Making and HIV Risk Avoidance: Neurocognitive Factors
- ClinicalTrials.gov ID
- NCT02141646
- Acronym / sponsor ID
- DASH / RO1 NR0113332
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, motivational interviewing, behavioral skills training, MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This research was not conducted at UNM \& not Applicable Clinical Trial.
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational Interviewing |
| Behavioral skills training | Experimental | Behavioral: Behavioral Skills Training |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingThe main goals of motivational interviewing are to engage clients, elicit change talk, and evoke motivation to make positive changes from the client. | Behavioural | Motivational interviewing |
| Behavioral Skills TrainingBehavioral Skills Training (BST) is a training package that utilizes instructions, modeling, rehearsal, and feedback in order to teach a new skill. | Behavioural | Behavioral skills training |
Primary outcome
Change in risky sexual behaviors
Time frame: Behavioral follow-up measures completed 3 and 6 months post-intervention.
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 32169523Gibson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah W Feldstein Ewing, Ph.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
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.