Project MARS: Design of a Multi-Behavior Intervention Trial for Justice-Involved Youth.
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ABSTRACT: Background
Marijuana and alcohol use are associated with increased sexual risk behavior among justice-involved youth. A multi-behavior intervention may reduce all three risk behaviors.Purpose
To examine the relationships among multiple risk behaviors and the Theory of Planned Behavior (TPB) constructs guiding the development of the MARS (Motivating Adolescents to Reduce Sexual risk) intervention. We describe the MARS study design to inform the process through which a multi-behavior intervention trial can be implemented and evaluated.Methods
Participants completed questionnaires prior to randomization to one of three interventions.Results
Relationships were found between TPB constructs and risk behavior. A single latent variable was inadequate to capture all three risk behaviors.Conclusions
Interventions to reduce sexual risk behavior can include content related to the role of substance use in influencing sexual risk behavior with only minimal modifications to the curriculum, and preliminary data suggest a common theory can apply across risk behaviors.
SUBMITTER: Callahan TJ
PROVIDER: S-EPMC3583233 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionJustice-involved adolescents are at high risk for sexually transmitted infections; one primary reason is co-occurring substance use. This study investigates the additive benefit of including alcohol and cannabis use content in a theory-based sexual risk reduction intervention, delivered using group-based motivational enhancement therapy.Study designThis study had a cluster randomized design, with randomization of single-sex clusters to 1 of 3 interventions.Setting/participantsParticipants were male and female justice-involved adolescents (N=460) residing in youth detention facilities. Data were collected from 2010 to 2014; analyses were completed in 2018-2019.InterventionAdolescents were randomized to 1 of 3 motivational enhancement therapy interventions: sexual risk reduction intervention, sexual risk reduction intervention with alcohol content, or sexual risk reduction intervention with alcohol and cannabis content.Main outcome measuresThe primary outcome was risky sexual behavior (aggregation of condom use and frequency of intercourse), measured every 3 months for 1 year. Secondary outcomes were theoretical mechanisms on which the intervention was based (condom use attitudes, self-efficacy, peer norms, and behavioral intentions), collected at baseline and post-test.ResultsRisky sexual behavior significantly decreased from baseline to 3-month follow-up (t=10.59, p<0.001) and this decrease was maintained 1 year later (t=9.04, p<0.001). Intervention was associated with improved values on all theoretical mechanisms. Although all outcomes improved over time, changes did not differ by intervention condition (p>0.29 for all). Comparisons to a historical, information-only, sexual risk reduction control arm conducted with a similar juvenile justice sample confirm the effectiveness of all 3 motivational enhancement therapy-based interventions.ConclusionsAll 3 interventions were associated with decreased sexual risk up to 1 year later, suggesting that the intervention modality (motivational enhancement therapy) may resonate with this population beyond the specific substance use content. This single-session manualized intervention can be readily disseminated to juvenile justice settings.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01170260.
| S-EPMC7755031 | biostudies-literature
Project description:HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe.Thirty rural communities were randomized to early or deferred implementation of the intervention in 2003. Impact was assessed in a representative survey of 18-22-year-olds after 4 years. Participants self-completed a questionnaire and gave a dried blood spot sample for HIV and herpes simplex virus-2 (HSV-2) antibody testing. Young women had a urinary pregnancy test. Analyses were by intention-to-treat and were adjusted for clustering.Four thousand six hundred and eighty-four, 18-22-year-olds participated in the survey (97.1% of eligible candidates, 55.5% women). Just over 40% had been exposed to at least 10 intervention sessions. There were modest improvements in knowledge and attitudes among young men and women in intervention communities, but no impact on self-reported sexual behavior. There was no impact of the intervention on prevalence of HIV or HSV-2 or current pregnancy. Women in intervention communities were less likely to report ever having been pregnant.Despite an impact on knowledge, some attitudes, and reported pregnancy, there was no impact of this intervention on HIV or HSV-2 prevalence, further evidence that behavioral interventions alone are unlikely to be sufficient to reverse the HIV epidemic. The challenge remains to find effective HIV prevention approaches for young people in the face of continued and unacceptably high HIV incidence, particularly among young women.
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Project description:Background Juvenile justice (JJ) youth are at high risk of opioid and other substance use (SU), dysfunctional family/social relationships, and complex trauma. The purpose of the Leveraging Safe Adults (LeSA) Project is to examine the effectiveness of Trust-Based Relational Intervention® (TBRI®; leveraging family systems by providing emotional and instrumental guidance, support, and role modeling) in preventing opioid and other SU among youth after release from secure residential facilities. Methods An effectiveness-implementation Hybrid Type 1 design is used to test the effectiveness of TBRI for preventing non-medical use of opioids among JJ-youth (delayed-start at the site level; a randomized controlled trial at participant level) and to gain insight into facility-level barriers to TBRI implementation as part of JJ re-entry protocols. Recruitment includes two samples (effectiveness: 360 youth/caregiver dyads; implementation: 203 JJ staff) from nine sites in two states over 3 years. Participant eligibility includes 15 to 18-year-olds disposed to community supervision and receiving care in a secure JJ facility, without active suicide risk, and with one caregiver willing to participate. Effectiveness data come from (1) youth and caregiver self-report on background, SU, psychosocial functioning, and youth-caregiver relationships (Months 0, 3, 6, 12, and 18), youth monthly post-release check-ins, and caregiver report on youth psychological/behavioral symptoms, and (2) JJ facility records (e.g., recidivism, treatment utilization). Fidelity assessment includes post-session checklists and measures of TBRI strategy use. Collected four times over four years, implementation data include (1) JJ staff self-report on facility and staff characteristics, use of trauma-informed care and TBRI strategies, and (2) focus groups (line staff, leadership separately) on use of trauma-informed strategies, uptake of new interventions, and penetration, sustainment, and expansion of TBRI practices. Discussion The LeSA study is testing TBRI as a means to empower caregivers to help prevent opioid use and other SU among JJ-youth. TBRI’s multiple components offer an opportunity for caregivers to supplement and extend gains during residential care. If effective and implemented successfully, the LeSA protocol will help expand the application of TBRI with a wider audience and provide guidance for implementing multi-component interventions in complex systems spanning multiple contexts. Trial registration ClinicalTrials.govNCT04678960; registered November 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04678960.
| S-EPMC8605598 | biostudies-literature
Project description:BACKGROUND:The encouragement of healthy lifestyles for obesity prevention in young people is a public health priority. The European Youth Tackling Obesity (EYTO) project is a multicentric intervention project with participation from the United Kingdom, Portugal, the Czech Republic and Spain. The general aim of the EYTO project is to improve lifestyles, including nutritional habits and physical activity practice, and to prevent obesity in socioeconomically disadvantaged and vulnerable adolescents. The EYTO project works through a peer-led social marketing intervention that is designed and implemented by the adolescents of each participating country. Each country involved in the project acts independently. This paper describes the "Som la Pera" intervention Spanish study that is part of the EYTO project. METHODS/DESIGN:In Spain, the research team performed a cluster randomised controlled intervention over 2 academic years (2013-2015) in which 2 high-schools were designated as the control group and 2 high-schools were designated as the intervention group, with a minimum of 121 schoolchildren per group. From the intervention group, 5 adolescents with leadership characteristics, called "Adolescent Challenge Creators" (ACCs), were recruited. These 5 ACCs received an initial 4 h training session about social marketing principles and healthy lifestyle theory, followed by 24 sessions (1.30 h/session) divided in two academic years to design and implement activities presented as challenges to encourage healthy lifestyles among their peers, the approximately 180-200 high-school students in the intervention group. During the design of the intervention, it was essential that the ACCs used the 8 social marketing criteria (customer orientation, behaviour, theory, insight, exchange, competition, segmentation and methods mix). The expected primary outcomes from the Spanish intervention will be as follows: increases in the consumption of fruits and vegetables and physical activity practice along with reductions in TV/computer/game console use. The secondary outcomes will be as follows: increased breakfast consumption, engagement with local recreation and reduced obesity prevalence. The outcomes will be measured by the Health Behaviour in School-aged Children Study (HBSC) survey at baseline and at the end of the intervention. In the control group, no intervention was implemented, but the outcome measurements were collected in parallel with the intervention group. DISCUSSION:This study described a new methodology to improve lifestyles and to address adolescent obesity. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02157402. Registered 03 June 2014.
| S-EPMC4490735 | biostudies-literature
Project description:Justice-involved youth experience high rates of adverse childhood experiences (ACEs), placing them in great need of behavioral health treatment and risk for continued justice involvement. Policymakers, government agencies, and professionals working with justice-involved youth have called for trauma-informed juvenile justice reform. Yet, there is currently no available review of the literature on ACEs and their impact on justice-involved youths' psychological, legal, and related (e.g., academic) outcomes to rigorously guide such reform efforts. The current systematic scoping review synthesizes existing literature related to the impact of ACEs on justice-involved youth and offers recommendations for data-driven intervention along the Sequential Intercept Model, which describes five different points of justice system contact (i.e., first arrest, court diversion, detention, and community supervision) in which there is opportunity to intervene and improve youth behavioral health, legal, and associated outcomes. Eight unique studies were included in 40 articles examining ACEs among justice-involved youth; 38% were longitudinal or prospective analyses and none were intervention studies. Studies included delinquency (e.g., recidivism; n = 5), psychiatric (n = 4), substance use (n = 3), and other (n = 2; e.g., academic, pregnancy) outcomes, documenting high prevalence of ACEs and significant associations between ACEs and a variety of outcomes. Implications for clinical services (e.g., targeting youth dysregulation and aggression), agency context (e.g., training police officers in trauma-responsive practices), and system-level changes (e.g., intervening at the time of first ACE documentation such as parent's arrest) are discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
| S-EPMC8281579 | biostudies-literature
Project description:Black youth account for the largest number of new HIV infections among heterosexual youth. Mental illness and difficulties in emotion regulation contribute to increased reports of HIV/sexually transmitted infection (STI) risk-related sexual behaviors in this group. Yet limited interventions exist to address this affective component of the sexual decision-making process. The purpose of this paper was to describe the trial design, research challenges, and baseline characteristics from a study designed to fill this gap. Project GOLD was a pilot randomized controlled trial of a psychoeducational HIV/STI prevention intervention designed to address the role of mental illness and emotion regulation in HIV/STI risk among heterosexually-active Black youth aged 14 to 17 (N = 108). Challenges encountered in the research process warrant further attention in future research (e.g., disagreement among the regulatory bodies on parental permission requirements). The most common mental health diagnoses were Recurrent Major Depressive Disorder (15.7%) and current substance abuse (7.4%). Participants reported higher levels of emotional suppression, and adaptive methods of emotion management, than culturally inappropriate expressions of anger or sadness. They also reported a mean age of 13.6 at first vaginal sex, used condoms 66% of the time for vaginal sex, and had an average of three sexual partners in the past 6 months. More than one-quarter (26.9%) had sex with more than one person in the same day. These findings indicate intervention is crucial for this population. The forthcoming trial evaluation will indicate the promise of such interventions in reducing HIV/STI infections in this key population.
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Project description:To assess the effect of a multi-component primary care delivered brief intervention for reducing risky psychoactive drug use (RDU) among patients identified by screening.Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated.Primary care waiting rooms of five federally qualified health centers in Los Angeles County (LAC), USA.A total of 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4-26) on the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet computers. 261 (78%) completed follow-up. Mean age was 41.7?years; 62.9% were male; 37.7% were Caucasian.Intervention patients received brief (typically 3-4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet and up to two 20-30-minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up.Intervention and control patients reported equivalent baseline HSD use at 3-month follow-up. After adjustment for covariates, in the complete sample linear regression model, intervention patients used their HSD on 3.5 fewer days in the previous month relative to controls (P<0.001), and in the completed sample model, intervention patients used their HSD 2.2 fewer days than controls (P?<?0.005). No compensatory increases in use of other measured substances were found.A primary-care based, clinician-delivered brief intervention with follow-up coaching calls may decrease risky psychoactive drug use.
| S-EPMC4948983 | biostudies-literature
Project description:BACKGROUND:Youth involved in the juvenile justice system (YIJJ) have high rates of substance use problems; however, rates of YIJJ engagement in substance use services is low. Barriers to service engagement include lack of appropriate screening and connection to services by the juvenile justice system, as well as lack of resources for delivering evidence-based treatment in community-based settings. To address these barriers, this paper describes a protocol for a type 1 hybrid design to (1) implement universal substance use screening for YIJJ; (2) implement and evaluate the feasibility and effectiveness of a brief, three-session substance use interventions based in motivational interviewing for youth with mild/moderate substance use: Teen Intervene (an individual-based intervention); (3) implement ENCOMPASS, an evidence-based substance use intervention based in motivational enhancement and cognitive behavioral therapy for youth with severe substance use; and (4) evaluate facilitators and barriers to implementing these interventions for mild to severe substance use among YIJJ in community mental health centers (CMHC). METHODS/DESIGN:Using a hybrid type 1 clinical effectiveness-implementation design, we will collaborate with CMHCs and juvenile justice in two rural Indiana counties. Guided by the EPIS (exploration, preparation, implementation, sustainability) framework, we will measure factors that affect implementation of substance use screening in juvenile justice and implementation of substance use interventions in CMHCs utilizing self-reports and qualitative interviews with juvenile justice and CMHC staff pre- and post-implementation. YIJJ with mild/moderate substance use will receive a brief interventions and YIJJ with severe substance use will receive ENCOMPASS. We will measure the effectiveness of a brief and comprehensive intervention by assessing changes in substance use across treatment. We anticipate recruiting 160 YIJJ and their caregivers into the study. We will assess intervention outcomes utilizing baseline, 3-, and 6-month assessments. DISCUSSION:Findings have the potential to improve screening and intervention services for YIJJ.
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Project description:Empathy shapes the landscape of our social lives. It motivates prosocial and caregiving behaviors, plays a role in inhibiting aggression, and facilitates cooperation between members of a similar social group. Thus, empathy is often conceived as a driving motivation of moral behavior and justice, and as such, everyone would think that it should be cultivated. However, the relationships between empathy, morality, and justice are complex. We begin by explaining what the notion of empathy encompasses and then argue how sensitivity to others' needs has evolved in the context of parental care and group living. Next, we examine the multiple physiological, hormonal, and neural systems supporting empathy and its functions. One troubling but important corollary of this neuro-evolutionary model is that empathy produces social preferences that can conflict with fairness and justice. An understanding of the factors that mold our emotional response and caring motivation for others helps provide organizational principles and ultimately guides decision-making in medical ethics.
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Project description:Randomized, double-blinded, placebo-controlled trials have significant impact on clinical practice. The ultimate goal of a clinical trial of therapy for acute ischemic stroke (AIS) is to compare 2 interventions. Challenges may include interventional therapy standardization, enrollment rate, patient selection, biases, data and safety monitoring, reporting, and financial and logistical support.Selected randomized and single-arm prospective AIS trial designs. Clinical trial elements and their challenges are reviewed. Innovative designs and proposed recommendations to overcome some of the specific challenges and limitations are discussed.AIS therapy trials have specific challenges related to ethical issues, enrollment rate, outcome measures, limited time to treatment, efficacy, safety, and limited or variable operator experience with complex technology in a delicate end organ. Proposed suggestions for improving trial design include the following: incorporation of a lead-in phase; careful patient and outcome measure selection; historical, concurrent, or hybrid controls; open data access; and a Bayesian approach. An open data paradigm may facilitate creation of computerized prediction models for future trials (minimizing cost by decreasing sample size or providing futility analyses and directing resources to other trials). Collaborative, consortium, and network infrastructures may allow more effective and efficient study completion. Self-learning, self-correcting trials with intrinsic flexibility to adapt may help future clinical trial design in AIS.The randomized clinical trial design in AIS endovascular therapy is challenging. Lead-in phases, careful patient selection, use of innovative outcome measures, control groups, and newer clinical trial design may enhance conduct of future trials, their validity, and their results.
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