- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02764099
Testing a Multilevel Preventive Intervention in Youth Courts
Přehled studie
Detailní popis
Adolescents in under-served, urban communities are disproportionately involved in the juvenile justice system. This early engagement has been shown to be a strong predictor of more serious offenses in adulthood, such that youth involvement in the court system is a significant public health concern. Juvenile justice approaches have traditionally emphasized individualized treatment efforts combined with discipline and punishment. More recently, however, juvenile justice professionals have questioned the adequacy of this approach and are increasingly adopting an asset-based perspective referred to as "positive youth justice" (PYJ). The PYJ approach encourages youth court participants to build upon their existing strengths, while learning and mastering new life skills, through development of pro-social relationships within their peer group, family, and community. These "core assets" are posited to promote the successful entry into young adulthood. For this project, the investigative team will adapt and test a multilevel, multi-component, intervention that has strong potential to reduce substance use and delinquency while correspondingly promoting positive youth justice among youth court participants and staff. The first component of the current project involves interviewing program directors from a representative sample of youth courts throughout the U.S to gain formative feedback about logistical and programming concerns. The second component of the project is designed to promote individual-level change among youth participants and consists of an adapted version of the Life Skills Training (LST) program, an evidence-based drug and violence prevention program which teaches personal self-management skills, social skills, drug refusal skills, and other life skills needed to successfully navigate developmental tasks, increase resilience, and facilitate healthy psycho-social development. Several youth courts have used the Life Skills Training program, suggesting that it meets a perceived need and is feasible in this setting. However, LST has never been rigorously tested in the youth court setting. The proposed research will involve a randomized efficacy trial with 560 adolescents in youth court. The investigative team will examine intervention effects on substance use, delinquent behavior, school performance, and recidivism rates using mixed qualitative (assessment of dosage, fidelity, and provider and participant feedback to determine their impact on program efficacy) and quantitative (survey assessments at pretest, post-test, and six-month follow-up) methods to estimate the effect size of the adapted and combined program. By intervening with both youth court participants and youth court staff, the proposed multilevel intervention can have a broad impact on risk and protective factors at multiple levels of influence. The ultimate goal of this research is to promote the use of an evidence-based prevention approach adapted specifically for implementation in youth courts in order to reduce the adverse consequences of drug abuse, violence, and delinquency among youth offenders.
The specific aims of this project will be to:
- Conduct key informant interviews with a diverse sample of youth court program coordinators;
- Conduct expert review of the LST intervention materials to ensure accuracy and appropriateness for the youth court setting and revise appropriately for an efficacy trial;
- Evaluate the efficacy of the combined youth court intervention (staff training plus LST) in preventing substance use, delinquency and violence, improving hypothesized mediators of intervention effects, including knowledge, attitudes and life skills, and promoting effective youth placements in community settings;
- Examine the degree to which process variables such as dosage and fidelity moderate intervention effects;
- Examine all recruitment, incentive, consent, tracking and assessment procedures in preparation for a subsequent national effectiveness trial.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Inclusion criteria for youth participants will include regular participation in youth court activities and informed consent
Exclusion Criteria:
- Exclusion criteria for youth participants will include significant cognitive impairment or severe learning disabilities, as screened by staff at the youth court
- Any previous experience with the intervention program will also exclude adolescents from participating
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Life Skills Training
All youth who consent to participate in the proposed study will 1) complete the youth peer court sanction delivered by the jury of peers (e.g., apologies or essays, restitution, curfew and travel restrictions, counseling, etc.), which will constitute "treatment as usual"; and 2) complete pre, post, and six-month follow-up surveys.
Those randomized to the intervention condition (n=280) will participate in the LST program concurrently during the weeks when they serve as peer court jurors.
|
The Life Skills Training (LST) program is a comprehensive competence enhancement prevention approach that teaches resistance skills while also emphasizing generic personal and social skills training.
The LST program content and skills training is delivered to youth participants by trained providers through instruction, demonstration, behavioral rehearsal with feedback and social reinforcement, extended practice through homework assignments, and didactic teaching methods.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Baseline
Časové okno: Pre-test (prior to participating in the first session of the intervention)
|
Substance Use Behavior and Intentions: For 13 substance-related items (e.g., alcohol, tobacco, cocaine, methamphetamines, steroids), participants will be asked to indicate frequency of use.
Drug Attitudes: Sixteen items will be used to assess participants' attitudes about drug use, perceived characteristics of drug users and the perceived social benefits of drug use.
Drug Norms & Knowledge: Normative expectations related to drug use will be assessed including perceived prevalence of drug use among peers and among adults.
Friends' and adult substance use will be measured.
Drug Refusal Skills will be assessed using five items that measure the ability to resist peer pressure to engage in substance use.
|
Pre-test (prior to participating in the first session of the intervention)
|
|
Change in Baseline Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Post-Intervention
Časové okno: Post-test (within 2 weeks of completing final session of the intervention)
|
Substance Use Behavior and Intentions: For 13 substance-related items (e.g., alcohol, tobacco, cocaine, methamphetamines, steroids), participants will be asked to indicate frequency of use.
Drug Attitudes: Sixteen items will be used to assess participants' attitudes about drug use, perceived characteristics of drug users and the perceived social benefits of drug use.
Drug Norms & Knowledge: Normative expectations related to drug use will be assessed including perceived prevalence of drug use among peers and among adults.
Friends' and adult substance use will be measured.
Drug Refusal Skills will be assessed using five items that measure the ability to resist peer pressure to engage in substance use.
|
Post-test (within 2 weeks of completing final session of the intervention)
|
|
Change in Baseline Substance Use Behavior, Intentions, Attitudes and Perceived Norms at 6-months
Časové okno: 6-month followup (within 6-7 months of completing final session of intervention)
|
Substance Use Behavior and Intentions: For 13 substance-related items (e.g., alcohol, tobacco, cocaine, methamphetamines, steroids), participants will be asked to indicate frequency of use.
Drug Attitudes: Sixteen items will be used to assess participants' attitudes about drug use, perceived characteristics of drug users and the perceived social benefits of drug use.
Drug Norms & Knowledge: Normative expectations related to drug use will be assessed including perceived prevalence of drug use among peers and among adults.
Friends' and adult substance use will be measured.
Drug Refusal Skills will be assessed using five items that measure the ability to resist peer pressure to engage in substance use.
|
6-month followup (within 6-7 months of completing final session of intervention)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Aggressive, Violent, and Delinquent Behavior at Baseline
Časové okno: Pre-test (prior to participating in the first session of the intervention)
|
Aggressive, violent, and delinquent behaviors will be assessed using the items from the Reactive/Proactive Aggression Scale (RPAS).
The RPAS provides respondents with a sequence of aggressive/violent behaviors and prompts them to indicate the frequency of each behavior.
Beliefs about aggressive and violent behavior will be measured using the items from the Normative Beliefs about Aggression Scale (NBAS).
The 20-item NBAS contains 2 sections: retaliation belief questions and general belief questions, which can be tallied to calculate a measure of total approval of aggression.
Delinquent and disciplinary behavioral data will be gathered using the Rochester Youth Development Self-Reported Delinquency Scale, a self-report measure of delinquency and problem behavior developed by the Rochester Youth Development Study.
|
Pre-test (prior to participating in the first session of the intervention)
|
|
Change in Baseline Aggressive, Violent, and Delinquent Behavior at Post-Intervention
Časové okno: Post-test (within 2 weeks of completing final session of the intervention)
|
Aggressive, violent, and delinquent behaviors will be assessed using the items from the Reactive/Proactive Aggression Scale (RPAS).
The RPAS provides respondents with a sequence of aggressive/violent behaviors and prompts them to indicate the frequency of each behavior.
Beliefs about aggressive and violent behavior will be measured using the items from the Normative Beliefs about Aggression Scale (NBAS).
The 20-item NBAS contains 2 sections: retaliation belief questions and general belief questions, which can be tallied to calculate a measure of total approval of aggression.
Delinquent and disciplinary behavioral data will be gathered using the Rochester Youth Development Self-Reported Delinquency Scale, a self-report measure of delinquency and problem behavior developed by the Rochester Youth Development Study.
|
Post-test (within 2 weeks of completing final session of the intervention)
|
|
Change in Baseline Aggressive, Violent, and Delinquent Behavior at 6-months
Časové okno: 6-month followup (within 6-7 months of completing final session of intervention)
|
Aggressive, violent, and delinquent behaviors will be assessed using the items from the Reactive/Proactive Aggression Scale (RPAS).
The RPAS provides respondents with a sequence of aggressive/violent behaviors and prompts them to indicate the frequency of each behavior.
Beliefs about aggressive and violent behavior will be measured using the items from the Normative Beliefs about Aggression Scale (NBAS).
The 20-item NBAS contains 2 sections: retaliation belief questions and general belief questions, which can be tallied to calculate a measure of total approval of aggression.
Delinquent and disciplinary behavioral data will be gathered using the Rochester Youth Development Self-Reported Delinquency Scale, a self-report measure of delinquency and problem behavior developed by the Rochester Youth Development Study.
|
6-month followup (within 6-7 months of completing final session of intervention)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Christopher Williams, Ph.D., National Health Promotion Associates
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R34DA034888 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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