- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02764099
Testing a Multilevel Preventive Intervention in Youth Courts
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aggressive, Violent, and Delinquent Behavior at Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Christopher Williams, Ph.D., National Health Promotion Associates
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R34DA034888 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Stofmisbrug
-
Seoul National University Bundang HospitalAktiv, ikke rekrutterendeDrug Drug Interaction (DDI)Sydkorea
-
Theravance BiopharmaAfsluttet
-
Onconic Therapeutics Inc.Rekruttering
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Drug-Drug Interaction (DDI)Det Forenede Kongerige
-
Beijing Union Pharmaceutical Factory LtdIkke rekrutterer endnuDrug Drug Interaction (DDI)Kina
-
SPARK BiopharmaAfsluttetDrug Drug Interaction (DDI)Sydkorea
-
Allyx TherapeuticsNational Institute on Aging (NIA)Aktiv, ikke rekrutterendeDrug Drug Interaction (DDI)Forenede Stater
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Astellas Pharma Europe B.V.AfsluttetSunde emner | Farmakokinetik | Drug-Drug Interaction (DDI)Tyskland
-
Beijing Continent Pharmaceutical Co, Ltd.Ikke rekrutterer endnuDDI (Drug-Drug Interaction) | Kronisk Hepatitis B LeverskleroseKina
Kliniske forsøg med Life Skills Training
-
NLT SpineUkendtDegenerativ diskussygdomIsrael
-
Mazor RoboticsAfsluttetSmerter i lændenTyskland, Israel
-
Ibn Sina HospitalBanon IVF Center Assiut, EgyptAfsluttet
-
Gazi UniversityAfsluttetMotionstræningTyrkiet (Türkiye)
-
Hasselt UniversityTel Aviv University; Sheba Medical Center; Centre Hospitalier Universitaire... og andre samarbejdspartnereAfsluttet
-
Tel Aviv UniversityAfsluttetAttention Deficit Hyperactivity DisorderIsrael
-
Yale UniversityAfsluttetPsykisk helbredsproblem (f.eks. depression, psykose, personlighedsforstyrrelse, stofmisbrug) | Mental sundhed velvære 1 | Krigsrelateret traumeJordan
-
Massachusetts General HospitalRekrutteringPsykotiske lidelser | Stemningsforstyrrelser | AngstlidelserForenede Stater