Drug AbuseNCT02764099
Testing a Multilevel Preventive Intervention in Youth Courts
A study testing Life Skills Training in people with Drug Abuse, run by National Health Promotion Associates, Inc..
Trial summary
The proposed research is designed to adapt and test an evidence-based drug abuse prevention approach for use in youth courts among first-time, non-violent, adolescent offenders. The ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug abuse, violence, and delinquency. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Life Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2018
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria for youth participants will include regular participation in youth court activities and informed consent
Who cannot join
- 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
About this study
The proposed research is designed to adapt and test an evidence-based drug abuse prevention approach for use in youth courts among first-time, non-violent, adolescent offenders. The ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug abuse, violence, and delinquency. Planned project activities include conducting: 1) key informant interviews of youth court directors regarding logistical and intervention features of effective youth court programming; and, 2) a randomized controlled efficacy trial of an adapted version of Life Skills Training, an evidence-based drug and violence prevention program. It is anticipated that the findings will provide critical information on implementing evidence-based prevention programs for new populations and settings and will support preparations for a large-scale effectiveness trial in youth peer courts.
Read the detailed description
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.
- Conditions
- Drug Abuse
- Being tested
- Life Skills Training
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Skills TrainingBehavioural
Also called LST
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.
| Study group | Role | What they receive |
|---|---|---|
| Life Skills Training | Experimental | 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. Receives: Behavioral: Life Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Baseline
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.
Measured: 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
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.
Measured: 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
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.
Measured: 6-month followup (within 6-7 months of completing final session of intervention)
Secondary outcomes (3)
Aggressive, Violent, and Delinquent Behavior at Baseline
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.
Measured: Pre-test (prior to participating in the first session of the intervention)
Change in Baseline Aggressive, Violent, and Delinquent Behavior at Post-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.
Measured: Post-test (within 2 weeks of completing final session of the intervention)
Change in Baseline Aggressive, Violent, and Delinquent Behavior at 6-months
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.
Measured: 6-month followup (within 6-7 months of completing final session of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Promotion Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Christopher Williams, National Health Promotion Associates, Inc.
- Investigators
- Christopher Williams, Ph.D., Principal investigator, National Health Promotion Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764099
- Sponsor's protocol ID
- R34DA034888
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2015
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Multilevel Preventive Intervention in Youth Courts
- ClinicalTrials.gov ID
- NCT02764099
- Acronym / sponsor ID
- R34DA034888
- Conditions
- Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- National Health Promotion Associates, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 May 2016 (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.
The proposed research is designed to adapt and test an evidence-based drug abuse prevention approach for use in youth courts among first-time, non-violent, adolescent offenders. The ultimate goal is to reduce the adverse health, legal, and social consequences of youth drug abuse, violence, and delinquency. Planned project activities include conducting: 1) key informant interviews of youth court directors regarding logistical and intervention features of effective youth court programming; and, 2) a randomized controlled efficacy trial of an adapted version of Life Skills Training, an evidence-based drug and violence prevention program. It is anticipated that the findings will provide critical information on implementing evidence-based prevention programs for new populations and settings and will support preparations for a large-scale effectiveness trial in youth peer courts.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Life Skills Training | Experimental | Behavioral: Life Skills TrainingAll 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria for youth participants will include regular participation in youth court activities and informed consent
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Life Skills TrainingAlso: LSTThe 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. | Behavioural | Life Skills Training |
Primary outcome
Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Baseline
Time frame: 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.
Change in Baseline Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Post-Intervention
Time frame: 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.
Change in Baseline Substance Use Behavior, Intentions, Attitudes and Perceived Norms at 6-months
Time frame: 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.
3 secondary outcomes
Aggressive, Violent, and Delinquent Behavior at Baseline
Time frame: Pre-test (prior to participating in the first session of the intervention)
Change in Baseline Aggressive, Violent, and Delinquent Behavior at Post-Intervention
Time frame: Post-test (within 2 weeks of completing final session of the intervention)
Change in Baseline Aggressive, Violent, and Delinquent Behavior at 6-months
Time frame: 6-month followup (within 6-7 months of completing final session of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Christopher Williams, Ph.D. principal investigator
National Health Promotion Associates
Questions about this trial
What is this clinical trial studying?
A study testing Life Skills Training in people with Drug Abuse, run by National Health Promotion Associates, Inc..
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Substance Use Behavior, Intentions, Attitudes and Perceived Norms at Baseline (time frame: Pre-test (prior to participating in the first session of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.