Substance AbuseCYDS IVNCT01088542
The Community Youth Development Study: A Test of Communities That Care
A study testing Communities That Care in people with Substance Abuse and Juvenile Delinquency, run by University of Washington at 1 site in United States.
Trial summary
The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Juvenile Delinquency, Sexual Behavior
- What is being tested?
- Communities That Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52,323 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2003to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident at baseline in one of the 24 participating communities
- Student in the Class of 2011 panel sample or in grades 6, 8, 10, or 12 during a survey year
- Community leader or prevention service provider in one of the participating communities
Who cannot join
- Unable to read and comprehend consent materials and/or survey questions in either english or spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
The Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.
Read the detailed description
Preventing alcohol, tobacco, and other drug use; delinquency; violence; and health-risking sexual behavior among adolescents is a national priority. While advances in prevention science over the past two decades have produced a growing list of tested and effective programs and policies for preventing these behaviors, widespread dissemination and high-quality implementation of these effective programs and policies in communities has not been achieved. The development and testing of approaches for translating prevention research findings into effective community prevention service systems with long-term impact is important to achieving reductions in the prevalence of adolescent health and behavior problems that are sustained into adulthood.
The Community Youth Development Study (CYDS) is a community-randomized trial of the effects of Communities That Care (CTC) on community prevention systems and adolescent risk, protection, and behavioral health outcomes. The current continuation study is evaluating the long-term effects of CTC on a panel of 4,407 young adults at ages 21 and 23 who have been surveyed regularly since the trial started when they were in grade 5.
CTC is a prevention planning and capacity building system for improving behavioral health problems among youth community-wide. CTC guides communities to implement with fidelity and monitor the results of effective prevention programs that address community-specific elevated risk factors and depressed protective factors and reduce problem behavior. The CTC system is hypothesized first to produce improvements in key characteristics of community prevention service systems, which, in turn, reduce community levels of risk, increase protective factors, and lower rates of youth problem behaviors.
The CYDS communities were matched in pairs within state, on population size, racial and ethnic diversity, economic indicators, and crime rates. One community from each matched pair was assigned randomly by a coin toss to either the intervention or control condition. Starting in 2003, intervention communities received training, technical assistance, and materials and funding needed to install the CTC prevention system in years 2-5 (2004-2008), hire a community coordinator, and implement 2-5 tested preventive interventions. Selected interventions addressed local prevention priorities established by communities after reviewing local epidemiological data on youth risk factors, protective factors and problem behaviors. Control communities received no training or technical assistance from the study. Technical assistance and study-provided funding to intervention communities ended after 5 years.
The initial CYDS trial (2003-2008) evaluated the efficacy of CTC in reducing levels of risk, increasing levels of protection, and reducing levels of drug use and other problem behaviors in adolescents from Grades 5 through 9. It also tested the effects of CTC on prevention service system transformation (e.g., increases in a science-based approach to prevention, collaboration among prevention service organizations, support for prevention, community norms against drug use and delinquency, and use of the Social Development Strategy to guide interactions with youth) as reported by key community leaders and members of CTC coalitions.
The first continuation study (2009-2013) assessed the effects of installation and implementation of CTC when panel youth were in Grades 10 through Age 19. During this period, panel youth passed through high school, the developmental period of greatest risk for delinquent and violent behavior, and a period of greatly increasing substance use and problems related to substance use. The study evaluated the long-term effects of CTC on adolescent and young adult risk and problem behaviors, including primary outcomes of substance use and abuse, delinquency, crime, and violence. It also evaluated the sustainability of the CTC prevention system without the study-provided funding and support that were offered during the implementation of CTC in the 12 intervention communities during the initial efficacy trial.
The second continuation study (2013-2017) investigated the long-term effects of CTC on young adult substance use and misuse, crime, violence, and incarceration 11 and 13 years following CTC's initial installation. It also evaluated possible effects on a number of secondary outcomes salient in young adulthood, including HIV/AIDS sexual risk behavior, depression and suicidality, anxiety and other mental health disorders, and educational attainment. Panel youth were surveyed twice during the study, at ages 21 and 23.
The third continuation study (2018-2023) further investigates the long-term effects of CTC on the study's primary outcomes of substance use and misuse, crime, violence, and incarceration 16 and 18 years after CTC was installed in intervention communities. As in the prior continuation, it will also evaluate possible long-term effects on salient secondary outcomes, including HIV/AIDS sexual risk behavior, depression and suicidality, anxiety and other mental health disorders, and educational attainment. Another major aim of this study is to examine the normative and legal environment around marijuana use in the U.S., which is becoming more permissive, raising concern that it will increase youth and young adult marijuana and other drug use and associated negative consequences including addiction. Understanding how marijuana use norms and behaviors in multiple social contexts (e.g., peer, family, and community) interact with the legal marijuana context and impact drug use behavior from age 11 to 28 will assist in the identification of malleable targets for interventions and public health approaches to prevent the possible negative outcomes of increasing permissiveness towards marijuana use. Panel participants will be surveyed twice, at ages 26 and 28.
- Conditions
- Substance Abuse, Juvenile Delinquency, Sexual Behavior, Criminal Behavior, Violence, Depression
- Being tested
- Communities That Care
- Keywords
- substance use, delinquency, risky sexual behavior, risk factors, protective factors, prevention, community coalitions, systems transformation, violence
- Medical subject headings
- Substance-Related Disorders, Sexual Behavior, Criminal Behavior, Depression, Anxiety Disorders, Suicide, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communities That CareBehavioural
The Communities That Care (CTC) system provides communities training and ongoing technical assistance in a structured process for conducting prevention needs assessments using epidemiological data on levels of risk and protective factors for adolescent problem behaviors, selection of tested and effective preventive interventions shown to address community-prioritized factors, implementation of these interventions with fidelity, and evaluation of the community's progress toward its goals. The CTC system is designed to produce a plan for prevention services that is tailored to the needs of each community. CTC is installed in five phases through a manualized series of training events designed to build the capacity of communities to install and sustain the system over time.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Communities in the no intervention arm received no intervention from the project and continued to implement prevention services as usual. |
| Communities That Care Intervention | Experimental | Communities randomly assigned to the experimental condition received 5 years of training and technical assistance (from 2003 to 2008) to implement the Communities That Care (CTC) prevention system in their communities. They also received 5 years of funding to support a full-time community coordinator and 4 years of seed money to implement tested and effective prevention programs selected as a result of their CTC process. Receives: Behavioral: Communities That Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted risk and protective factors, substance use, delinquency, violence
Surveys of the panel starting in 5th grade (2004) and continuing in grades 6-10, grade 12, and at ages 19, 21, and 23 are used to assess the impact of the intervention on risk and protective factors targeted by communities, substance use, delinquency, and violence. Cross-sectional surveys of all youth in grades 6, 8, 10, and 12 in all participating communities, conducted every 2 years from 2002 through 2012, are also used to assess the impact of the intervention on these primary outcomes.
Measured: Baseline through thirteen-year follow-up (age 23)
CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation
Structured telephone interviews with key community leaders, CTC coalition members, and prevention services providers (Community Key Informant Survey, Coalition Board Interview, Community Resource Documentation Survey) conducted in 2001-02, 2004-05, 2007-08, 2009-10, and 2011-12 are used to assess intervention effects on CTC coalition functioning, prevention system transformation, and evidence-based prevention program implementation.
Measured: Baseline through eight-year follow-up (age 18)
Secondary outcomes (1)
Substance use disorder, depression and generalized anxiety disorder, sexual risk behavior
Secondary outcomes salient in late adolescence and young adulthood were added to the self-report longitudinal survey beginning at the nine-year follow-up (age 19).
Measured: Nine- through thirteen-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study start1 Oct 2003
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 52,323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Margaret Kuklinski, University of Washington
- Investigators
- Margaret Kuklinski, Ph.D., Principal investigator, University of WashingtonSabrina Oesterle, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088542
- Sponsor's protocol ID
- STUDY00000692
- Other IDs
- R01DA044522
- Acronym
- CYDS IV
- Status last verified
- Feb 2025
- First submitted
- 15 Mar 2010
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We support the goal of making datasets available to researchers in a timely manner to expedite translation of research results into knowledge, products, and procedures to improve human health. With these goals in mind, we have entered into data-sharing collaborations many times with outside researchers. To ensure that the use of these data stay within the legal and ethical constraints of the consent agreement under which they were collected, we have developed a Fair Use Agreement, available upon request, that is signed by the Principal Investigator, Dr. Kuklinski, and by the collaborating researcher when agreement has been reached to share study data. As part of the Fair Use Agreement, we ask researchers to abide by the same Data and Safety Monitoring Plan (DSMP) that we adhere to. We will continue to share data with other researchers who meet the terms of our Fair Use Agreement (and DSMP) and share our strong commitment to protection of the rights and privacy of study participants.
Publications
Oesterle S, Kuklinski MR, Hawkins JD, Skinner ML, Guttmannova K, Rhew IC. Long-Term Effects of the Communities That Care Trial on Substance Use, Antisocial Behavior, and Violence Through Age 21 Years. Am J Public Health. 2018 May;108(5):659-665. doi: 10.2105/AJPH.2018.304320. Epub 2018 Mar 22.
PubMed 29565666Rhew IC, Oesterle S, Coffman D, Hawkins JD. Effects of Exposure to the Communities That Care Prevention System on Youth Problem Behaviors in a Community-Randomized Trial: Employing an Inverse Probability Weighting Approach. Eval Health Prof. 2018 Jun;41(2):270-289. doi: 10.1177/0163278718759397. Epub 2018 Feb 20.
PubMed 29463119Oesterle S, Hawkins JD, Kuklinski MR, Fagan AA, Fleming C, Rhew IC, Brown EC, Abbott RD, Catalano RF. Effects of Communities That Care on Males' and Females' Drug Use and Delinquency 9 Years After Baseline in a Community-Randomized Trial. Am J Community Psychol. 2015 Dec;56(3-4):217-28. doi: 10.1007/s10464-015-9749-4.
PubMed 26377418Rhew IC, Hawkins JD, Murray DM, Fagan AA, Oesterle S, Abbott RD, Catalano RF. Evaluation of Community-Level Effects of Communities That Care on Adolescent Drug Use and Delinquency Using a Repeated Cross-Sectional Design. Prev Sci. 2016 Feb;17(2):177-87. doi: 10.1007/s11121-015-0613-4.
PubMed 26462492Gloppen KM, Brown EC, Wagenaar BH, Hawkins JD, Rhew IC, Oesterle S. Sustaining Adoption of Science-based Prevention Through Communities That Care. J Community Psychol. 2016 Jan;44(1):78-89. doi: 10.1002/jcop.21743. Epub 2015 Dec 18. No abstract available.
PubMed 27397946Kim BK, Gloppen KM, Rhew IC, Oesterle S, Hawkins JD. Effects of the communities that care prevention system on youth reports of protective factors. Prev Sci. 2015 Jul;16(5):652-62. doi: 10.1007/s11121-014-0524-9.
PubMed 25366931Kim BK, Oesterle S, Hawkins JD, Shapiro VB. Assessing Sustained Effects of Communities That Care on Youth Protective Factors. J Soc Social Work Res. 2015 Winter;6(4):565-589. doi: 10.1086/684163. Epub 2015 Oct 6.
PubMed 26951879Kuklinski MR, Fagan AA, Hawkins JD, Briney JS, Catalano RF. Benefit-Cost Analysis of a Randomized Evaluation of Communities That Care: Monetizing Intervention Effects on the Initiation of Delinquency and Substance Use Through Grade 12. J Exp Criminol. 2015 Jun 1;11(2):165-192. doi: 10.1007/s11292-014-9226-3.
PubMed 26213527Shapiro VB, Hawkins JD, Oesterle S. Building Local Infrastructure for Community Adoption of Science-Based Prevention: The Role of Coalition Functioning. Prev Sci. 2015 Nov;16(8):1136-46. doi: 10.1007/s11121-015-0562-y.
PubMed 26017632Shapiro VB, Oesterle S, Hawkins JD. Relating coalition capacity to the adoption of science-based prevention in communities: evidence from a randomized trial of Communities That Care. Am J Community Psychol. 2015 Mar;55(1-2):1-12. doi: 10.1007/s10464-014-9684-9.
PubMed 25323784Brown EC, Hawkins JD, Rhew IC, Shapiro VB, Abbott RD, Oesterle S, Arthur MW, Briney JS, Catalano RF. Prevention system mediation of communities that care effects on youth outcomes. Prev Sci. 2014 Oct;15(5):623-32. doi: 10.1007/s11121-013-0413-7.
PubMed 23828448Hawkins JD, Oesterle S, Brown EC, Abbott RD, Catalano RF. Youth problem behaviors 8 years after implementing the communities that care prevention system: a community-randomized trial. JAMA Pediatr. 2014 Feb;168(2):122-9. doi: 10.1001/jamapediatrics.2013.4009.
PubMed 24322060Oesterle S, Hawkins JD, Fagan AA, Abbott RD, Catalano RF. Variation in the sustained effects of the communities that care prevention system on adolescent smoking, delinquency, and violence. Prev Sci. 2014 Apr;15(2):138-145. doi: 10.1007/s11121-013-0365-y.
PubMed 23412948Kuklinski MR, Hawkins JD, Plotnick RD, Abbott RD, Reid CK. How has the economic downturn affected communities and implementation of science-based prevention in the randomized trial of communities that care? Am J Community Psychol. 2013 Jun;51(3-4):370-84. doi: 10.1007/s10464-012-9557-z.
PubMed 23054169Monahan KC, Hawkins JD, Abbott RD. The application of meta-analysis within a matched-pair randomized control trial: an illustration testing the effects of communities that care on delinquent behavior. Prev Sci. 2013 Feb;14(1):1-12. doi: 10.1007/s11121-012-0298-x.
PubMed 23111547
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay of Social, Normative, and Legal Marijuana Environments and Marijuana and ATOD Use From Late Childhood to Young Adulthood
- ClinicalTrials.gov ID
- NCT01088542
- Acronym / sponsor ID
- CYDS IV / STUDY00000692
- Conditions
- Substance Abuse, Juvenile Delinquency, Sexual Behavior, Criminal Behavior, Violence, Depression
- Keywords
- substance use, delinquency, risky sexual behavior, risk factors, protective factors, prevention, community coalitions, systems transformation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52,323 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Mar 2010 (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 Community Youth Development Study is an experimental test of the Communities That Care (CTC) prevention planning system. It has been designed to find out if communities that were trained to use the CTC system improved public health by reducing rates of adolescent drug use, delinquency, violence, and risky sexual behavior when compared to communities that did not use this approach. The primary purpose of the current continuation study is to investigate whether CTC has long-term effects on substance use, antisocial behavior, and violence, as well as secondary effects on educational attainment, mental health, and sexual risk behavior in young adults at ages 26 and 28. The continuation study also examines (a) how the interaction of social, normative, and legal marijuana contexts creates variation in the permissiveness of individuals' marijuana environments from late childhood to young adulthood and (b) whether, when, and for whom permissive marijuana environments increase marijuana and ATOD use and misuse from age 11 to 28 and interfere with the adoption of adult roles.
Detailed description
Preventing alcohol, tobacco, and other drug use; delinquency; violence; and health-risking sexual behavior among adolescents is a national priority. While advances in prevention science over the past two decades have produced a growing list of tested and effective programs and policies for preventing these behaviors, widespread dissemination and high-quality implementation of these effective programs and policies in communities has not been achieved. The development and testing of approaches for translating prevention research findings into effective community prevention service systems with long-term impact is important to achieving reductions in the prevalence of adolescent health and behavior problems that are sustained into adulthood.
The Community Youth Development Study (CYDS) is a community-randomized trial of the effects of Communities That Care (CTC) on community prevention systems and adolescent risk, protection, and behavioral health outcomes. The current continuation study is evaluating the long-term effects of CTC on a panel of 4,407 young adults at ages 21 and 23 who have been surveyed regularly since the trial started when they were in grade 5.
CTC is a prevention planning and capacity building system for improving behavioral health problems among youth community-wide. CTC guides communities to implement with fidelity and monitor the results of effective prevention programs that address community-specific elevated risk factors and depressed protective factors and reduce problem behavior. The CTC system is hypothesized first to produce improvements in key characteristics of community prevention service systems, which, in turn, reduce community levels of risk, increase protective factors, and lower rates of youth problem behaviors.
The CYDS communities were matched in pairs within state, on population size, racial and ethnic diversity, economic indicators, and crime rates. One community from each matched pair was assigned randomly by a coin toss to either the intervention or control condition. Starting in 2003, intervention communities received training, technical assistance, and materials and funding needed to install the CTC prevention system in years 2-5 (2004-2008), hire a community coordinator, and implement 2-5 tested preventive interventions. Selected interventions addressed local prevention priorities established by communities after reviewing local epidemiological data on youth risk factors, protective factors and problem behaviors. Control communities received no training or technical assistance from the study. Technical assistance and study-provided funding to intervention communities ended after 5 years.
The initial CYDS trial (2003-2008) evaluated the efficacy of CTC in reducing levels of risk, increasing levels of protection, and reducing levels of drug use and other problem behaviors in adolescents from Grades 5 through 9. It also tested the effects of CTC on prevention service system transformation (e.g., increases in a science-based approach to prevention, collaboration among prevention service organizations, support for prevention, community norms against drug use and delinquency, and use of the Social Development Strategy to guide interactions with youth) as reported by key community leaders and members of CTC coalitions.
The first continuation study (2009-2013) assessed the effects of installation and implementation of CTC when panel youth were in Grades 10 through Age 19. During this period, panel youth passed through high school, the developmental period of greatest risk for delinquent and violent behavior, and a period of greatly increasing substance use and problems related to substance use. The study evaluated the long-term effects of CTC on adolescent and young adult risk and problem behaviors, including primary outcomes of substance use and abuse, delinquency, crime, and violence. It also evaluated the sustainability of the CTC prevention system without the study-provided funding and support that were offered during the implementation of CTC in the 12 intervention communities during the initial efficacy trial.
The second continuation study (2013-2017) investigated the long-term effects of CTC on young adult substance use and misuse, crime, violence, and incarceration 11 and 13 years following CTC's initial installation. It also evaluated possible effects on a number of secondary outcomes salient in young adulthood, including HIV/AIDS sexual risk behavior, depression and suicidality, anxiety and other mental health disorders, and educational attainment. Panel youth were surveyed twice during the study, at ages 21 and 23.
The third continuation study (2018-2023) further investigates the long-term effects of CTC on the study's primary outcomes of substance use and misuse, crime, violence, and incarceration 16 and 18 years after CTC was installed in intervention communities. As in the prior continuation, it will also evaluate possible long-term effects on salient secondary outcomes, including HIV/AIDS sexual risk behavior, depression and suicidality, anxiety and other mental health disorders, and educational attainment. Another major aim of this study is to examine the normative and legal environment around marijuana use in the U.S., which is becoming more permissive, raising concern that it will increase youth and young adult marijuana and other drug use and associated negative consequences including addiction. Understanding how marijuana use norms and behaviors in multiple social contexts (e.g., peer, family, and community) interact with the legal marijuana context and impact drug use behavior from age 11 to 28 will assist in the identification of malleable targets for interventions and public health approaches to prevent the possible negative outcomes of increasing permissiveness towards marijuana use. Panel participants will be surveyed twice, at ages 26 and 28.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Communities in the no intervention arm received no intervention from the project and continued to implement prevention services as usual. |
| Communities That Care Intervention | Experimental | Behavioral: Communities That CareCommunities randomly assigned to the experimental condition received 5 years of training and technical assistance (from 2003 to 2008) to implement the Communities That Care (CTC) prevention system in their communities. They also received 5 years of funding to support a full-time community coordinator and 4 years of seed money to implement tested and effective prevention programs selected as a result of their CTC process. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Resident at baseline in one of the 24 participating communities
- Student in the Class of 2011 panel sample or in grades 6, 8, 10, or 12 during a survey year
- Community leader or prevention service provider in one of the participating communities
Key exclusion criteria (1 listed)
- Unable to read and comprehend consent materials and/or survey questions in either english or spanish
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 |
|---|---|---|
| Communities That CareThe Communities That Care (CTC) system provides communities training and ongoing technical assistance in a structured process for conducting prevention needs assessments using epidemiological data on levels of risk and protective factors for adolescent problem behaviors, selection of tested and effective preventive interventions shown to address community-prioritized factors, implementation of these interventions with fidelity, and evaluation of the community's progress toward its goals. The CTC system is designed to produce a plan for prevention services that is tailored to the needs of each community. CTC is installed in five phases through a manualized series of training events designed to build the capacity of communities to install and sustain the system over time. | Behavioural | Communities That Care Intervention |
Primary outcome
Targeted risk and protective factors, substance use, delinquency, violence
Time frame: Baseline through thirteen-year follow-up (age 23)
Surveys of the panel starting in 5th grade (2004) and continuing in grades 6-10, grade 12, and at ages 19, 21, and 23 are used to assess the impact of the intervention on risk and protective factors targeted by communities, substance use, delinquency, and violence. Cross-sectional surveys of all youth in grades 6, 8, 10, and 12 in all participating communities, conducted every 2 years from 2002 through 2012, are also used to assess the impact of the intervention on these primary outcomes.
CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation
Time frame: Baseline through eight-year follow-up (age 18)
Structured telephone interviews with key community leaders, CTC coalition members, and prevention services providers (Community Key Informant Survey, Coalition Board Interview, Community Resource Documentation Survey) conducted in 2001-02, 2004-05, 2007-08, 2009-10, and 2011-12 are used to assess intervention effects on CTC coalition functioning, prevention system transformation, and evidence-based prevention program implementation.
1 secondary outcome
Substance use disorder, depression and generalized anxiety disorder, sexual risk behavior
Time frame: Nine- through thirteen-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 29565666Oesterle S, Kuklinski MR, Hawkins JD, Skinner ML, Guttmannova K, Rhew IC. Long-Term Effects of the Communities That Care Trial on Substance Use, Antisocial Behavior, and Violence Through Age 21 Years. Am J Public Health. 2018 May;108(5):659-665. doi: 10.2105/AJPH.2018.304320. Epub 2018 Mar 22.
- Background: PubMed 29463119Rhew IC, Oesterle S, Coffman D, Hawkins JD. Effects of Exposure to the Communities That Care Prevention System on Youth Problem Behaviors in a Community-Randomized Trial: Employing an Inverse Probability Weighting Approach. Eval Health Prof. 2018 Jun;41(2):270-289. doi: 10.1177/0163278718759397. Epub 2018 Feb 20.
- Background: PubMed 26377418Oesterle S, Hawkins JD, Kuklinski MR, Fagan AA, Fleming C, Rhew IC, Brown EC, Abbott RD, Catalano RF. Effects of Communities That Care on Males' and Females' Drug Use and Delinquency 9 Years After Baseline in a Community-Randomized Trial. Am J Community Psychol. 2015 Dec;56(3-4):217-28. doi: 10.1007/s10464-015-9749-4.
- Results publication: PubMed 26462492Rhew IC, Hawkins JD, Murray DM, Fagan AA, Oesterle S, Abbott RD, Catalano RF. Evaluation of Community-Level Effects of Communities That Care on Adolescent Drug Use and Delinquency Using a Repeated Cross-Sectional Design. Prev Sci. 2016 Feb;17(2):177-87. doi: 10.1007/s11121-015-0613-4.
- Results publication: PubMed 27397946Gloppen KM, Brown EC, Wagenaar BH, Hawkins JD, Rhew IC, Oesterle S. Sustaining Adoption of Science-based Prevention Through Communities That Care. J Community Psychol. 2016 Jan;44(1):78-89. doi: 10.1002/jcop.21743. Epub 2015 Dec 18. No abstract available.
- Results publication: PubMed 25366931Kim BK, Gloppen KM, Rhew IC, Oesterle S, Hawkins JD. Effects of the communities that care prevention system on youth reports of protective factors. Prev Sci. 2015 Jul;16(5):652-62. doi: 10.1007/s11121-014-0524-9.
- Results publication: PubMed 26951879Kim BK, Oesterle S, Hawkins JD, Shapiro VB. Assessing Sustained Effects of Communities That Care on Youth Protective Factors. J Soc Social Work Res. 2015 Winter;6(4):565-589. doi: 10.1086/684163. Epub 2015 Oct 6.
- Results publication: PubMed 26213527Kuklinski MR, Fagan AA, Hawkins JD, Briney JS, Catalano RF. Benefit-Cost Analysis of a Randomized Evaluation of Communities That Care: Monetizing Intervention Effects on the Initiation of Delinquency and Substance Use Through Grade 12. J Exp Criminol. 2015 Jun 1;11(2):165-192. doi: 10.1007/s11292-014-9226-3.
- Results publication: PubMed 26017632Shapiro VB, Hawkins JD, Oesterle S. Building Local Infrastructure for Community Adoption of Science-Based Prevention: The Role of Coalition Functioning. Prev Sci. 2015 Nov;16(8):1136-46. doi: 10.1007/s11121-015-0562-y.
- Results publication: PubMed 25323784Shapiro VB, Oesterle S, Hawkins JD. Relating coalition capacity to the adoption of science-based prevention in communities: evidence from a randomized trial of Communities That Care. Am J Community Psychol. 2015 Mar;55(1-2):1-12. doi: 10.1007/s10464-014-9684-9.
- Results publication: PubMed 23828448Brown EC, Hawkins JD, Rhew IC, Shapiro VB, Abbott RD, Oesterle S, Arthur MW, Briney JS, Catalano RF. Prevention system mediation of communities that care effects on youth outcomes. Prev Sci. 2014 Oct;15(5):623-32. doi: 10.1007/s11121-013-0413-7.
- Results publication: PubMed 24322060Hawkins JD, Oesterle S, Brown EC, Abbott RD, Catalano RF. Youth problem behaviors 8 years after implementing the communities that care prevention system: a community-randomized trial. JAMA Pediatr. 2014 Feb;168(2):122-9. doi: 10.1001/jamapediatrics.2013.4009.
- Individual participant dataSharing planned: Yes. We support the goal of making datasets available to researchers in a timely manner to expedite translation of research results into knowledge, products, and procedures to improve human health. With these goals in mind, we have entered into data-sharing collaborations many times with outside researchers. To ensure that the use of these data stay within the legal and ethical constraints of the consent agreement under which they were collected, we have developed a Fair Use Agreement, available upon request, that is signed by the Principal Investigator, Dr. Kuklinski, and by the collaborating researcher when agreement has been reached to share study data. As part of the Fair Use Agreement, we ask researchers to abide by the same Data and Safety Monitoring Plan (DSMP) that we adhere to. We will continue to share data with other researchers who meet the terms of our Fair Use Agreement (and DSMP) and share our strong commitment to protection of the rights and privacy of study participants.
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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.
Margaret Kuklinski, Ph.D. principal investigator
University of Washington
Sabrina Oesterle, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communities That Care in people with Substance Abuse and Juvenile Delinquency, run by University of Washington 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Targeted risk and protective factors, substance use, delinquency, violence (time frame: Baseline through thirteen-year follow-up (age 23)). The study lists 2 primary outcomes in all. 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 NCT01088542, which also lists 40 linked publications.
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 7 Feb 2025.