The Community Youth Development Study: A Test of Communities That Care (CYDS III)
|First Received Date ICMJE||March 15, 2010|
|Last Updated Date||January 17, 2017|
|Start Date ICMJE||October 2003|
|Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
||Youth Substance Use, Delinquency, and Risky Sexual Behavior [ Time Frame: Baseline through eight-year follow-up ]
Self-report longitudinal surveys of the Class of 2011 conducted annually starting in 5th grade (2004) and continuing through 2012 (one year post-HS), and cross-sectional anonymous surveys of 6th, 8th, 10th, and 12th grade students in all participating communities conducted every 2 years from 2002 through 2012 will be used to assess the impact of the intervention on students' behaviors.
|Change History||Complete list of historical versions of study NCT01088542 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Substance use disorder, depression and generalized anxiety disorder, sexual risk behavior [ Time Frame: Nine- through thirteen-year follow-up ]
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).
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Community Youth Development Study: A Test of Communities That Care|
|Official Title ICMJE||Long-term Effects of Communities That Care on Young Adults From Small Towns|
|Brief 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 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 21 and 23.|
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 current continuation study (2013-2017) is investigating 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. Also being evaluated are 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 have been surveyed twice during the study, at ages 21 and 23.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: Communities That Care
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2016|
|Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||10 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01088542|
|Other Study ID Numbers ICMJE||36664-J, R01DA015183|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Yes|
|IPD Description||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. Oesterle, 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.|
|Responsible Party||Sabrina Oesterle, University of Washington|
|Study Sponsor ICMJE||University of Washington|
|Collaborators ICMJE||National Institute on Drug Abuse (NIDA)|
|Information Provided By||University of Washington|
|Verification Date||January 2017|
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