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Conceptual
Framework and Measures
The long-term goal
of the Fast Track project is to test the effectiveness of a developmentally
based sequence of interventions designed to prevent antisocial and related
behavior problems. During the year 2003, all three cohorts at each of
the four research sites will complete the full intervention program
scheduled through the tenth grade. Annual assessment of each cohort
includes multiple measures of functioning to assess reduction of negative
outcomes, as well as improvement in the protective factors targeted
in the intervention model. A variety of strategies is used to assess
behavioral development, including parent and teacher reports, direct
behavioral observation, peer ratings, child and youth self-reports,
test performance, and archival school, police, and court records. The
impact of the program on behavior problems involving conduct disorder,
oppositional defiant disorder, delinquent behavior, and other major
adjustment problems is evaluated using standard psychiatric interviews
with high-risk youth and their parents at the end of grades 3, 5, 6,
9, and 12. Measures of other problem behaviors, program implementation
measures, measures of predictors of change, and family and school context,
are assessed for both the high-risk study sample and the normative sample
at the same cohort-specific time points. The years that measures were
administered to each cohort are listed in the "measures and administration
history" section of this website.
As far as possible,
the same measures have been maintained over time in order to track the
developmental course of behavior. However, some measures have been discontinued
and others added over time, as appropriate to the developmental stages
of the study sample. The measures are listed alphabetically and described
in detail in the "Measures and Administration
History" section of this website; in the discussion and tables
below, the measures are listed categorically, in terms of the conceptual
categories identified in the project's research design. The goals and
research strategies have evolved in accordance with changing nature
of behavior outcomes, age-appropriate intervention strategies, and the
coordination of measures in the adolescent phase with other longitudinal
studies and with the Fast Track benefit-cost analysis. Therefore, the
measures are described separately for the elementary-school age and
adolescent phases of the project in Tables 1 and 2 below.
Table 1. Measures used during the elementary-school phase
Of the Fast Track Project
I. Child behavior at home and in the neighborhood, and parent-child relationships
A. Parent-child interactions, parental acceptance/rejection of child
1. Parent report: Conflict Tactics Scale, Parent Daily Report, Values Questionnaire,
Family Expressiveness Questionnaire, Parent Questionnaire, Life Changes Interview
2. Direct observation: Parent-child Interaction Task (PCIT), Behavioral Coding System
(BCS) Interpersonal Process Code (IPC), Interaction Rating Scales (IRS), Coder
Impressions Inventory (CII), Post-Visit Inventory
3. Child report: Child Report of Parental Monitoring, People in my Life
B. Child Behavior
1. Parent report: Child Behavior Checklist (CBCL), Parent Daily Report, ADHD Rating
Scale-P, Life Changes Interview, Parents' Checklist
2. Direct observation: PCIT-BCS, IPC, IRS, CII, Post-Visit Inventory
C. Family Ecology
1. Parent report: Conflict Tactics Scale, Relationship Adjustment Scale, Inventory
of Parent Experiences, Feelings Scale, Family Information Form, Life Changes Interview,
Being a Parent, Parent Opinion Questinnaire, Neighborhood Questionnaire, Financial Stress
Questionnaire
2. Direct observation: Post-Visit Inventory
II. Child behavior at school and classroom support for appropriate behavior
A. Teacher behavior: Classroom Atmosphere Ratings, MOOSES Observation System
B. Child behavior:
1. Teacher ratings: CBCL-TRF, Social Health Profile (SHP), Social Competence Scale-T,
Teacher Checklist, Teacher Practices, ADHD Rating Scale-T
2. Direct observation: MOOSES Observation System, Minnesota Affect Rating Form,
Classroom Atmosphere Rating, CBCL Direct Observation Form
3. Peer ratings: Sociometric Interview
III. Social Information Processing and Affect Regulation
A. Child report: Home Interview, Emotion Recognition Questionnaire, Social Problem-Solving
Measure, About Me, Things that Happen to Me, Feelings Scale, Seattle Personality
Questionnaire, Interview on Emotional Experience, What Do You Think?
B. Parent report: Social Competence Scale-P
C. Teacher report: Social Competence Scale-T
D. Direct observation: Minnesota Affect Rating Form
IV. Child inter-personal relationships: peer directed aggression and peer relations
A. Parent report: CBCL, Social Competence Scale-P
B. Teacher ratings: TRF, SHP, Social Competence Scale-T
C. Peer ratings: Sociometric Interview
D. Direct observation: Minnesota Affect Rating, MOOSES, Classroom Atmosphere Rating
V. Academic Achievement, ability, attitudes and behavior toward school
A. Standardized tests: Woodcock-Johnson reading and math, school administered
achievement tests (e.g., CAT), WISC-III
B. School records: grades, grade retention, special class referrals, absenteeism, School
Records Form
C. Teacher ratings: CBCL-TRF
D. Child report: Seattle Personality Questionnaire
VI. Family-School Relations and Parental Involvement in School
A. Parent report: Parent and Teacher Involvement Questionnaire-P, Life Changes Interview
B. Teacher ratings: Parent and Teacher Involvement Measure-T
VII. Conduct disorder, oppositional/defiant disorder, and other behavior disorders
A. Child report: Diagnostic Interview Schedule for Children (DISC)
B. Parent report: DISC, CBCL, ADHD-P
C. Teacher report: ADHD-T
Table 2: Measures used during the adolescent phase
Of the Fast Track Project
I. Problem behaviors targeted by the Fast Track intervention
A. Antisocial behavior, delinquency, substance use, sexual activity, school dropout
1. Self report: DISC, Self-Report on Delinquency, Tobacco, Alcohol and Drugs,
Romantic Relationships Questionnaire, Pregnancy, SA-C School Adjustment, Suicide,
Police Contact
2. Parent report: DISC/CBCL, Parent Daily Report, Parent Checklist, Parental Report
on Child's Delinquency
3. Teacher report: Teacher Report Form/externalizing, TRCP, Social Health Profile
4. Archival: Court and School Records, School Records Form (SRF)
B. Psychiatric disorders and mental health services utilization
5. Self-report: DISC/Youth Self-Report, Mental Health Services Utilization (SACA)
6. Parent report: Psychopathy Screening Device, Life Changes, DISC, Mental Health
Services Utilization (SACA), Vanderbilt Mental Health Services Efficacy
Questionnaire
II. Protective factors targeted by the Fast Track intervention
A. Peer Relations: Involvement in prosocial acts, peer affiliations/deviance, peer delinquency,
gang involvement, peer victimization
1. Self-report: Religiosity, Close Friends, Adolescent Stories, Guns and Gangs, Police
Contact, Things that You Have Done, Things that Your Friends have Done
2. Parent report: Parental Report on Child's Delinquency, Parent Report on Child's Close
Friends
3. Teacher report: Social Health Profile, Social Competence
B. Parent and other adult monitoring/communication/involvement
1. Self-report: Parent/Child Communication/Involvement (PCCS-C), About my Parent,
Supervision, People in my Life, Problem Solving Discussion Rating
2. Parent report: Parent/Child Communication/Involvement (PCCS-P), Parent Questionnaire,
Parent Issues Checklist, Parenting Practices Inventory, Parent-Teacher Involvement,
Parenting-Primary Caregiver, Conflict Tactics Scale, Supervision, Problem Solving
Discussion Rating
3. Direct observation: Observer Impressions on Parent-Child Interaction Task (PCIT)
C. Academic achievement and orientation
1. Self-report: SA-C School Adjustment, Self-Efficacy in School
2. Teacher report: Teacher Report Form, Teacher Rating of Student Adjustment
3. Parent report: SA-P School Adjustment
4. Archival: School Records Form
D. Social Cognition and Identity Development (Norms, Attitudes, Values, and Social Information
Processing)
1. Self-report: Adolescent Stories, About Myself, Expectations/Aspirations, Possible
Selves, Attitudes About Behavior, Problem Solving Discussion Ratings, Relationship
Conflict Tactics Scale, Ethnic Identity Scales, Teenager Experience of Racial
Socialization, Handling Race Experiences, Race Coping Measure, Suicide
2. Teacher report: Social Competence, Social Health Profile
III. Moderators of Outcomes
E. Family/Neighborhood Ecology
1. Self-report: Religiosity, My Exposure to Violence, Feelings about Neighborhood, Fear
of Crime, Neighborhood Questionnaire; Guns and Gangs
2. Parent report: Questions on Parent Health, Financial Stress Questionnaire, Life Changes
Interview, Family Information Form, Relationship Adjustment Scale, Conflict Tactics
Scale
F. Youth Factors: physical development, work/employment, involvement in other activities
self-reported): Recent Growth, NLS-Y Youth Employment, Youth Finances, Training other than
Schooling, Questions Regarding Driving, Extracurricular Activities
Sample
Description
The study sample
of kindergarten children at high risk for conduct disorder was identified
using a multi-stage screening procedure. First, high-risk schools were
identified in four different areas of the United States, using crime
records, poverty statistics, and high school dropout rates. The schools
were then divided into two sets matched on size, ethnic composition,
achievement scores, and percentage of free lunch recipients; half of
the schools were assigned, randomly, to receive intervention services
and the other half were considered control schools. In the spring of
1991, 1992, and 1993, teachers rated the behavior problems of each of
the kindergarten children in the 55 participating elementary schools,
using a screening instrument that measures aggressive and oppositional
behaviors. The scores from the teacher ratings were then combined with
parent ratings of child behavior at home. Children who scored in the
top ten percent of the combined screen were considered to be the high-risk
target group, and were invited to participate in the Fast Track longitudinal
study. Of the total number of children screened, 9.3 percent were selected
to be part of the high-risk sample. The 445 children from this group
who attended an intervention school were placed in the intervention
group, and the 447 attending non-intervention schools were placed in
the control group for the study. Contrasts between the intervention
and control groups on demographic and behavioral variables indicate
that there are no significant differences between the groups prior to
the intervention program.
A representative
sample of 387 children was selected from the control schools to serve
as a non-high risk normative sample. Within each of the four sites,
children were stratified to represent the population according to sex,
race, and decile score on the teacher screen measure, and then chosen
randomly to participate in the study. This normative sample was recruited
only in the first cohort of the study.
As expected, pre-intervention
contrasts between the high risk and normative samples indicated that
the high risk group was at considerable disadvantage. Among the high
risk children, 58 percent came from single parent households (as compared
with 35 percent of the normative group), 35 percent of the high risk
group were of the lowest socioeconomic status, as compared with 23 percent
of the normative group, and 51 percent of those at high risk were African
American, as compared with 43 percent of the normative group.
Attrition from
the sample has been low, as compared with most longitudinal studies.
By year 11, the rate of subjects not providing any data (during the
previous 12 month period) varied between 15 to 20 percent across intervention
and high-risk status groups. As is natural, the rate of attrition has
increased over time, from a low of 5 percent after the first year of
the study. The attrition rate has not been found to vary by gender or
cohort; the latest analyses yield marginally significant variations
across the control, intervention, and normative groups, as well as across
study sites. The Fast Track Data Center keeps rigorous and detailed
accounts of missing data, and recommends evaluating the possible impact
of attrition on analyses for grade 4 and beyond.
Using
the Fast Track Data Catalog
The Measures
and Administration History section of this website contains a searchable
catalog of the datasets collected and compiled as part of the Fast Track
Project. The measures are listed alphabetically, and arrayed according
to the years that each measure was administered to each cohort. The
title of each measure links directly to an abstract describing the instrument
in terms of its source, variable definitions and response values, scaling
procedures, and the characteristics of the resulting scales. The abstract
also summarizes the Fast Track Data Center's recommendations for use
of these scales in analyzing datasets derived from the measure.
The measure's abstract
page provides a link to the corresponding technical report, which contains
a description of the study sample administered this instrument during
each year of the study. The technical report also provides a summary
analysis comparing the high-risk control group with the normative (low-risk)
group. The analysis includes evaluation of differences between groups,
item and scale means and standard deviations, and item and scale correlations.
Catalog information
for instruments developed by the Fast Track Project includes either
a screen image of the measure as administered by laptop computer, or
a listing of the contents of the scored dataset. Source information
is given for measures developed outside of the project and adapted for
use within Fast Track.
The data catalog's
search engine queries the entire website for the terms entered, returning
a list of documents scored on the basis of relevance to the query words
or phrases. Keywords are included in the abstract for each measure,
in order to facilitate user searches for particular topics and sub-groups.
A search also will yield links to relevant publications and their abstracts,
as listed on the Publications page of
the Fast Track Project website.
Citing
Information from the Fast Track Project
Citations of online
information from this website should include the following:
"Section Title."
Fast Track Data Center. "Date." datacenter.htm
The bibliographic
citation for the data collection is as follows:
Conduct Problems
Prevention Research Group and the Fast Track Project. Fast Track Study
Cumulative Data Files, 1992-2003 [Computer Files]. Durham, North Carolina:
Fast Track Data Center, Duke University.
Furthermore, all
written reports and publications using Fast Track data should contain
the following acknowledgement:
This research is based on data from the study entitled ["Fast Track,"
or "Multi-Site Prevention of Adolescent Problem Behaviors,"
or "Multisite Prevention of Conduct Disorder"], supported
by National Institute of Mental Health (NIMH) Grants R18 MH48043,
R18 MH50951, R18 MH50952, R18 MH50953, and R01 MH62988. The Center
for Substance Abuse Prevention and the National Institute on
Drug Abuse also have provided support through a memorandum of agreement
with the NIMH. Department of Education Grant S184U30002 and NIMH
Grants K05MH00797 and K05MH01027 also supported the study. The study
was designed by the Conduct Problems Prevention Research Group,
which currently includes, in alphabetical order, Karen L. Bierman, Pennsylvania
State University; John D. Coie, Duke University; Kenneth A. Dodge, Duke
University; Mark T. Greenberg, Pennsylvania State University; John E.
Lochman, University of Alabama; Robert J. McMahon, University of Washington;
and Ellen E. Pinderhughes, Vanderbilt University.
Requesting
and Using Fast Track Data (Restricted Use of Data)
Data Availability
The data catalog,
found in the "Measures
and Administration History" section of this website, provides
a comprehensive listing of the datasets and documentation that are being
compiled by the Fast Track project. This catalog is updated continuously
to reflect additions to the data collection [Using
the Fast Track Data Catalog].
Data collected by
the Fast Track project will be released for use by the scientific community,
for research purposes only, through the restricted-use mechanism described
below. The data are being released gradually, by year of the study,
with future releases announced on this website. As of May 2007, data
for all three respondent cohorts are available for years 1 through 9,
which correspond to grades K through 8.
The following chart
provides the calendar years and grades corresponding to years 1 through
9 of the project, for each respondent cohort:
2001 ('00 - '01)
Year 9 Cohort 3 Grade 8
2000 ('99 - '00)
Year 9 Cohort 2 Grade 8
Year 8 Cohort 3 Grade 7
1999 ('98 - '99)
Year 9 Cohort 1 Grade 8
Year 8 Cohort 2 Grade 7
Year 7 Cohort 3 Grade 6
1998 ('97 - '98)
Year 8 Cohort 1 Grade 7
Year 7 Cohort 2 Grade 6
Year 6 Cohort 3 Grade 5
1997 ('96 - '97)
Year 7 Cohort 1 Grade 6
Year 6 Cohort 2 Grade 5
Year 5 Cohort 3 Grade 4
1996 ('95 - '96)
Year 6 Cohort 1 Grade 5
Year 5 Cohort 2 Grade 4
Year 4 Cohort 3 Grade 3
1995 ('94 - '95)
Year 5 Cohort 1 Grade 4
Year 4 Cohort 2 Grade 3
Year 3 Cohort 3 Grade 2
1994 ('93 - '94)
Year 4 Cohort 1 Grade 3
Year 3 Cohort 2 Grade 2
Year 2 Cohort 3 Grade 1
1993 ('92 - '93)
Year 3 Cohort 1 Grade 2
Year 2 Cohort 2 Grade 1
Year 1 Cohort 3 Grade K
1992 ('91 - '92)
Year 2 Cohort 1 Grade 1
Year 1 Cohort 2 Grade K
1991 ('90 - '91)
Year 1 Cohort 1 Grade K
Access to Fast
Track Data
The Fast Track Project
is committed to a policy of allowing the research community access to
data, under conditions that strictly protect the rights and privacy
of Fast Track participants. The research design that has guided Fast
Track data collection over the entire study period requires a restricted-use
mechanism for sharing the data with the research community. As noted,
the restricted-use data policy currently applies to data from years
1 through 9 of the study, with additional data releases scheduled through
2008.
The rationale for
restrictions on data use is based on the level of sensitivity of the
data, where "sensitive data" are defined as any data from
a research project that may compromise the anonymity or privacy of respondents.
During the course of the study, the project staff has followed strict
guidelines to maintain the confidentiality of the data as it is processed,
and will take all appropriate steps to remove direct and indirect identifying
information from shared data files. However, the sensitive nature of
the data requires that we systematically safeguard the privacy and anonymity
of respondents by establishing a contractual agreement with investigators
and institutions requesting the data. The specific contractual conditions
are set forth in the Agreement for the Use of Data
from the Fast Track Project. Some of these conditions are described
briefly in this section.
Eligibility of Investigators
and Receiving Institutions
In order to be
considered eligible to receive Fast Track data, an investigator must
have a Ph.D. or other terminal degree, and hold a faculty appointment
or other research position at the receiving institution. Graduate students
who wish to use Fast Track data for dissertation research must apply
through their faculty advisors.
Eligible receiving
institutions include not-for-profit research organizations, government
agencies, and institutions of higher education. Receiving institutions
must have established protocols for reviewing research using sensitive
data, through an Institutional Review Board or equivalent body.
Requirements of
Investigators
As part of the
application procedure, the investigator must provide the Fast Track
Data Center with a written research proposal that describes research
questions, methodology, the measures/years/cohorts of data to be used,
and publication plans. A Sensitive Data Security Plan also is required,
outlining the measures that will be taken to ensure that no unauthorized
persons will have access to Fast Track data, and describing the computing
environment in which the data will be managed, stored, and analyzed.
Prior to release of Fast Track data, both the research proposal and
the data security plan must be approved by the Fast Track review committee
and by the receiving institution's Institutional Review Board.
To cover the expenses
of processing requests, producing and shipping data files and documentation,
and administering data use agreements, the Fast Track Data Center requests
payment of a non-refundable fee in the amount of $822 per day. Further
consultation with Data Center staff is available at this daily rate.
Deductive Disclosure
Risk
In order to further
safeguard the privacy and anonymity of respondents, all plans for use
of Fast Track data must address the risk of deductive disclosure-the
discerning of a respondent's identity through knowledge of a combination
of characteristics of that individual. The Data Use Agreement specifies
the following precautions that are required of researchers in any release
of statistics derived from Fast Track data:
- In a table, no single cell may contain all cases in any row or column.
- In no case should
the total figure for the row or column of a cross-tabulation be fewer
than three.
- In no case should
a quantity figure be based on fewer than three cases.
- In no case should
a quantity figure be published if one case contributes more that fifty
percent of the amount.
- Data should never
permit disclosure, either through calculation from a combination of
tables released, or when used in combination with other known data.
Data requests will
be reviewed carefully for potential disclosure issues through indirect
identifiers; for some combinations of data, it will be necessary to
apply statistical disclosure limitation techniques prior to data release.
For example, a cross-tabulation of respondent's race with study site
yields a quantity figure of 2 in one of the cells, with 99 percent of
cases in a single cell. Thus, for one of the study sites, individual-level
race categories will not be released. Across all study sites, the small
numbers of Asian and Native American respondents (three or fewer per
cohort) require that we collapse these categories of the race variable.
Site-specific cross-tabulations of gender by some disability categories
yield cells with 0, 1, or 2 cases; thus, information at this level of
detail will not be released. These and other potential disclosure limitations
will be discussed with the researcher and incorporated to the research
plan.
For further information
on requesting Fast Track data, please review the Agreement
for the Use of Data from the Fast Track Project and contact
the Fast Track Data Center: muschkin@duke.edu.
Funding
for the Fast Track Project
The Fast Track Project
gratefully acknowledges the financial support that has made this study
possible. Fast Track is supported by the National Institute of Mental
Health (NIMH) through Grants R18 MH48043, R18 MH50951, R18 MH50952,
R18 MH50953, and R01 MH62988. The Center for Substance Abuse Prevention
and the National Institute on Drug Abuse also have provided support
through a memorandum of agreement with the NIMH. Department of Education
Grant S184U30002 and NIMH Grants K05MH00797 and K05MH01027 also supported
the study.
The Fast Track Project
was designed by the Conduct Problems Prevention Research Group,
which has grown to include, in alphabetical order, Karen L. Bierman,
Pennsylvania State University; John D. Coie, Duke University; Kenneth
A. Dodge, Duke University; E. M. Foster (no longer with this project);
Mark T. Greenberg, Pennsylvania State University; John E. Lochman, University
of Alabama; Robert J. McMahon, University of Washington; and Ellen E.
Pinderhughes, Vanderbilt University.
Agreement for the Use of Data from the Fast Track
Project
I. Requirement
of Investigators and Receiving Institutions
Fast Track data
are released only for research use. Therefore, investigators must meet
the following criteria in order to be considered eligible to receive
Fast Track data:
-
have a PhD or
other terminal degree, and
-
hold a faculty
appointment or other research position at the receiving institution.
Receiving institutions
must meet the following criteria:
-
be an institution
of higher education, a research organization (non-profit), or a government
agency,
-
have a demonstrated
record of using sensitive data according to commonly-accepted
standards of research ethics,
-
and have established
protocols for an Institutional Review Board/Human Subjects Review
Committee or equivalent body to review research proposals using sensitive
data.
II. Research Proposal
Applicants for Fast
Track restricted data must provide to the Fast Track Data Center a written
description of the research project, including an abstract, research
questions, primary methodology, categories of variables to be used,
the types of data from other sources that may be merged with this restricted
data file, and plans for use of the results of the research, including
plans for publication. The research plan should specify the time frame
for analysis of the data.
III. Sensitive
Data Security Plan
Potential investigators
should submit a Sensitive Data Security Plan to the Fast Track Data
Center, outlining the measures that will be taken to ensure that no
persons, other than those authorized by the signed agreement, can have
access to the contents of the Fast Track data sets. This data protection
plan applies to the data files supplied by the Fast Track Data Center,
as well as any copies made by the research team, and any new data derived
from the restricted data. "Derived data" include subsets of
cases or variables, as well as numerical or other transformations of
variables from the original data.
The plan also should include a discussion of the computing environment
in which the data will be managed, analyzed, stored, and transmitted
among research team members. The investigators must address in detail
the security measures that will be implemented for protection of these
restricted data. Specific guidelines for preparing the Sensitive Data
Security Plan are outlined in Attachment 1.
IV. Review Board
Approval
Fast Track requires
that the investigator submit a copy of the document, signed by the receiving
institution's Institutional Review Board, approving the research project
and acknowledging the risks of deductive disclosure that require special
procedures for handling Fast Track data. The IRB also must approve the
procedures for the secure use and storage of the data as agreed in the
Sensitive Data Security Plan. Human Subjects review for Fast Track data
must be in accordance with procedures used for live human subjects;
the investigator may not request exemption from review. Fast Track will
release data only for projects that have received approval through expedited
or full board review of both the research proposal and the Sensitive
Data Security Plan.
V. Data Use Agreement
Obligations of
the Investigator, Research Staff, and Receiving Institution
The data provided
under this agreement shall be held by the investigator, research staff,
and receiving institution in strictest confidence and can only be disclosed
in compliance with the terms of the signed agreement. For use of data
files from the Fast Track Project, the investigator, research staff,
and receiving institution agree:
-
That the data
will be used solely for statistical analyses and that no attempt will
be made to identify specific individuals, families, households, schools,
or institutions, nor will any listing of data at the individual, family,
or school level be published or otherwise distributed.
-
That, if the identity
of any person, family, household, school, or institution should be
discovered inadvertently, then (1) no use will be made of this information,
nor will it be shared with anyone else; (2) one of the Principal Investigators
of the Fast Track project will be notified immediately of the incident;
(3) the identifying information will be safeguarded or destroyed as
requested by the Fast Track project.
-
To avoid inadvertent
disclosure of persons, families, households, or schools by taking
the
following precautions in the release of statistics derived from the
data set:
- In no table
should a single cell contain all cases in any row or column.
- In no case
should the total figure for row or column of a cross-tabulation
be fewer than three.
- In no case
should a quantity figure be based upon fewer than three cases.
- In no case
should a quantity figure be published if one case contributes more
than fifty percent of the amount.
- In no case
should data on an identifiable case, nor any of the kinds of data
listed above, be derivable through calculation from the combination
of tables released.
- Data released
should never permit disclosure when used in combination with other
known data.
-
That only the
persons identified in the data agreement as investigator or research
staff will have access to the contents of the data files, including
derived data files.
-
To comply fully
with the approved Sensitive Data Security Plan
-
To supply Fast
Track with Confidentiality Pledges (Attachment 2), with original signatures,
for the investigator and all research staff identified in the Supplemental
Agreement with Research Staff (Attachment 3).
-
To respond promptly
and in writing to inquiries from the Fast Track Data Center regarding
compliance with this agreement or the expected date of completion
of the research.
-
To include in
all written reports or other publication, the following statement:
This research
is based on data from the study entitled ["Fast Track,"
or "Multi-Site Prevention of Adolescent Problem Behaviors,"
or "Multisite Prevention of Conduct Disorder"], supported
by National Institute of Mental Health (NIMH) Grants R18 MH48043,
R18 MH50951, RH18 MH50952, and R18 MH50953. The Center for Substance
Abuse Prevention and the National Institute on Drug Abuse
also have provided support through a memorandum of agreement with
the NIMH. Department of Education Grant S184U30002 and NIMH
Grants K05MH00797 and K05MH01027 also supported the study. The study
was designed by the Conduct Problems Prevention Research Group,
whose members include, in alphabetical order: Karen L. Bierman, Pennsylvania
State University; John D. Coie, Duke University; Kenneth A. Dodge,
Duke University; E. M. Foster (no longer with this project); Mark
T. Greenberg, Pennsylvania State University; John E. Lochman, University
of Alabama; Robert J. McMahon, University of Washington; and Ellen
E. Pinderhughes, Vanderbilt University.
To comply with
copyright restrictions in the use of documentation from the Fast Track
Data Archive. This documentation provides the information needed by
researchers to understand the purpose of the measure used to create
the dataset, the meaning of individual items and derived variables,
response codes, and any other basic descriptors. While not a facsimile
of the instrument used to collect the data, the documentation provides
a considerable amount of information regarding its content. This information
must not be reproduced or distributed; it is to be used solely for
purposes specifically relevant to the interpretation of Fast Track
data requested by the investigator for the approved project.
-
To destroy all
electronic and paper files at a date specified within the data use
agreement. This date will likely depend, in part, upon the complexity
of the project, the professional societies and journals to whom the
data will be reported, and the data retention policy of the institution
with which the investigator is associated.
- To provide annual
reports to the Fast Track Data Center, which include:
1. copy of the
annual IRB approval for the project
2. a listing of public presentations at professional meetings using
results based on the data,
3. copies of papers accepted for publication using these data, with
complete citations.
- In the event
that the investigator changes institutional affiliation during the period
covered by this contract, the investigator will take the following actions:
1. Inform the
Fast Track Data Center prior to relocation
2. Resubmit a data security plan and obtain signed IRB approval from
the new institution.
3. Provide assurance
that all data files are removed from the original site.
-
Research subjects
who participated in the Fast Track project are protected by a certificate
of confidentiality issued by the Department of Health and Human Services
in accordance with section 301(d) of the Public Health Service Act
42 U.S.C. 241(d). Under the terms of this agreement, the Confidentiality
Certificate applies to the receiving institution, investigator, and
research staff as "contractors or cooperating agencies;"
as such, they are "authorized to protect the privacy of the individuals
who are the subjects of the Fast Track project by withholding their
identifying characteristics from all persons nor connected with the
conduct of the research." "Identifying characteristics"
are considered to include all those data defined as sensitive under
the terms of this agreement.
-
That the receiving
institution will treat allegations, by Fast Track or other parties,
of violations of the confidentiality provisions in this agreement
as allegations of violations of its policies and procedures on scientific
integrity and misconduct. If the allegations are confirmed, the receiving
institution will treat the violations as it would violations of the
explicit terms of its policies on scientific integrity and misconduct.
Obligations of
the Fast Track Project
-
The Fast Track
project will promptly respond to inquiries regarding use of the restricted
data, and encourage interested persons to submit a preliminary description
of the research plan. Applications for data use, requiring submission
of a data use agreement under the provisions outlined above, will
be reviewed and processed within a month of receipt of the completed
application.
-
The data files
requested by the investigator will be provided within one month of
the execution of the data use agreement. The data will be sent on
CD ROM by express mail, for a fee to cover these and other administrative
costs. Electronic documentation of the content of the data files will
be sent within the same period.
- As long as the
Fast Track project is supported by a federal research grant, the Data
Center will provide limited telephone and email consultation to the
investigator and/or research staff as to the origins, structure, and
general content of the data files sent. Further consultation with Data
Center staff as to techniques for data management or analysis will be
available for an additional fee.
VI. Incorporation
by Reference
The parties agree that
the following documents are incorporated into this agreement by reference:
-
A copy of the
IRB approval of the research project, taking into special consideration
deductive disclosure risks, at the expedited or full level of review.
-
The
Sensitive Data Security Plan proposed by the investigator and approved
by the Fast Track Project staff.
VII. Attachments
-
Guidelines for
Sensitive Data Security Plan for the use of data from the Fast Track
Project
-
Sample Security
Pledge for the Use of Data from the Fast Track Project
-
Supplemental Agreement
with Research Staff for the Use of Fast Track Data
-
Description of
Deductive Disclosure Risk from the Fast Track Project.
Attachment
1
Guidelines for Sensitive Data Security Plan
For the use of Fast Track Data
The fundamental goal of the protections outlined in the Data Security
Plan is to prevent persons who are not signatories to the Data Use Agreement
or the Supplemental Agreement with Research Staff from gaining access
to the data. When these agreements are executed, all members of the research
team are obligated to follow all aspects of the Data Security Plan.
General Information
Required for all Data Requests
-
The names, titles,
and responsibilities of all the investigators(s) and research staff
(students, research assistants, and programmers) who will have access
to the data. Any changes in personnel would require that this information
be updated.
-
Security pledges
signed by all project personnel should be included with the Application.
Any new personnel added during the research period would require that
an amended Attachment 3 be sent to the Fast Track Data Center. A sample
security pledge is attached (Attachment 2).
-
A detailed description
of the computer system where the data will be stored and analyzed.
This description should include the following:
- All locations
where copies of the data and paper files will be kept.
- The computing
platform, number of computers on which data will be stored or analyzed,
whether personal computers will be stand-alone or networked, the
physical environment in which computers are kept, and who has physical
access to the equipment.
- The devices
on which data will be stored, how the computer system handles backups,
and how long system backup copies of the data are kept.
- Information
on the security of the backup copies of the data made by the research
team, including the original data sent by Fast Track and temporary
analysis files. Temporary files must be deleted at the end of each
year and re-created, if necessary, to complete the research.
- The security
system that would prevent unauthorized access to the data, and whether
this system is used by other projects.
- The time frame
for analysis of the data, including the end date of the project. This
date should not exceed three years from the execution of the data use
agreement. Should the research project require additional time, a request
for continuation should be submitted three month prior to the specified
end date. Unless prior arrangements are made with the Fast Track Data
Center, all electronic and paper data must be destroyed on the end date.
Specific Guidelines
-
The use of stand-alone
personal computers with data stored on the hard drive is strongly
discouraged. It is preferred that the data be stored on a secure network.
If, however, a network is not available, then the personal computer
must meet the current Fast Track policy. That is, the computer must
be located in a locked office, with access restricted to project personnel
only. Further, the computer must be secured to a stationary object
(such as a desk) using an Anchor Padã (or similar device) and
the case itself must be secured so that the hard drive could not be
removed. Use of the computer is restricted to project personnel only,
with password-protected access to the computer. Thus, the computer
must use Windows NT 4.0, Windows 2000, or Windows XP as the operating
system. The use of personal firewalls is strongly recommended.
-
For sites using
local area networks, security of the file server must follow Fast
Track policies. That is, the file server needs to be located in a
room with access restricted to network administrators. The unit itself
must be secured to a stationary object (such as a desk) using an Anchor
Padã (or similar device) and the case itself must be secured
so that the hard drive(s) could not be removed (this includes securing
access to "hot-swappable" drives). It is strongly recommended
that the file server use Novell as the operating system because of
serious security concerns with Microsoft networks (if a Microsoft
network is used, then constant monitoring and application of available
security patches must occur). All authorized users must have a user
name and a "strong" password to access the file server (strong
passwords cannot use any word found in a standard dictionary, names
of relatives, and must be made up of upper and lower case letters
and numbers). If the data will be stored on a mainframe computer,
then it is strongly recommended that the researcher contact the computer
security officer to ensure that the data remain secure.
-
No data or analysis
output derived from the data can be transmitted via e-mail, e-mail
attachments, or FTP. If the data are stored on a Unix server, then
F-Secure SSH clients must be used for transmittal. If the data are
stored on a Novell server, then data exchange must be limited to a
128 bit encrypted web server.
-
The original copy
of the data supplied by Fast Track is the only backup copy allowed,
and must be kept in a locked compartment separate from the documentation
and access information.
-
Removable storage
devices holding temporary data files must be kept in a locked compartment
when not in use.
-
Printouts derived
from data analysis must be stored in a locked compartment when not
being used. Printed information that is no longer needed should be
shredded before disposal. Printouts of data from Fast Track are not
to be distributed to anyone outside of the research team.
Attachment 2
Sample Security
Pledge for the Use of Data from the Fast Track Project
Pledge
of Confidentiality
I,________________________________________, through my involvement with
and work on the project entitled________________________________, will
have access to data collected by the Fast Track Project. By virtue of
my affiliation with this project, I have access to confidential information
and use of data about respondents generally perceived as personal and
private. I understand that access to this confidential information and
data carries with it responsibility to guard against unauthorized use
and to abide by the data use agreement and data security plan. To treat
information as confidential means not to divulge it to anyone who is not
a project member, or to cause it to be accessible by anyone who is not
a project member. Anything not specifically named as "public information"
is considered confidential.
I agree to fulfill
my responsibilities on this project in accordance with the following guidelines:
- I agree to not
permit non-project personnel access to these data, either electronically
or hard copy.
- I agree to not
attempt to identify individuals, families, households, schools, or institutions.
- I agree that in
the event an identity of an individual, family, household, school, or
institution is discovered inadvertently, I will a) make no use of this
knowledge; b) advise the investigator of the incident who will report
it to Kenneth Dodge (member of the CCPRG and Director, Center for Child
and Family Policy, Duke University); c) safeguard or destroy the information
as directed by the investigator after consultation with Kenneth Dodge;
and d) not inform any other person of the discovered identity.
Name_________________________________________
Title/Responsibilities_____________________________
Signature and Date
______________________________
Supplemental
Agreement with Research Staff
For the Use of Fast Track Data
I. The undersigned research staff, in consideration of their use of sensitive
data from the Fast Track Project, agree:
- That they have
read the associated Data Use Agreement for Fast Track and the Data Security
Plan incorporated by reference into it.
- That they are
"research staff" within the meaning of the agreement.
- To comply fully
with the terms of the Agreement, including the Data Security Plan.
II. The undersigned
investigator agrees that the persons designated herein are research staff
within the meaning of the associated Data Use Agreement from the Fast
Track Project.
Research Staff
____________________________________________________________________
Name Signature Date
____________________________________________________________________
Name Signature Date
____________________________________________________________________
Name Signature Date
____________________________________________________________________
Name Signature Date
____________________________________________________________________
Name Signature Date
____________________________________________________________________
Name Signature Date
Investigator
____________________________________________________________________
Name Signature Date
Attachment 4
Description
of Deductive Disclosure Risk from the Fast Track Project
Restrictions on the
use of data from the Fast Track Project stem from the level of sensitivity
of the data, where "sensitive data" are defined as any data
from a research project that may compromise the anonymity or privacy of
respondents. Fast Track Project staff has taken all appropriate steps
to remove direct and indirect identifying information from the data files.
In order to further safeguard the privacy and anonymity of respondents,
plans for use of Fast Track data must address the risk of deductive disclosure-the
discerning of individual respondent's identity and responses through the
use of known characteristics of that individual. The problem of deductive
disclosure is not unique to Fast Track; this has become a major concern
of federal agencies, researchers, and Institutional Review Boards in the
recent past. If a person is known to have participated in a study or survey,
then a combination of recorded characteristics may permit identification
of a particular respondent. The Fast Track data are more sensitive than
many other datasets to deductive disclosure, for the following reasons:
- The Fast Track
project has as its primary aim to evaluate the effects of study interventions
on a sample of children who are at high risk of severe conduct problems
from early childhood through adolescence. By definition, inclusion in
the study sample places participants in a behavioral category that may
carry negative connotations. Therefore, privacy protections must extend
not only to the contents of data records for respondents, but also to
their actual participation in the study.
- The subject selection
process used in the study increases the number of persons aware of the
study and of the criteria for inclusion in the sample. The sample selection
pool was established through application of a screening instrument on
behavior problems as observed in the kindergarten year of each of three
successive cohorts of children. The in-school procedure for sample selection
involves the participation of persons outside of the project staff (teachers
and, indirectly, school administrators), thus presenting further issues
of respondent anonymity.
- Given that behavior
problems in young children and adolescents are multiply determined,
Fast Track involves a multicomponent preventive intervention program.
Over the study period, the interventions have included: classroom-administered
curricula, parent/child group meetings, individual tutoring, home visits,
and sessions with school guidance counselors and peer mentors. Thus,
the intervention study, by design, increases the pool of persons who
are aware of the study and have had some contact with its participants.
- The multisite and
longitudinal design aspects of Fast Track increase the sensitivity of
the data to deductive disclosure. Within the four sites, schools were
selected according to demographic characteristics of the school populations
and the neighborhoods they served. Therefore, the study involves a potentially
identifiable subset of schools. Over the years the study has collected
detailed demographic and descriptive information for individual participants,
including race, ethnicity, family composition, employment, and attributes
of parents and siblings. School records included in the Fast Track data
provide information on characteristics such as retention and self-contained
classroom placement, which involve a relatively small numbers of students.
- Privacy issues
stem also from the content of some of the data collected by Fast Track.
Highly sensitive data include health conditions, sexual activity, family
information, and illegal behaviors. Fast Track data also include information
about substance abuse and psychological adjustment. Involuntary disclosures
could expose subjects and their families to adverse economic, legal,
psychological, and social consequences.
Given the large number
of contacts with and among study participants, as well as the sensitive
nature of the data, researchers who use the Fast Track data must protect
respondents from deductive disclosure risk by taking extraordinary precautions
to protect the data from non-authorized use. These precautions include
using the data solely for statistical purposes, signing pledges of confidentiality,
and fully abiding by the terms established in the Data Use Agreement and
Data Security Plan.
(Printer-Friendly
Version)
Application
for Obtaining Sensitive Data from the Fast Track Project
Fast Track Data Center
Duke University
Date of Application:______________________________________________________
Name and Title of Investigator ______________________________________________
(Please attach a copy of your Curriculum Vita)
Academic Department____________________________________________________
Name and Address of
Receiving Institution:____________________________________
Title of Research
Project:__________________________________________________
Telephone Number:______________Fax
Number:_______________________________
Email Address:___________________________________________________________
Data Requested:__________________________________________________________
________________________________________________________________________
Date Data to be Destroyed_______________(Upon
completion of the research or within a
specified period following completion.)
Only fully completed
requests will be processed. Please send completed applications to:
Fast Track Data Center
Duke University
Box 90539
Durham, NC 27705
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