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Multisite Prevention of Conduct Problems (Fast Track)

Primary Purpose

Conduct Disorder, Anti-Social Behavior

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fast Track
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Conduct Disorder focused on measuring Prevention, Health Service Use, Behavioral Intervention, Conduct Problems, Anti-Social Behavior

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be in public schools in 4 study sites
  • must be in 1st grade

Exclusion Criteria:

  • cannot be older than 1st grade
  • could not score in the top 40% on the TOCA-R

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fast Track Eligible

Control Group

Arm Description

Participants in the Experimental group received the "Fast Track" intervention. Intervention included school-based curriculum attended by high-risk children, parents, program staff, and occasionally teachers, home visiting, the the in-class PATHS prevention program.

Participants in the Control group were not eligible to receive the Fast Track intervention. These children received other services as usual, and served as the randomized comparison group for examining Fast Track program impacts

Outcomes

Primary Outcome Measures

Anti-Social Behaviors
Assessment of participant rates of anti-social behaviors (e.g., fighting, criminal activity) in Grades 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Secondary Outcome Measures

Substance Usage
Assessment of participant drug, alcohol, and tobacco use (e.g., any use, frequency of use) in Grades 6, 7, 8, 9, and 10.
Sexual Activity
Assessment of participant engagement in various sexual activities (e.g., sexual intercourse) in Grades 6, 7, 8, 9, and 10.
Psychiatric Disorders
Assessment of participant rates of psychiatric disorders (e.g., clinical depression) in Grades 6, 7, 8, 9, and 10.
Academic Achievement
Assessment of participant academic achievement (e.g., grades, standardized test scores) in Grades 6, 7, 8, 9, and 10.

Full Information

First Posted
July 16, 2012
Last Updated
March 21, 2022
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), U.S. Department of Education, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01653535
Brief Title
Multisite Prevention of Conduct Problems (Fast Track)
Official Title
Multisite Prevention of Conduct Problems
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1991 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), U.S. Department of Education, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this project is to evaluate the effects of a comprehensive intervention to prevent severe and chronic conduct problems in a sample of children selected as high-risk when they first entered school. It is hypothesized that the intervention will have positive effects on proximal child behavior in middle school, and high school affecting long-term adolescent outcomes such as conduct disorder, juvenile delinquency, school dropout, substance use, teen pregnancy, relational competence with peers, romantic partners and parents, education and employment and social and community integration.
Detailed Description
This study is a comprehensive intervention project designed to look at how children develop across their lives by providing academic tutoring and lessons in developing social skills and regulating their behaviors. There can be multiple stressors and influences on children and families that increase their risk levels. In such contexts, some families that experience marital conflict and instability can cause inconsistent and ineffective parenting. These children can sometimes enter school poorly prepared for the social, emotional, and cognitive demands of this setting. Often the child will then attend a school with a high number of other children who are similarly unprepared and are negatively influenced by disruptive classroom situations and punitive teacher practices. Over time, children in these circumstances tend to demonstrate particular behaviors, are rejected by families and peers, and tend to receive less support from teachers, further increasing aggressive exchanges and academic difficulties. Thus, this project is based on the hypothesis that improving child competencies, parenting effectiveness, school context and school-home communications will, over time, contribute to preventing certain behaviors across the period from early childhood through adolescence. Four geographic sites were selected for the study: Durham, NC, a small city with a large low-income population that is primarily African American; Nashville, TN, a moderated-sized city with a mix of low-to-middle income and African American and European-American population; Seattle, WA, a moderate-sized city with a low-to-middle ethnically diverse population; and central PA, a mostly rural area with low-to-middle income European American population. These sites varied widely in ethnicity (most minorities were African American, with some Latino) and poverty (as measured by free/reduced lunch rates) as follows: Durham, NC, 90% minority and 80% reduced lunch; Nashville, TN, 54% minority and 78% reduced lunch; rural PA; 1% minority and 39% reduced lunch; and Seattle, WA, 52% minority and 46% reduced lunch. "High risk" schools within each site (12 in Durham, 9 in Nashville, 18 in PA, and 16 in Seattle) were selected based on crime and poverty statistics of the communities that they served. Within each site, schools were divided into one to three paired sets matched for demographics (size, percentage free or reduced lunch, and ethnic composition), and one set within each pair was randomly assigned to intervention and one to control condition. Students at these elementary schools moved into middle school at grade 5, 6 or 7. A multiple-gating screening procedure that combined teacher and parent ratings of disruptive behavior was applied to all kindergarteners across three cohorts (1991-93) in these 55 schools. Children were screened initially for classroom conduct problems by teachers, using the Teacher Observation of Child Adjustment-Revised (TOCA-R) Authority Acceptance Score. Those children scoring in the top 40% within cohort and site were then solicited for the next stage of screening for home behavior problems by the parents, using a novel 22-item instrument that included items from the Child Behavior Checklist (Achenbach, 1991a), the Revised Behavior Problem Checklist, and novel items that we created for this study. 91% (n=3,274) completed the home-behavior screen. The teacher and parent screening scores were then standardized within site, based on screening a representative sample of approximately 100 children within each site (which also served as a normative comparison), and then summed to yield a total severity-of-risk screen score. Children were selected for inclusion into this study based on this screen score, moving from the highest score downward until desired sample sizes were reached within sites, cohorts, and conditions. Exceptions to this inclusion rule were made when a child failed to matriculate in the first grade at a core school (n=59) or refused to participate (n=75), or to accommodate a superceding rule that no child would be the only female in an intervention group. The outcome was that three successive cohorts were recruited in 1991, 1992, and 1993 to yield a sample of 891 children (445 in the intervention group and 446 in the control group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Anti-Social Behavior
Keywords
Prevention, Health Service Use, Behavioral Intervention, Conduct Problems, Anti-Social Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
891 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fast Track Eligible
Arm Type
Experimental
Arm Description
Participants in the Experimental group received the "Fast Track" intervention. Intervention included school-based curriculum attended by high-risk children, parents, program staff, and occasionally teachers, home visiting, the the in-class PATHS prevention program.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the Control group were not eligible to receive the Fast Track intervention. These children received other services as usual, and served as the randomized comparison group for examining Fast Track program impacts
Intervention Type
Behavioral
Intervention Name(s)
Fast Track
Other Intervention Name(s)
Conduct Problems Prevention Research Group
Intervention Description
First grade intervention included a weekly two-hour curriculum-based day that was attended by high-risk children, parents, program staff, and teachers of the high-risk children. During each session, the staff modeled academic tutoring with target children in the presence of their parents. In 3rd and 4th grades, intervention consisted of monthly parent and child curriculum-based sessions during the academic year, home visiting, and teachers implementing the in-class PATHS prevention program. In 5th and 6th grades, intervention included monthly parent and child groups and home visiting. In grades 8, 9 and 10 staff developed sessions on an as needed basis to cover topics like transition to high school, note-taking, and study skills.
Primary Outcome Measure Information:
Title
Anti-Social Behaviors
Description
Assessment of participant rates of anti-social behaviors (e.g., fighting, criminal activity) in Grades 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10.
Time Frame
up to 10 Years
Secondary Outcome Measure Information:
Title
Substance Usage
Description
Assessment of participant drug, alcohol, and tobacco use (e.g., any use, frequency of use) in Grades 6, 7, 8, 9, and 10.
Time Frame
6 Years, 7 Years, 8 Years, 9 Years, 10 Years
Title
Sexual Activity
Description
Assessment of participant engagement in various sexual activities (e.g., sexual intercourse) in Grades 6, 7, 8, 9, and 10.
Time Frame
6 Years, 7 Years, 8 Years, 9 Years, 10 Years
Title
Psychiatric Disorders
Description
Assessment of participant rates of psychiatric disorders (e.g., clinical depression) in Grades 6, 7, 8, 9, and 10.
Time Frame
6 Years, 7 Years, 8 Years, 9 Years, 10 Years
Title
Academic Achievement
Description
Assessment of participant academic achievement (e.g., grades, standardized test scores) in Grades 6, 7, 8, 9, and 10.
Time Frame
6 Years, 7 Years, 8 Years, 9 Years, 10 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be in public schools in 4 study sites must be in 1st grade Exclusion Criteria: cannot be older than 1st grade could not score in the top 40% on the TOCA-R
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth A Dodge, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen L Bierman, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark T Greenberg, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John E Lochman, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J McMahon, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen E Pinderhughes, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel M Crowley, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 15 of the study. The full terms of the Fast Track data sharing plan and access criteria exceed the 1000 character limit. Full information about the data-use policy and application forms can be found at http://fasttrackproject.org/request-use-data.php
IPD Sharing Time Frame
Time Frames will vary, depending on the individual research plan.
IPD Sharing Access Criteria
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.
IPD Sharing URL
http://fasttrackproject.org/
Citations:
PubMed Identifier
20008428
Citation
Jones D, Godwin J, Dodge KA, Bierman KL, Coie JD, Greenberg MT, Lochman JE, McMahon RJ, Pinderhughes EE. Impact of the fast track prevention program on health services use by conduct-problem youth. Pediatrics. 2010 Jan;125(1):e130-6. doi: 10.1542/peds.2009-0322. Epub 2009 Dec 14.
Results Reference
result
PubMed Identifier
19890487
Citation
Slough NM, McMahon RJ, Bierman KL, Coie JD, Dodge KA, Foster EM, Greenberg MT, Lochman JE, McMahon RJ, Pinderhughes EE. Preventing Serious Conduct Problems in School-Age Youths: The Fast Track Program. Cogn Behav Pract. 2008 Feb 1;15(1):3-17. doi: 10.1016/j.cbpra.2007.04.002.
Results Reference
result
PubMed Identifier
15498733
Citation
Bierman KL, Coie JD, Dodge KA, Foster EM, Greenberg MT, Lochman JE, McMahon RJ, Pinderhughes EE; Conduct Problems Prevention Research Group. The effects of the fast track program on serious problem outcomes at the end of elementary school. J Clin Child Adolesc Psychol. 2004 Dec;33(4):650-61. doi: 10.1207/s15374424jccp3304_1.
Results Reference
result
PubMed Identifier
12549710
Citation
Bierman KL, Coie JD, Dodge KA, Greenberg MT, Lochman JE, McMahon RJ, Pinderhughes EE; Conduct Problems Prevention Research Group. Using the Fast Track randomized prevention trial to test the early-starter model of the development of serious conduct problems. Dev Psychopathol. 2002 Fall;14(4):925-43. doi: 10.1017/s0954579402004133.
Results Reference
result
PubMed Identifier
21080053
Citation
Kam CM, Greenberg MT, Bierman KL, Coie JD, Dodge KA, Foster ME, Lochman JE, McMahon RJ, Pinderhughes EE; Conduct Problems Prevention Research Group. Maternal depressive symptoms and child social preference during the early school years: mediation by maternal warmth and child emotion regulation. J Abnorm Child Psychol. 2011 Apr;39(3):365-77. doi: 10.1007/s10802-010-9468-0.
Results Reference
result
PubMed Identifier
21291445
Citation
Conduct Problems Prevention Research Group. The effects of the fast track preventive intervention on the development of conduct disorder across childhood. Child Dev. 2011 Jan-Feb;82(1):331-45. doi: 10.1111/j.1467-8624.2010.01558.x.
Results Reference
result
PubMed Identifier
20577576
Citation
Conduct Problems Prevention Research Group. Fast Track intervention effects on youth arrests and delinquency. J Exp Criminol. 2010 Jun;6(2):131-157. doi: 10.1007/s11292-010-9091-7.
Results Reference
result
PubMed Identifier
20350027
Citation
Conduct Problems Prevention Research Group. The effects of a multiyear universal social-emotional learning program: The role of student and school characteristics. J Consult Clin Psychol. 2010 Apr;78(2):156-68. doi: 10.1037/a0018607.
Results Reference
result
PubMed Identifier
23406610
Citation
Dodge KA, Godwin J; Conduct Problems Prevention Research Group. Social-information-processing patterns mediate the impact of preventive intervention on adolescent antisocial behavior. Psychol Sci. 2013 Apr;24(4):456-65. doi: 10.1177/0956797612457394. Epub 2013 Feb 13.
Results Reference
result
PubMed Identifier
23386568
Citation
Bierman KL, Coie J, Dodge K, Greenberg M, Lochman J, McMohan R, Pinderhughes E; Conduct Problems Prevention Research Group. School outcomes of aggressive-disruptive children: prediction from kindergarten risk factors and impact of the fast track prevention program. Aggress Behav. 2013 Mar-Apr;39(2):114-30. doi: 10.1002/ab.21467. Epub 2013 Feb 5.
Results Reference
result
PubMed Identifier
26670938
Citation
Sorensen LC, Dodge KA; Conduct Problems Prevention Research Group. How Does the Fast Track Intervention Prevent Adverse Outcomes in Young Adulthood? Child Dev. 2016 Mar-Apr;87(2):429-45. doi: 10.1111/cdev.12467. Epub 2015 Dec 16.
Results Reference
result
PubMed Identifier
25219348
Citation
Dodge KA, Bierman KL, Coie JD, Greenberg MT, Lochman JE, McMahon RJ, Pinderhughes EE; Conduct Problems Prevention Research Group. Impact of early intervention on psychopathology, crime, and well-being at age 25. Am J Psychiatry. 2015 Jan;172(1):59-70. doi: 10.1176/appi.ajp.2014.13060786. Epub 2014 Oct 31. Erratum In: Am J Psychiatry. 2015 Jan;172(1):100.
Results Reference
result
PubMed Identifier
26106668
Citation
Albert D, Belsky DW, Crowley DM, Latendresse SJ, Aliev F, Riley B, Sun C; Conduct Problems Prevention Research Group; Dick DM, Dodge KA. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial. J Policy Anal Manage. 2015 Summer;34(3):497-518. doi: 10.1002/pam.21811.
Results Reference
result
PubMed Identifier
25640832
Citation
Albert D, Belsky DW, Crowley DM, Bates JE, Pettit GS, Lansford JE, Dick D, Dodge KA. Developmental mediation of genetic variation in response to the Fast Track prevention program. Dev Psychopathol. 2015 Feb;27(1):81-95. doi: 10.1017/S095457941400131X.
Results Reference
result
PubMed Identifier
27817096
Citation
Zheng Y, Albert D, McMahon RJ, Dodge K, Dick D; Conduct Problems Prevention Research Group. Glucocorticoid Receptor (NR3C1) Gene Polymorphism Moderate Intervention Effects on the Developmental Trajectory of African-American Adolescent Alcohol Abuse. Prev Sci. 2018 Jan;19(1):79-89. doi: 10.1007/s11121-016-0726-4.
Results Reference
result
PubMed Identifier
31422489
Citation
Goulter N, McMahon RJ, Dodge KA; Conduct Problems Prevention Research Group. Does the Fast Track Intervention Prevent Later Psychosis Symptoms? Prev Sci. 2019 Nov;20(8):1255-1264. doi: 10.1007/s11121-019-01041-1.
Results Reference
result
PubMed Identifier
33262281
Citation
Godwin JW; Conduct Problems Prevention Research Group. The Fast Track intervention's impact on behaviors of despair in adolescence and young adulthood. Proc Natl Acad Sci U S A. 2020 Dec 15;117(50):31748-31753. doi: 10.1073/pnas.2016234117. Epub 2020 Dec 1.
Results Reference
result
PubMed Identifier
35705512
Citation
Rothenberg WA, Lansford JE, Godwin JW, Dodge KA, Copeland WE, Odgers CL, McMahon RJ, Goulter N; Conduct Problems Prevention Research Group. Intergenerational effects of the Fast Track intervention on the home environment: A randomized control trial. J Child Psychol Psychiatry. 2023 May;64(5):820-830. doi: 10.1111/jcpp.13648. Epub 2022 Jun 15.
Results Reference
derived
Links:
URL
http://fasttrackproject.org/
Description
Project Direct Site
URL
https://childandfamilypolicy.duke.edu/
Description
Related Info

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Multisite Prevention of Conduct Problems (Fast Track)

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