Multisite Prevention of Conduct Problems (Fast Track)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653535
Recruitment Status : Active, not recruiting
First Posted : July 31, 2012
Last Update Posted : October 13, 2017
National Institute on Drug Abuse (NIDA)
U.S. Department of Education
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Conduct Disorder Anti-Social Behavior Behavioral: Fast Track Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Multisite Prevention of Conduct Problems
Study Start Date : March 1991
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Fast Track Eligible
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.
Behavioral: Fast Track
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.
Other Name: Conduct Problems Prevention Research Group

No Intervention: Control Group
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

Primary Outcome Measures :
  1. Anti-Social Behaviors [ Time Frame: up to 10 Years ]
    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 :
  1. Substance Usage [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ]
    Assessment of participant drug, alcohol, and tobacco use (e.g., any use, frequency of use) in Grades 6, 7, 8, 9, and 10.

  2. Sexual Activity [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ]
    Assessment of participant engagement in various sexual activities (e.g., sexual intercourse) in Grades 6, 7, 8, 9, and 10.

  3. Psychiatric Disorders [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ]
    Assessment of participant rates of psychiatric disorders (e.g., clinical depression) in Grades 6, 7, 8, 9, and 10.

  4. Academic Achievement [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ]
    Assessment of participant academic achievement (e.g., grades, standardized test scores) in Grades 6, 7, 8, 9, and 10.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653535

United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
U.S. Department of Education
National Institute of Mental Health (NIMH)
Principal Investigator: Kenneth A Dodge, PhD Duke University
Principal Investigator: Karen L Bierman, PhD Penn State University
Principal Investigator: Mark T Greenberg, PhD Penn State University
Principal Investigator: John E Lochman, PhD University of Alabama at Birmingham
Principal Investigator: Robert J McMahon, PhD Simon Fraser University
Principal Investigator: Ellen E Pinderhughes, PhD Tufts University

Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT01653535     History of Changes
Other Study ID Numbers: 5R01DA016903 ( U.S. NIH Grant/Contract )
5R01DA016903 ( U.S. NIH Grant/Contract )
R18MH048043 ( U.S. NIH Grant/Contract )
R18MH050951 ( U.S. NIH Grant/Contract )
R18MH050952 ( U.S. NIH Grant/Contract )
R18MH050953 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Duke University:
Health Service Use
Behavioral Intervention
Conduct Problems
Anti-Social Behavior

Additional relevant MeSH terms:
Conduct Disorder
Antisocial Personality Disorder
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Personality Disorders