Multisite Prevention of Conduct Problems (Fast Track)

February 14, 2025 updated by: Duke University

Multisite Prevention of Conduct Problems

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

891

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Social Behaviors
Time Frame: Grades 1-12 and Ages 19, 20, 25, 32, 34, 41
Assessment of participant rates of anti-social behaviors (e.g., fighting, criminal activity)
Grades 1-12 and Ages 19, 20, 25, 32, 34, 41

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Activity
Time Frame: Grades 6-12 and Ages 19, 20, 25, and 32
Assessment of participant engagement in various sexual activities (e.g., sexual intercourse).
Grades 6-12 and Ages 19, 20, 25, and 32
Psychiatric Disorders
Time Frame: Grades 6-12 and Ages 19, 20, 25, 32, and 34
Assessment of participant rates of psychiatric disorders (e.g., clinical depression).
Grades 6-12 and Ages 19, 20, 25, 32, and 34
Academic Achievement
Time Frame: Grades 1-12 and Ages 19, 20, 25, 32, and 34
Assessment of participant academic achievement (e.g., grades, standardized test scores) in grade 1-12. Post-secondary educational attainment collected at ages 19, 20, 25, 32, and 34.
Grades 1-12 and Ages 19, 20, 25, 32, and 34
Substance Usage
Time Frame: Grades 6-12 and Ages 19, 20, 25, 32, 34, 41
Assessment of participant drug, alcohol, and tobacco use (e.g., any use, frequency of use).
Grades 6-12 and Ages 19, 20, 25, 32, 34, 41
Financial Well-Being
Time Frame: Grades 10-12 and Ages 19, 20, 25, 32, 34, 41
Assessment of participants employment history, income, assets, and utilization of government services.
Grades 10-12 and Ages 19, 20, 25, 32, 34, 41
Physical Health
Time Frame: Ages 25, 32, 34, 41
Self-reported assessments of the participants physical health.
Ages 25, 32, 34, 41
Family Formation and Romantic Partnerships
Time Frame: Grades 10-12 and Ages 19, 20, 25, 32, 34, 41
Assessments of participants marital/partnership status and children in their households.
Grades 10-12 and Ages 19, 20, 25, 32, 34, 41
Parenting Behaviors
Time Frame: Ages 25, 32, 34, 41
Assessments of participants own parenting behaviors, among participants with children.
Ages 25, 32, 34, 41
Characteristics/Behaviors of Participants' Offspring
Time Frame: Ages 25, 32, 34, 41
Participant-reported information about the behavior and health of their own children.
Ages 25, 32, 34, 41

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
U.S. Department of Education

Investigators

  • 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
  • Principal Investigator: Daniel M Crowley, PhD, Penn State University
  • Principal Investigator: Jennifer Lansford, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1991

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimated)

July 31, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD093651 (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)
  • R01MH062988 (U.S. NIH Grant/Contract)
  • R01MH117559 (U.S. NIH Grant/Contract)
  • K05MH000797 (U.S. NIH Grant/Contract)
  • R01DA036523 (U.S. NIH Grant/Contract)
  • R01DA011301 (U.S. NIH Grant/Contract)
  • K05DA015226 (U.S. NIH Grant/Contract)
  • RC1DA028248 (U.S. NIH Grant/Contract)
  • P30DA023026 (U.S. NIH Grant/Contract)
  • S184U30002 (Other Grant/Funding Number: Department of Education)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 collected in grades K-12 and at ages 19, 20, 25, 32 and 34.

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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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