Multisite Prevention of Conduct Problems (Fast Track)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Department of Education
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01653535
First received: July 16, 2012
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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 Intervention
At-risk for Condition Being Studied
Behavioral: Anti-Social Behavior Prevention Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Multisite Prevention of Conduct Problems

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Anti-Social Behaviors [ Time Frame: up to 10 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ] [ Designated as safety issue: No ]
    Assessment of participant engagement in various sexual activities (e.g., sexual intercourse) in Grades 6, 7, 8, 9, and 10.

  • Psychiatric Disorders [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ] [ Designated as safety issue: No ]
    Assessment of participant rates of psychiatric disorders (e.g., clinical depression) in Grades 6, 7, 8, 9, and 10.

  • Academic Achievement [ Time Frame: 6 Years, 7 Years, 8 Years, 9 Years, 10 Years ] [ Designated as safety issue: No ]
    Assessment of participant academic achievement (e.g., grades, standardized test scores) in Grades 6, 7, 8, 9, and 10.


Enrollment: 891
Study Start Date: March 1991
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fast Track Eligible
Participants in the Experimental group received the "Fast Track" intervention. The intervention began in 1991 of the 1st grade year and continued through the end of the 10th grade. The intervention condition is described in detail below.
Behavioral: Anti-Social Behavior Prevention Program
The intervention began in 1991 of the 1st grade year and continued through the end of the 10th grade. A central feature of the program during the first school year was a weekly two-hour curriculum-based day that was attended by high-risk children, parents, program staff, and occasionally teachers of the high-risk children. During each session, the staff modeled academic tutoring with target children in the presence of their parents. In the third and fourth 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. For the 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. After each cohort finished 10th grade, the intervention portion of the project was completed.
Other Names:
  • Fast Track
  • 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

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).

  Eligibility

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653535

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
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
  More Information

Additional Information:
Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01653535     History of Changes
Other Study ID Numbers: 5R01DA016903, 5R01DA016903
Study First Received: July 16, 2012
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014