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Conduct DisorderNCT01653535

Multisite Prevention of Conduct Problems (Fast Track)

A study testing Fast Track in people with Conduct Disorder and Anti-Social Behavior, run by Duke University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Conduct Disorder, Anti-Social Behavior
What is being tested?
Fast Track
Could I receive a placebo?
No, everyone receives an active treatment
How many people
891 participants
Where
1 siteUnited States
Study dates
Mar 1991to Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Fast Track
Keywords
Prevention, Health Service Use, Behavioral Intervention, Conduct Problems, Anti-Social Behavior
Medical subject headings
Conduct Disorder, Antisocial Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast TrackBehavioural

    Also called Conduct Problems Prevention Research Group

    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.

Study groups in NCT01653535
Study groupRoleWhat they receive
Fast Track EligibleExperimentalParticipants 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.
Receives: Behavioral: Fast Track
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-Social Behaviors

    Assessment of participant rates of anti-social behaviors (e.g., fighting, criminal activity)

    Measured: Grades 1-12 and Ages 19, 20, 25, 32, 34, 41

Secondary outcomes (9)
  1. Substance Usage

    Assessment of participant drug, alcohol, and tobacco use (e.g., any use, frequency of use).

    Measured: Grades 6-12 and Ages 19, 20, 25, 32, 34, 41

  2. Sexual Activity

    Assessment of participant engagement in various sexual activities (e.g., sexual intercourse).

    Measured: Grades 6-12 and Ages 19, 20, 25, and 32

  3. Psychiatric Disorders

    Assessment of participant rates of psychiatric disorders (e.g., clinical depression).

    Measured: Grades 6-12 and Ages 19, 20, 25, 32, and 34

  4. Academic Achievement

    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.

    Measured: Grades 1-12 and Ages 19, 20, 25, 32, and 34

  5. Financial Well-Being

    Assessment of participants employment history, income, assets, and utilization of government services.

    Measured: Grades 10-12 and Ages 19, 20, 25, 32, 34, 41

  6. Physical Health

    Self-reported assessments of the participants physical health.

    Measured: Ages 25, 32, 34, 41

  7. Family Formation and Romantic Partnerships

    Assessments of participants marital/partnership status and children in their households.

    Measured: Grades 10-12 and Ages 19, 20, 25, 32, 34, 41

  8. Parenting Behaviors

    Assessments of participants own parenting behaviors, among participants with children.

    Measured: Ages 25, 32, 34, 41

  9. Characteristics/Behaviors of Participants' Offspring

    Participant-reported information about the behavior and health of their own children.

    Measured: Ages 25, 32, 34, 41

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2012 (estimated)
  2. Study startMar 1991
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
891 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01653535
Sponsor's protocol ID
R01HD093651
Other IDs
5R01DA016903, R01MH117559, R01DA036523, R01DA011301, P30DA023026, S184U30002, R18MH050951, R18MH050952
Status last verified
Feb 2025
First submitted
16 Jul 2012
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 35705512
  • Rothenberg WA, Lansford JE, Godwin JW, Dodge KA, Copeland WE, Odgers CL, McMahon RJ, Rybinska A; Conduct Problems Prevention Research Group. Intergenerational Effects of the Fast Track Intervention on Next-Generation Child Outcomes: A Preregistered Randomized Clinical Trial. Am J Psychiatry. 2024 Mar 1;181(3):213-222. doi: 10.1176/appi.ajp.20220927. Epub 2024 Feb 7.

    PubMed 38321914
  • McCabe G, Godwin JW, Rothenberg WA, Goulter N, Lansford JE; Conduct Problems Prevention Research Group. Fast Track Intervention Effects and Mechanisms of Action Through Established Adulthood. Prev Sci. 2025 May;26(4):667-680. doi: 10.1007/s11121-024-01736-0. Epub 2024 Oct 11.

    PubMed 39392546
  • Lansford JE, Godwin J, Copeland WE, Dodge KA, Odgers CL, Rothenberg WA, Rybinska A; Conduct Problems Prevention Research Group. Fast Track intervention effects on family formation. J Fam Psychol. 2023 Feb;37(1):54-64. doi: 10.1037/fam0001039. Epub 2022 Nov 3.

    PubMed 36326668
  • 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.

    PubMed 20008428
  • 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.

    PubMed 19890487
  • 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.

    PubMed 15498733
  • 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.

    PubMed 12549710
  • 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.

    PubMed 21080053
  • 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.

    PubMed 21291445
  • 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.

    PubMed 20577576
  • 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.

    PubMed 20350027
  • 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.

    PubMed 23406610
  • 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.

    PubMed 23386568
  • 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.

    PubMed 26670938

Questions about this trial

What is this clinical trial studying?

A study testing Fast Track in people with Conduct Disorder and Anti-Social Behavior, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-Social Behaviors (time frame: Grades 1-12 and Ages 19, 20, 25, 32, 34, 41). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01653535, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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