Fast Track Intervention for Conduct Disorder

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Older than 1st grade, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

891 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is the Fast Track Intervention for Conduct Disorder safe for humans?

The safety of treatments for conduct disorder, like the Fast Track Intervention, is not well-documented in the provided research. However, some studies mention the use of medications like risperidone and atypical antipsychotics for conduct disorder, which have been studied for their safety and tolerability in children and adolescents. ^{1 2 3 4 5}

How does the Fast Track treatment for conduct disorder differ from other treatments?

The Fast Track treatment is unique because it combines multiple components like classroom programs, social skills training, academic tutoring, parent training, and home visits to address conduct disorder in children. This comprehensive approach targets both the children and their environment, aiming to prevent long-term antisocial behavior by improving social, emotional, and academic skills. ^{6 7 8 9 10}

What data supports the effectiveness of the Fast Track treatment for conduct disorder?

The Fast Track treatment, which includes social skills training, academic tutoring, parent training, and home visiting, has shown positive results in reducing conduct problems in high-risk children. By the end of third grade, 37% of children in the intervention group were free of serious conduct problems compared to 27% in the control group, with improvements noted in both school and home settings. ^{6 8 10 11 12}

Who Is on the Research Team?

Karen L Bierman, PhD

Principal Investigator

Penn State University

Mark T Greenberg, PhD

Principal Investigator

Penn State University

John E Lochman, PhD

Principal Investigator

University of Alabama at Birmingham

Robert J McMahon, PhD

Principal Investigator

Simon Fraser University

Ellen E Pinderhughes, PhD

Principal Investigator

Tufts University

Daniel M Crowley, PhD

Principal Investigator

Penn State University

Jennifer Lansford, PhD

Principal Investigator

Duke University

Kenneth A Dodge, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for first graders in public schools at 4 study sites, identified as high-risk for severe conduct problems. Children must score in the top 40% on the TOCA-R assessment. Those older than first grade are not eligible.

Inclusion Criteria

Must be in public schools in 4 study sites

I am currently in the 1st grade.

Exclusion Criteria

I am in kindergarten or 1st grade.

Could not score in the top 40% on the TOCA-R

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple visits for teacher and parent ratings

Intervention

Participants in the Experimental group received the 'Fast Track' intervention, including school-based curriculum, home visiting, and the in-class PATHS prevention program.

Throughout elementary to high school

Regular school-based sessions and home visits

Follow-up

Participants are monitored for long-term outcomes such as conduct disorder, academic achievement, and social integration.

Ages 19 to 41

Periodic assessments at specified ages

What Are the Treatments Tested in This Trial?

Interventions

• Fast Track

Trial Overview The 'Fast Track' program aims to prevent chronic conduct issues among high-risk children. It will be tested if this intervention positively impacts behavior and prevents negative outcomes like delinquency or school dropout.

How Is the Trial Designed?

Group I: Fast Track Eligible Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

U.S. Department of Education

Collaborator

Trials

87

Recruited

54,500+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preventing Serious Conduct Problems in School-Age Youths: The Fast Track Program. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Merging universal and indicated prevention programs: the Fast Track model. Conduct Problems Prevention Research Group. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the first 3 years of the Fast Track prevention trial with children at high risk for adolescent conduct problems. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Early prevention of externalizing disorders--basic principles and parent-centered approaches to prevention of expansive childhood behavior disorders]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Treatments for aggressive and antisocial children. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Diagnosis and pharmacotherapy of conduct disorder. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Examining the clinical correlates of conduct disorder in youth with bipolar disorder. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Atypical antipsychotics for disruptive behaviour disorders in children and youths. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Initial impact of the Fast Track prevention trial for conduct problems: I. The high-risk sample. Conduct Problems Prevention Research Group. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The implementation of the Fast Track program: an example of a large-scale prevention science efficacy trial. [2023]