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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a comprehensive intervention aimed at preventing severe conduct issues in children identified as high-risk when they start school. The intervention, called "Fast Track," includes school-based activities, home visits, and a classroom prevention program to improve long-term outcomes like behavior and social skills. Eligible children are those in the first grade at public schools in four specific locations. Participants in the experimental group will receive the Fast Track intervention, while those in the control group will continue with usual services for comparison.

As an unphased trial, this study offers families a unique opportunity to contribute to research that could shape future educational and behavioral interventions.

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.

What prior data suggests that this intervention is safe for children?

Previous studies have shown promising results for the safety and effectiveness of the Fast Track program. Research indicates that this program, designed for children at risk of behavior issues, has successfully reduced mental health disorders and substance use problems. Participants in these studies did not report significant negative side effects.

The Fast Track program includes activities at school and home visits. It aims to reduce behavior problems and improve social skills. Thorough testing in other studies suggests that children handle the treatment well.

Overall, existing research suggests that the Fast Track program is a safe option for addressing behavior problems in high-risk children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fast Track intervention for conduct disorder because it offers a comprehensive approach that involves both children and their support systems. Unlike traditional treatments, which often focus solely on the individual child, Fast Track integrates school-based curriculum, home visits, and the in-class PATHS prevention program to address the broader environment influencing behavior. This holistic method aims to not only improve the child's conduct but also foster a supportive community around them, potentially leading to more sustainable behavioral changes.

What evidence suggests that the Fast Track intervention is effective for conduct disorder?

Research shows that the Fast Track program, which participants in the experimental group of this trial will receive, helps reduce behavior problems and aggression in children. One study found that for the highest-risk group in Grade 9, the program prevented 75% of conduct disorder cases. Earlier research also shows that Fast Track reduced aggressive and disruptive behaviors in elementary school. The program significantly impacted preventing behavior issues in children and teens. These results suggest that Fast Track can be a powerful tool in promoting positive behavior and reducing long-term problems in high-risk children. ^{1 3 6 7 8}

Who Is on the Research Team?

John E Lochman, PhD

Principal Investigator

University of Alabama at Birmingham

Robert J McMahon, PhD

Principal Investigator

Simon Fraser University

Daniel M Crowley, PhD

Principal Investigator

Penn State University

Karen L Bierman, PhD

Principal Investigator

Penn State University

Mark T Greenberg, PhD

Principal Investigator

Penn State University

Ellen E Pinderhughes, PhD

Principal Investigator

Tufts 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

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

I am in kindergarten or 1st grade.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3682774/

The Effects of the Fast Track Preventive Intervention on the ... Among the highest risk group (top 3%) in Grade 9, assignment to intervention was responsible for preventing 75% of CD cases, 53% of attention deficit ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12034041/

Fast Track Intervention Effects and Mechanisms of Action ... Specifically, the intervention reduced aggressive behavior and conduct problems in elementary school (CPPRG, 2004).

3. pnas.org pnas.org/doi/10.1073/pnas.2016234117

The Fast Track intervention's impact on behaviors of ... Evaluations of the program to date show that throughout elementary school, random assignment to FT decreased aggressive and disruptive behaviors ...

4. fasttrackproject.org fasttrackproject.org/data-collection/

Data Collection Description The long-term goal of the Fast Track Project is to test the effectiveness of a developmentally based sequence of interventions designed to prevent antisocial ...

5. cebc4cw.org cebc4cw.org/program/fast-track-project/

CEBC » Program › Fast Track Project Results indicated the Fast Track intervention had a statistically significant and clinically meaningful positive effect on preventing childhood and adolescent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4809761/

How Does the Fast Track Intervention Prevent Adverse ... Fast Track has been evaluated through a randomized controlled trial that has demonstrated positive impact on antisocial outcomes through age 25 (CPPRG, 2015). A ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01653535

Multisite Prevention of Conduct Problems (Fast Track) 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 ...

8. ies.ed.gov ies.ed.gov/ncee/wwc/InterventionReport/628

WWC | Fast Track: Elementary School Fast Track is a comprehensive intervention program designed to reduce conduct problems and promote academic, behavioral, and social improvement.