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Behavioral Intervention
Forging New Paths for Mental Illness (FNP Trial)
N/A
Recruiting
Led By Amy Wilson, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3 through month 9
Awards & highlights
Summary
This trial aims to test a program called Forging New Paths for people with mental illness who have been in contact with the criminal legal system. The trial will examine if this program can reduce aggression and improve
Who is the study for?
This trial is for individuals with mental health disorders who have had contact with the criminal legal system. They must pass a screening interview to participate. The study will involve those willing to be randomly assigned to either the new intervention, Forging New Paths plus usual care, or to receive usual care alone.
What is being tested?
The clinical trial is testing 'Forging New Paths,' an intervention aimed at reducing aggression and increasing community tenure among people with mental illness. It compares this approach against standard care practices by assessing changes in impulsivity and criminal attitudes.
What are the potential side effects?
Since 'Forging New Paths' is a behavioral intervention rather than a medication, it may not have typical side effects. However, participants might experience emotional discomfort or stress during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3 through month 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3 through month 9
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Levels of Aggression Score From Baseline to Month 6
Change in Levels of Aggression Score from Baseline to Month 3
Community Tenure
Secondary outcome measures
Change in Overall Criminal Attitudes Score
Change in Overall Impulsivity Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Forging New Paths + Usual CareExperimental Treatment1 Intervention
The experimental condition receives Forging New Paths in addition to community based mental health services as determined by their treatment providers.
Group II: Control: Usual Care AloneActive Control1 Intervention
The control condition receives community based mental health services as determined by their treatment providers.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,868 Previous Clinical Trials
2,777,414 Total Patients Enrolled
10 Trials studying Mental Health Disorders
4,878 Patients Enrolled for Mental Health Disorders
University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,970 Total Patients Enrolled
Amy Wilson, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
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