Trial Outcomes & Findings for The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention (NCT NCT01532934)
NCT ID: NCT01532934
Last Updated: 2016-12-12
Results Overview
Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.
COMPLETED
PHASE2
105 participants
three to six months post baseline
2016-12-12
Participant Flow
Recruitment took place at a jail diversion program in Upstate NY between 2009 and 2014.
Inclusion criteria were harmful substance use in the past 6 months and enrollment in a jail diversion program subsequent to being charged with a crime.
Participant milestones
| Measure |
Brief Therapy
motivational enhancement therapy for substance use
motivational enhancement therapy: Four 45-minute MET sessions
|
Standard Care
standard care
standard care: standard care
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
Brief Therapy
motivational enhancement therapy for substance use
motivational enhancement therapy: Four 45-minute MET sessions
|
Standard Care
standard care
standard care: standard care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
|
Overall Study
In controlled environment
|
3
|
2
|
Baseline Characteristics
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
Baseline characteristics by cohort
| Measure |
Brief Motivational Intervention Plus Standard Care (BMI+SC)
n=53 Participants
Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
|
Standard Care (SC)
n=52 Participants
Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 10 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Psychopathy Checklist-Revised - Factor One (F1)
|
8.1 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: three to six months post baselinePopulation: 105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.
Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.
Outcome measures
| Measure |
BMI+SC
n=36 Participants
1. brief MI + standard care
2. standard care
|
Standard Care
n=37 Participants
Assessment only plus the usual range of pretrial services
|
|---|---|---|
|
Percent Days Abstinent Per Month From Drug Use
|
46.92 percentage of days abstinent
Standard Deviation 37.46
|
55.16 percentage of days abstinent
Standard Deviation 42.09
|
SECONDARY outcome
Timeframe: six monthsA measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.
Outcome measures
| Measure |
BMI+SC
n=36 Participants
1. brief MI + standard care
2. standard care
|
Standard Care
n=37 Participants
Assessment only plus the usual range of pretrial services
|
|---|---|---|
|
Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)
|
10.69 units on a scale
Standard Deviation 13.21
|
15.24 units on a scale
Standard Deviation 14.28
|
SECONDARY outcome
Timeframe: one yearNew criminal charge vs. no new criminal charge at follow-up as indicated by county database.
Outcome measures
| Measure |
BMI+SC
n=36 Participants
1. brief MI + standard care
2. standard care
|
Standard Care
n=37 Participants
Assessment only plus the usual range of pretrial services
|
|---|---|---|
|
New Criminal Charge
|
23 participants
|
22 participants
|
Adverse Events
Brief Motivational Intervention Plus Standard Care
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place