Trial Outcomes & Findings for The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention (NCT 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

three to six months post baseline

Results posted on

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

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

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

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=99 Participants	33.8 years STANDARD_DEVIATION 11.8 • n=107 Participants	33.4 years STANDARD_DEVIATION 10.9 • n=206 Participants
Sex: Female, Male Female	23 Participants n=99 Participants	14 Participants n=107 Participants	37 Participants n=206 Participants
Sex: Female, Male Male	30 Participants n=99 Participants	38 Participants n=107 Participants	68 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	21 Participants n=99 Participants	24 Participants n=107 Participants	45 Participants n=206 Participants
Race (NIH/OMB) White	24 Participants n=99 Participants	26 Participants n=107 Participants	50 Participants n=206 Participants
Race (NIH/OMB) More than one race	8 Participants n=99 Participants	2 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	53 participants n=99 Participants	52 participants n=107 Participants	105 participants n=206 Participants
Psychopathy Checklist-Revised - Factor One (F1)	8.1 units on a scale STANDARD_DEVIATION 4.3 • n=99 Participants	9.0 units on a scale STANDARD_DEVIATION 4.4 • n=107 Participants	8.6 units on a scale STANDARD_DEVIATION 4.3 • n=206 Participants

PRIMARY outcome

Timeframe: three to six months post baseline

Population: 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

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 months

A 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

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 year

New criminal charge vs. no new criminal charge at follow-up as indicated by county database.

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc T. Swogger, Ph.D.

University of Rochester

Phone: 585-275-7418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place