Trial Outcomes & Findings for Voucher-Based Incentives in a Prevention Setting (NCT NCT00607269)
NCT ID: NCT00607269
Last Updated: 2013-08-01
Results Overview
Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
131 participants
Primary outcome timeframe
24 Weeks
Results posted on
2013-08-01
Participant Flow
Recruitment occurred from April 2005 through Feb 2008 via flyers posted throughout the community, and word of mouth.
Participant milestones
| Measure |
Control
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
64
|
|
Overall Study
COMPLETED
|
67
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Voucher-Based Incentives in a Prevention Setting
Baseline characteristics by cohort
| Measure |
Control
n=67 Participants
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 Participants
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
36.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
64 participants
n=7 Participants
|
131 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksParticipants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1
Outcome measures
| Measure |
Control
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 Participants
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Amount ($) Earned for Targeted Prosocial and Healthy Behaviors
|
—
|
16.21 $ Vouchers
Standard Deviation 11.85
|
PRIMARY outcome
Timeframe: 24 WeeksOutcome measures
| Measure |
Control
n=67 Participants
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 Participants
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.
|
0.36 Proportion of Lvl 1 Clean Urine Samples
|
0.61 Proportion of Lvl 1 Clean Urine Samples
|
SECONDARY outcome
Timeframe: 12 monthsAs measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory. The GSI combines information on both the number of symptoms described and the severity of those symptoms. Lower values on the GSI indicate less severe symptoms. Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31. Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.
Outcome measures
| Measure |
Control
n=67 Participants
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 Participants
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Self-reported Psychiatric Symptoms at 12-month Follow-up.
|
1.01 Units of General Severity Index
Standard Deviation 0.78
|
0.60 Units of General Severity Index
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: 12 monthsCount of recent (past 30 days) male sexual partners.
Outcome measures
| Measure |
Control
n=67 Participants
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 Participants
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Self-reported Sexual Behaviors at 12-month Follow-up
|
3.33 Sexual Partners
Standard Deviation 9.7
|
0.70 Sexual Partners
Standard Deviation 1.1
|
Adverse Events
Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Contingency Management
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=67 participants at risk
Control condition receiving minimal incentives for service program attendance and participation.
|
Contingency Management
n=64 participants at risk
Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA \< 0.05).
|
|---|---|---|
|
Surgical and medical procedures
Gall Bladder Surgery
|
1.5%
1/67 • Number of events 1
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
Sprained Ankle
|
1.5%
1/67 • Number of events 1
|
0.00%
0/64
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/67
|
1.6%
1/64 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Jesse B. Fletcher, Ph.D., Statistician
Friends Research Institute, Inc.
Phone: 323-463-1601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place