Trial Outcomes & Findings for Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail (NCT NCT00506753)

NCT ID: NCT00506753

Last Updated: 2019-05-15

Results Overview

using Time-Line Follow-back, we collected average # of drinks per week for a 3 month period at Baseline, 3 months and 6 months post release

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 205 participants
• Primary outcome timeframe: Baseline, 3 months post release and 6 months post release
• Results posted on: 2019-05-15

Participant Flow

6 participants withdrew or could not be located prior to treatment assignment.

Participant milestones

Measure	MI/CBT Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual
Overall Study STARTED	100	99
Overall Study COMPLETED	79	84
Overall Study NOT COMPLETED	21	15

Reasons for withdrawal

Measure	MI/CBT Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual
Overall Study Lost to Follow-up	21	15

Baseline Characteristics

Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail

Baseline characteristics by cohort

Measure	MI/CBT n=100 Participants Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU n=99 Participants Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual	Total n=199 Participants Total of all reporting groups
Age, Continuous	17.05 years STANDARD_DEVIATION 1.01 • n=5 Participants	17.11 years STANDARD_DEVIATION 1.08 • n=7 Participants	17.08 years STANDARD_DEVIATION 1.04 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	91 Participants n=7 Participants	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	47 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	52 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	99 participants n=7 Participants	199 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months post release and 6 months post release

Population: Individuals dropped out of the project over time, more people were analyzed at Baseline than at each Follow-up assessment.

using Time-Line Follow-back, we collected average # of drinks per week for a 3 month period at Baseline, 3 months and 6 months post release

Outcome measures

Measure	MI/CBT n=100 Participants Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU n=98 Participants Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual
Alcohol Use, Average # of Drinks Per Week Average # of drinks per week at Baseline	11.16 average # of drinks per week Standard Deviation 19.04	10.62 average # of drinks per week Standard Deviation 17.02
Alcohol Use, Average # of Drinks Per Week Average # of drinks per week 3 months post release	5.16 average # of drinks per week Standard Deviation 12.27	3.86 average # of drinks per week Standard Deviation 9.16
Alcohol Use, Average # of Drinks Per Week Average # drinks per week at 6 months post release	7.08 average # of drinks per week Standard Deviation 13.69	3.57 average # of drinks per week Standard Deviation 7.57

PRIMARY outcome

Timeframe: Baseline, 3 months post release and 6 month post release

Population: Individuals dropped out of the study over time, more people were analyzed at baseline than at follow up assessments

using Time-Line Follow-back, we collected average number of joints per smoking day

Outcome measures

Measure	MI/CBT n=100 Participants Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU n=98 Participants Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual
Marijuana Use # of joints per smoking day at baseline	5.84 # of joints per smoking day Standard Deviation 5.57	4.98 # of joints per smoking day Standard Deviation 4.25
Marijuana Use # of joints per smoking day at 3 months	2.52 # of joints per smoking day Standard Deviation 2.37	2.48 # of joints per smoking day Standard Deviation 2.49
Marijuana Use # of joints per smoking day at 6 months	2.48 # of joints per smoking day Standard Deviation 2.16	2.95 # of joints per smoking day Standard Deviation 3.71

PRIMARY outcome

Timeframe: Baseline, 3 months post release and 6 months post release

Population: Due to project drop out more people were analyzed at baseline than at both follow up assessments.

using the Misbehaviors Questionnaire, we collect 12 items that assess the average number of times crimes involving predatory aggression were committed at Baseline, 3 months and 6 month post release.

Outcome measures

Measure	MI/CBT n=100 Participants Motivational Interviewing followed by Cognitive Behavior Therapy MI/CBT: Motivational Interviewing followed by Cognitive Behavior Therapy	RT/TU n=99 Participants Relaxation Training followed by Treatment as Usual RT/SU: Relaxation Training followed by Treatment as Usual
Crime: General Predatory Aggression 6 month avg. # times of predatory aggression	6.35 Average # of times Standard Deviation 3.72	1.92 Average # of times Standard Deviation 2.41
Crime: General Predatory Aggression 3 month post avg. # times of predatory aggression	2.13 Average # of times Standard Deviation 2.69	1.92 Average # of times Standard Deviation 2.41
Crime: General Predatory Aggression 6 month post avg. # times of predatory aggression	1.89 Average # of times Standard Deviation 2.71	1.44 Average # of times Standard Deviation 2.03

Adverse Events

MI/CBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RT/TU

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

Dr. Lynda Stein, Ph.D.

University of Rhode Island

Phone: 401-874-5562

Email: lynda_stein@uri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place