Trial Outcomes & Findings for Motivation and Skills for Detained Teen Smokers (NCT NCT01387516)
NCT ID: NCT01387516
Last Updated: 2025-04-30
Results Overview
Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
314 participants
Primary outcome timeframe
6 months post release
Results posted on
2025-04-30
Participant Flow
18 participants who were enrolled and completed the baseline assessment either withdrew or were lost prior to treatment assignment.
Participant milestones
| Measure |
Motivational Intervention/Cognitive Behavioral Therapy
Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusing on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Motivational Interviewing/Self-Help Programming
Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute group Self Help intervention sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA "tools" (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine.
|
Relaxation Intervention/Cognitive Behavioral Therapy
The Relaxation Therapy intervention one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusings on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self-Help Programming
The Relaxation Therapy intervention is one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute group sessions of Self Help intervention, based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA "tools" (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
68
|
79
|
69
|
|
Overall Study
COMPLETED
|
75
|
63
|
75
|
65
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
4
|
Reasons for withdrawal
| Measure |
Motivational Intervention/Cognitive Behavioral Therapy
Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusing on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Motivational Interviewing/Self-Help Programming
Motivational Intervention (MI) is one 60-90 minute individual session focusing on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy. This is followed by two 90 minute group Self Help intervention sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA "tools" (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine.
|
Relaxation Intervention/Cognitive Behavioral Therapy
The Relaxation Therapy intervention one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focusings on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self-Help Programming
The Relaxation Therapy intervention is one 60-90 minute individual session that encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute group sessions of Self Help intervention, based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. Elements incorporated in this intervention include the 12 Steps and the NicA "tools" (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Motivation and Skills for Detained Teen Smokers
Baseline characteristics by cohort
| Measure |
Motivational Intervention/Cognitive Behavioral Therapy
n=80 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Motivational Intervention/Self-Help Programming
n=68 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Relaxation Intervention/Cognitive Behavioral Therapy
n=79 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/ Self-Help Programming
n=69 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
16.65 years
STANDARD_DEVIATION 1.07 • n=5 Participants
|
16.83 years
STANDARD_DEVIATION 1.00 • n=7 Participants
|
16.75 years
STANDARD_DEVIATION 1.13 • n=5 Participants
|
16.46 years
STANDARD_DEVIATION 1.21 • n=4 Participants
|
16.68 years
STANDARD_DEVIATION 1.11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
244 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months post releasePopulation: Participants who received both individual (MI or RT) and group (CBT or SHP) treatment who received 6 month follow-up and who had at least one smoking day were included in this analysis. Non-smokers @ 6 month were excluded.
Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups
Outcome measures
| Measure |
Motivational Interviewing/ Cognitive Behavioral Therapy
n=67 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking
|
Motivational Interviewing/Self Help Programming
n=55 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Relaxation Intervention/Cognitive Behavioral Therapy
n=58 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self Help Programming
n=54 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
|---|---|---|---|---|
|
Cigarette Use, Average # of Cigarettes Per Smoking Day.
|
8.01 days
Standard Deviation 6.52
|
8.87 days
Standard Deviation 9.07
|
8.89 days
Standard Deviation 7.29
|
7.55 days
Standard Deviation 6.35
|
PRIMARY outcome
Timeframe: 6 months post releasePopulation: All participants that supplied biochemical markers. If a participant was lost at 3 month follow up; Baseline biochemical markers were included in analysis. When a participant was lost at 6 month follow up, 3 month biochemical markers were used in analysis. 1 participant in the RT/SHP arm never submitted biochemical markers and is not included.
A smokelyzer and a saliva sample are used to get information on CO levels and cotinine in the saliva as biochemical markers for our research. These levels will determine if the participant is verified as being abstinent from smoking during the week before collection.
Outcome measures
| Measure |
Motivational Interviewing/ Cognitive Behavioral Therapy
n=80 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking
|
Motivational Interviewing/Self Help Programming
n=68 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Relaxation Intervention/Cognitive Behavioral Therapy
n=79 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self Help Programming
n=68 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
|---|---|---|---|---|
|
Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva
|
15 Participants
|
15 Participants
|
18 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 6 months post releasePopulation: Participants who received individual (MI or RT) and group treatment (CBT or SHP) and who also received a 6 month follow up.
This validated 8 item measure assesses the frequency of experiencing several respiratory symptoms using a 5 point Likert scale from 1, never to 5, every day. The minimum score is 8 indicating no experience of respiratory symptoms and the maximum score is 40 which indicates a high frequency of experiencing respiratory symptoms.
Outcome measures
| Measure |
Motivational Interviewing/ Cognitive Behavioral Therapy
n=75 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking
|
Motivational Interviewing/Self Help Programming
n=63 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Relaxation Intervention/Cognitive Behavioral Therapy
n=75 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self Help Programming
n=65 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
|---|---|---|---|---|
|
American Thoracic Society Questionnaire (ATSQ)
|
16.11 score on a scale
Standard Deviation 6.36
|
16.65 score on a scale
Standard Deviation 6.83
|
15.26 score on a scale
Standard Deviation 6.64
|
15.91 score on a scale
Standard Deviation 6.53
|
PRIMARY outcome
Timeframe: 6 months post releasePopulation: Includes participants who received individual (MI or RT) and group (CBT or SHP) treatment who also had a 6 month follow up and access to cigarettes. Participants who spent all 90 days of this assessment period in a controlled environment where they did not have access to cigarettes were excluded from this analysis.
Using a Time-Line Follow-back, we calculated percent smoking days for a 60 day period at 6-month follow-up. This is the percentage of smoking days a participant had out of possible smoking days (days for which the participant was not in a controlled environment where they did not have access to cigarettes).
Outcome measures
| Measure |
Motivational Interviewing/ Cognitive Behavioral Therapy
n=70 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking
|
Motivational Interviewing/Self Help Programming
n=55 Participants
Motivational Intervention (MI) is one 60-90 minute Individual session focused on establishing rapport and building motivation. Followed by two 90 minute Self Help Intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
Relaxation Intervention/Cognitive Behavioral Therapy
n=68 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Cognitive Behavioral Therapy (CBT) group sessions focused on the interrelationship between thoughts, feelings, and behaviors. It is used to address specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
|
Relaxation Intervention/Self Help Programming
n=58 Participants
The Relaxation Therapy intervention is one 60-90 minute individual session, encompassing Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol. This is followed by two 90 minute Self Help intervention group sessions based on the principles of Nicotine Anonymous (NicA), to provide those who use nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free.
|
|---|---|---|---|---|
|
Percent Smoking Days
|
83.20 percentage of smoking days
Standard Deviation 32.53
|
87.34 percentage of smoking days
Standard Deviation 24.68
|
68.17 percentage of smoking days
Standard Deviation 38.75
|
81.62 percentage of smoking days
Standard Deviation 33.22
|
Adverse Events
Motivational Intervention/Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interviewing/Self-Help Programming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Relaxation Intervention/Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Relaxation Intervention/Self-Help Programming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
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