CClinicalTrials.gg
CompletedNCT01387516Updated Apr 30, 2025Results posted

Motivation and Skills for Detained Teen Smokers

An interventional study of Motivational Intervention and Relaxation Therapy in Motivational Intervention, Nicotine Anonymous and Cognitive Behavior Therapy, sponsored by University of Rhode Island. Completed at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by University of Rhode Island · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jul 2007, registered May 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
314
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
All
01

Study summary

The long-term objective of this research is to increase the investigators understanding of effective smoking interventions for understudied adolescents at high risk for continued smoking into adulthood.

This randomized clinical trial uses a 2 x 2 between groups design to investigate Motivational Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior Therapy (CBT) versus Self-Help Programming (SHP). Treatments are provided during brief stay in detention and adolescents are followed after release. The investigators seek to increase quit rates post-release, and the investigators will examine the moderating and mediating effects of motivation, anger, and self-efficacy. The investigators will study main effects for treatment as well as whether the combination of MI/CBT is more effective than other treatments in enhancing quit rates.

Frequently, treatment for smoking cessation is unavailable to youths in the juvenile justice system, and when treatment is available, it may be provided using untested therapies. This study extends previous research by rigorously evaluating smoking cessation interventions specifically for teens at highest risk for continued smoking in adulthood. The investigators will examine processes contributing to the efficacy of treatments. The development of effective smoking interventions for juvenile detainees has the potential to reduce a significant public health concern in this undeserved and high-risk population.

Read the detailed description

Research efforts to affect adolescent smoking cessation have not focused on detained teens. This is an opportune time to enhance interest in smoking cessation and subsequent quit rates. In addition, little is known about mechanisms of smoking cessation in adolescents, generally. The long-term objective of this research is to increase our understanding of effective smoking interventions for understudied adolescents at high risk for continued smoking into adulthood.

This Randomized Clinical Trial (RCT) uses a 2 x 2 between groups factorial design to investigate Motivational Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior Therapy (CBT) versus Self-Help Programming (SHP). Treatments are provided during brief stay in detention and adolescents are followed after release. The investigators seek to increase quit rates post-release, and the investigators will examine the moderating and mediating effects of motivation, anger, and self-efficacy. The investigators will study main effects for treatment as well as whether the combination of MI/CBT is more effective than other treatments in enhancing quit rates.

Methodology-Adolescents ages 13-19, who have been detained at the Rhode Island Training School (RITS; ethnic breakdown: 32% Caucasian, 35% African American, 22% Latino, 5% Asian American, and 6% of other racial backgrounds),and approximately 10% of its residents are female. Adolescents will be eligible if: 1) they smoke an average of 1 cigarette or cigarillo per day 2) they have an estimated length of 4-7 weeks stay in detention.

All teens who meet the inclusion criteria will be initially introduced to the study by Rhode Island Training School (RITS) authorized personnel who will briefly explain the study. Youth will be approached in person at the facility and if interested in the study, project staff describes the purposes, procedures, and answers all questions the youth may have.It is also emphasized that to not participate will not result in any repercussions in terms of their detention to the facility.

In order to participate in the study, eligible teens will be required to read (or have read) and sign an informed consent/assent form. Teens not meeting screening criteria or who decline participation in the study will be thanked for their time. Teens who meet the inclusion criteria, but decline participation will be asked to fill out a brief, anonymous questionnaire containing demographic information and items concerning previous incarcerations. If they agree to do so, they will be asked to read and sign an informed consent/assent form. The purpose of this brief questionnaire is to allow us to determine if the sample of teens that agreed to participate is significantly different from those who declined.

After obtaining informed consent/assent, Youth complete the baseline assessment which takes approximately 105 minutes to complete. All information will be collected during an interview with a trained Research Assistant (RA), including an orientation to the project. These assessments are identical for all conditions and will occur within 24 hrs. of consent/assent at the RITS.

Contact information including; addresses, numbers, nicknames, employer info., and school info, driver's license numbers, case workers (CW), probation officers (PO), and two family or friends who would be able to locate them will be recorded.Locator information will include name, address, and phone number, relation to the teen.Youth will be asked to sign a letter addressed to their locators that explains that they are participating in a research project at the University of Rhode Island (URI) and that they have given permission for the locator to provide project staff with information to locate him/her.This letter provides no information about the nature of the project.Locators will be contacted only if all other attempts to reach the teen have failed.

Youth are then urn randomized to receive either one individual session of Motivational Interviewing (MI) or Relaxation Therapy (RT). To optimize our chances of establishing a causal relationship between the treatment conditions and differential treatment outcome urn randomization is be employed. For our purposes age (\<16 vs. > 16),family history of smoking (none vs. first degree biological relatives), and childhood onset conduct disorder with aggressive symptoms (yes vs. no) will factor into the urn randomization procedure, making it more likely that groups will balance on these variables.

The MI session is 60-90 minutes in length, with focus 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 expectancy, and perceptions of self-efficacy. A personalized feedback report outlines assessment results, highlights any problems or concerns related to cigarette use expressed by teen, and compares tobacco use levels with national norms for same age and gender peers.

The RT condition is designed to be comparable in time to the MI, thus participants in this condition will meet individually with a therapist for 60-90 minutes on one occasion. These sessions will focus on instruction in muscle relaxation and meditation, and youth will be given feedback and handouts on use of relaxation techniques. This relaxation training protocol has been used as a treatment condition in a number of Institutional Review Board (IRB) approved intervention studies.

After receiving one individualized treatment, youth are then randomized to one of two different group interventions.

Cognitive Behavioral Therapy (CBT) sessions will focus on training a variety of skills including problem solving, coping, refusal of tobacco, communication, identification of appropriate support networks, and developing a personal emergency plan for after release. Each of these two group sessions at 60-75 minutes in length.

Self-Help Programming (SHP) utilizes a Nicotine Anonymous (NicA) approach to group treatment. Therefore, the 12-step philosophy, tools and traditions of NicA, and what is gained by giving up nicotine are discussed along with tips for not smoking. Each of these two group sessions are 60-75 minutes in length.

A thirty minute Post-Individual Assessment (FFU1) occurs after the individual MI or RT session. A 45 minute Post-Group Assessment (FFU2) occurs at the end of the youth's last group session. These assessments are conducted by a Research Assistant (RA) blind to treatment assignment.These assessments tap retention of experimental treatment effects.Incentives include snacks and individual attention.

A RA will schedule a post-release three month follow up assessment prior to the youth's release from RITS. The assessment will vary depending on when the teen is released, however the assessment will take place 3 months after the release date for each teen. The remaining Follow up is six months post release and is scheduled by the RA conducting the previous session. Each follow-up assessments are approximately 60-90 minutes in length and will be conducted in person in a private office at the University of Rhode Island, by a trained RA. Assessments consist of questions regarding post-release behaviors such as previous charges, smoking, and self-efficacy, and will utilize the same measures used in the baseline assessment.

02

Conditions studied

  • Motivational Intervention
  • Nicotine Anonymous
  • Cognitive Behavior Therapy
  • Relaxation Therapy

Keywords

  • nicotine
  • juveniles
  • detention
03

In context

Lead sponsor

University of Rhode Island is the lead sponsor of 34 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 13-19 years old,
  • smokes average of 1 cigarette or cigarillo per day
  • in facility for at least 4 days.

Exclusion criteria

Exclusion Criteria:

  • non-smoker,
  • not in facility long enough (i.e. 4 days).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Care provider)
Enrollment
314 participants (actual)

Study arms

  • Experimental
    Motivational Intervention

    Motivational Interviewing (MI) will be a 60-90 minutes individual session.The focus is on establishing rapport and building motivation. The counselor explores youth's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancy, and perceptions of self-efficacy. A personalized feedback report outlines assessment results, highlights any problems or concerns related to cigarette use expressed by teen, and compares tobacco use levels with national norms for same age and gender peers.

    Behavioral: Motivational Intervention

  • Active comparator
    Relaxation Intervention

    The Relaxation Therapy intervention is a 60-90 minute individual session. The session encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and as a whole is really a meditation protocol.

    Behavioral: Relaxation Therapy

  • Experimental
    Cognitive Behavioral Therapy

    The Cognitive Behavioral Therapy (CBT) Intervention is administered during two 90 minute group sessions. The focus is 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.

    Behavioral: Cognitive Behavioral Therapy

  • Active comparator
    Self-Help Programming

    Self Help intervention is administered during two 90 minute group sessions. The intervention modules are 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.

    Behavioral: Self-Help Programming

Interventions

  • BehavioralMotivational Intervention

    The MI session will be 60-90 minutes in length.The focus is 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.A personalized feedback report outlines assessment results, highlights any problems or concerns related to cigarette use expressed by teen, and compares tobacco use levels with national norms for same age and gender peers.

    Also known as: Motivational Enhancement Therapy

  • BehavioralRelaxation Therapy

    The Relaxation Therapy intervention encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and meditation to reduce stress; which may lead to substance use.

  • BehavioralCognitive Behavioral Therapy

    The Cognitive-Behavioral Therapy (CBT) Intervention focuses on the interrelationship between thoughts, feelings, and behaviors. It addresses specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.

  • BehavioralSelf-Help Programming

    The Self-Help Programming intervention combines elements of Nicotine anonymous (NicA) to provide someone who uses nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. It incorporate the 12 Steps and the NicA "tools" (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine.

    Also known as: Nicotine Anonymous

06

What researchers measure

Primary outcomes

  1. Cigarette Use, Average # of Cigarettes Per Smoking Day.

    Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups

    Time frame: 6 months post release

  2. Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva

    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.

    Time frame: 6 months post release

  3. American Thoracic Society Questionnaire (ATSQ)

    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.

    Time frame: 6 months post release

  4. Percent Smoking Days

    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).

    Time frame: 6 months post release

07

Results

Posted Apr 20, 2020

Participant flow

Participant flow — Overall Study
MilestoneMotivational Intervention/Cognitive Behavioral TherapyMotivational Interviewing/Self-Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/Self-Help Programming
Started80687969
Completed75637565
Not completed5544
Withdrew: Lost to follow-up4423
Withdrew: Withdrawal by subject1120
Withdrew: Death0001

Outcome measures

PrimaryCigarette Use, Average # of Cigarettes Per Smoking Day.

Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups

Time frame:
6 months post release
Reported as:
Mean · days
Cigarette Use, Average # of Cigarettes Per Smoking Day.
daysMotivational Interviewing/ Cognitive Behavioral TherapyMotivational Interviewing/Self Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/Self Help Programming
Cigarette Use, Average # of Cigarettes Per Smoking Day.8.01 ± 6.528.87 ± 9.078.89 ± 7.297.55 ± 6.35
PrimaryNumber of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva

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.

Time frame:
6 months post release
Reported as:
Count of participants · Participants
Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva
ParticipantsMotivational Interviewing/ Cognitive Behavioral TherapyMotivational Interviewing/Self Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/Self Help Programming
Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva15151815
PrimaryAmerican Thoracic Society Questionnaire (ATSQ)

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.

Time frame:
6 months post release
Reported as:
Mean · score on a scale
American Thoracic Society Questionnaire (ATSQ)
score on a scaleMotivational Interviewing/ Cognitive Behavioral TherapyMotivational Interviewing/Self Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/Self Help Programming
American Thoracic Society Questionnaire (ATSQ)16.11 ± 6.3616.65 ± 6.8315.26 ± 6.6415.91 ± 6.53
PrimaryPercent Smoking Days

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).

Time frame:
6 months post release
Reported as:
Mean · percentage of smoking days
Percent Smoking Days
percentage of smoking daysMotivational Interviewing/ Cognitive Behavioral TherapyMotivational Interviewing/Self Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/Self Help Programming
Percent Smoking Days83.20 ± 32.5387.34 ± 24.6868.17 ± 38.7581.62 ± 33.22

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Motivational Intervention/Cognitive Behavioral Therapy0/80 (0%)0/80 (0%)0/80 (0%)
Motivational Interviewing/Self-Help Programming0/68 (0%)0/68 (0%)0/68 (0%)
Relaxation Intervention/Cognitive Behavioral Therapy0/79 (0%)0/79 (0%)0/79 (0%)
Relaxation Intervention/Self-Help Programming1/69 (1.4%)0/69 (0%)0/69 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Motivational Intervention/Cognitive Behavioral TherapyMotivational Intervention/Self-Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/ Self-Help ProgrammingTotal
Mean16.65 ± 1.0716.83 ± 1.0016.75 ± 1.1316.46 ± 1.2116.68 ± 1.11
Sex: Female, Male
Sex: Female, Male(Participants)Motivational Intervention/Cognitive Behavioral TherapyMotivational Intervention/Self-Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/ Self-Help ProgrammingTotal
Female168171152
Male64606258244
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Motivational Intervention/Cognitive Behavioral TherapyMotivational Intervention/Self-Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/ Self-Help ProgrammingTotal
Hispanic or Latino1826201680
Not Hispanic or Latino62425953216
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Motivational Intervention/Cognitive Behavioral TherapyMotivational Intervention/Self-Help ProgrammingRelaxation Intervention/Cognitive Behavioral TherapyRelaxation Intervention/ Self-Help ProgrammingTotal
American Indian or Alaska Native214310
Asian24017
Native Hawaiian or Other Pacific Islander01203
Black or African American2115131160
White55476054216
More than one race00000
Unknown or Not Reported00000
08

Study locations

1 site
  • Rhode Island Training School
    Cranston, Rhode Island 02920, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01387516
Lead sponsor
University of Rhode Island
Responsible party
Lynda Stein, Ph.D. (Professor, University of Rhode Island) — Principal investigator
First posted
Jul 4, 2011
Start date
Jul 2007
Primary completion
May 2014
Completion
May 2014
Results posted
Apr 20, 2020
Last update
Apr 30, 2025

Study contacts

Lynda Stein, Ph.D.
principal investigator · University of RI

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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