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Motivational InterventionNCT01387516

Motivation and Skills for Detained Teen Smokers

A study testing Motivational Intervention, Relaxation Therapy and Cognitive Behavioral Therapy in people with Motivational Intervention and Nicotine Anonymous, run by University of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
What is being tested?
Motivational Intervention, Relaxation Therapy and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
1 siteUnited States
Study dates
Jul 2007to May 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rhode Island Training School

    Cranston, Rhode Island, 02920

Other trials in United States

About this study

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.

Being tested
Motivational Intervention, Relaxation Therapy, Cognitive Behavioral Therapy, Self-Help Programming
Keywords
nicotine, juveniles, detention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational InterventionBehavioural

    Also called Motivational Enhancement Therapy

    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.

  • Relaxation TherapyBehavioural

    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.

  • Cognitive Behavioral TherapyBehavioural

    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.

  • Self-Help ProgrammingBehavioural

    Also called Nicotine Anonymous

    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.

Study groups in NCT01387516
Study groupRoleWhat they receive
Motivational InterventionExperimentalMotivational 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.
Receives: Behavioral: Motivational Intervention
Relaxation InterventionActive comparatorThe 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.
Receives: Behavioral: Relaxation Therapy
Cognitive Behavioral TherapyExperimentalThe 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.
Receives: Behavioral: Cognitive Behavioral Therapy
Self-Help ProgrammingActive comparatorSelf 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.
Receives: Behavioral: Self-Help Programming

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 6 months post release

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2011 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
This clinical trial uses a 2 x 2 between groups factorial design to investigate Motivational Interviewing versus Relaxation Therapy and Cognitive Behavior Therapy versus Self-Help Programming.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01387516
Sponsor's protocol ID
R01DA020731
Status last verified
Apr 2025
First submitted
25 May 2011
Last updated
30 Apr 2025
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Intervention, Relaxation Therapy and Cognitive Behavioral Therapy in people with Motivational Intervention and Nicotine Anonymous, run by University of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cigarette Use, Average # of Cigarettes Per Smoking Day. (time frame: 6 months post release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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