Motivation and Skills for Detained Teen Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lynda Stein, Ph.D., University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01387516
First received: May 25, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Motivational Intervention
Nicotine Anonymous
Cognitive Behavior Therapy
Relaxation Therapy
Behavioral: Motivational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Motivation and Skills for Detained Teen Smokers

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Smoking History & Patterns (SHP) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Smoking History and Patterns Questionnaire assesses cigarette and other tobacco use in the past, including the initial age when different smoking patterns began, and past quit attempt information.

  • Questionnaire of Smoking Urges-Brief [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This is a 10 item instrument with a 2-factor structure. It is a self report measure that is used to assess cravings and urges to smoke. Factor 1 is characterized by an anticipation of pleasure from smoking based on intention and desire to smoke. Factor 2 is negative affect with an urgent and overwhelming desire to smoke along with relief from nicotine withdrawal. A Likert scale from 1 (strongly disagree) to 7 (strongly agree) is used.

  • The Contemplation Ladder-Smoking [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The contemplation ladder lets participants self-report their intention to change their behavior on a continuum. Verbal anchors help participants assess their own level of readiness to change. For the current study the Contemplation Ladders are scaled from 0 to 10 and ask respondents to rate their readiness to change their smoking.

  • Modified Fagerström Tolerance (MFTQ) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This measure determines a respondent's smoking habits using a 4 point Likert scale on most items. It is also used to determine brand and type of cigarettes the teen smokes, and collects nicotine ratings.

  • Time Line Follow-back [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The TLFB is used to measure daily smoking at BL (30 days prior to detention) and each post-RD FU. A 30-day TLFB will be used during BL, a 60-day TLFB will be used for the 3- and 6- mo FUs.The TLFB data will be summarized to provide summary scores including total number of smoking days, average number of cigarettes smoked per day and per smoking day, percent of non-use days, maximum and minimum number of cigarettes per day, percent of use days, days to first cigarette, and longest number of days in a row used/did not use tobacco.

  • American Thoracic Society (ATSQ) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This measure assesses the frequency of experiencing respiratory symptoms.

  • Smoking Self-Efficacy (SSE) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This questionnaire is used to assess the temptation to smoke in different situations. It is comprised of 3 primary factors and 20 items: Positive affect/social situations, negative affect/situations, and habitual/craving situations.

  • CO levels-saliva cotinine tests [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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

  • 7-Day Point Prevalence [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The 7-day point prevalence assesses the amount the participant smoked each day for 7 days leading up to the baseline assessment.


Secondary Outcome Measures:
  • DISC-IV-Y [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The DISC is a diagnostic tool that is used in this study to urn randomize teens. For this study we focus on 4 areas, conduct disorder, major depressive disorder, post traumatic stress disorder and assesses 3 time frames: Past 4 weeks, past year, and lifetime.

  • Risks/Misbehaviors Questionnaire (RMBQ) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This is a 30 item assessment used to assess the number of times a teen was charged for misbehaviors in the past and for the current detention. It is based on empirical work by Dembo and colleagues and Elliot and colleagues.

  • Graduated Frequency of Alcohol Use [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This measure is used to assess the estimated volume of alcohol intake of a teen during the last 3 or 6 months. It asks respondents the largest amount of combined alcohol beverages (standard drinks) they have consumed in the past 3 or 6 months. It also assesses the frequency in consumption of all the lower quantity categories following the largest amount they drank in one single day.

  • Aggression Questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    This instrument is a 29-item self-reporting questionnaire used to measure different dimensions of hostility, anger and aggression. There are four subscales: Anger, (measures sense of control and anger related arousal), Hostility (measures feelings which highly undermine physical and psychological health), Verbal Aggression (measures the likelihood of being verbally argumentative), and Physical Aggression (measures the tendency of using physical force when expressing anger or aggression). Each item is rated on a 5 point Likert scale of 1 (Not at all Like Me) to 5 (Very Much Like Me).


Estimated Enrollment: 336
Study Start Date: July 2007
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Intervention Behavioral: Motivational 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.
Other Name: Motivational Enhancement Therapy
Active Comparator: Nicotine Annonymous Behavioral: Motivational 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.
Other Name: Motivational Enhancement Therapy

  Hide Detailed Description

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 RCT will use 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.

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 > 5 cigarettes a day 2) they have an estimated length of 4-7 weeks stay in detention. Special attention will be given to recruitment of girls and members of minority groups.

All teens who meet the inclusion criteria will be initially introduced to the study by RITS authorized personnel who will briefly explain the study. Teens will be approached in person at the facility. If the teen is interested in the study project staff will then approach the teen. All purposes and procedures will be fully described at that time, and all questions will be answered.It also will be 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,all teens will complete the baseline assessment protocol. This assessment will occur at the RITS and take 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.

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.Teens will be asked to sign a letter addressed to their locators that explains that they are participating in a research project at the 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.

Next, teens will be randomly assigned to MI/CBT or RT/ SHP. To optimize our chances of establishing a causal relationship between the treatment conditions and differential treatment outcome urn randomization will be employed (1). 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.Treatment providers will know the intervention condition assignment in advance.Research assistants will be blind to the intervention condition assignment throughout the study. The RT/SHP will be the experimental comparison condition. Teens in the MI/CBT condition will receive an individual session of MI, followed by two to three sessions of group CBT.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. 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 sessions will be 60-75 minutes in length.As stated previously, both the MI and CBT protocols proposed in this investigation have been used successfully in a number of projects involving adolescents.

Teens in the RT/SHP condition will receive one session of individual RT, followed by two to three sessions of SHP in a group format. The RT condition is designed to be comparable in time to the MI, thus participants in this condition will meet alone with a therapist for 60-90 minutes on one occasion. These sessions will focus on instruction in muscle relaxation and meditation, and teens 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 IRB approved intervention studies. SHP utilizes a Nicotine Anonymous (NiA) approach to group treatment. Therefore, the 12-step philosophy, tools and traditions of NiA, and what is gained by giving up nicotine are discussed along with tips for not smoking. Each of these 2-3 sessions will be 60-75 minutes in length.

A thirty minute assessment (FFU1) occurs after the individual MI or RT session. A 45 minute session occurs at the end of a teen's last group session (FFU2). These assessments are conducted by an RA blind to treatment assignment.This assessment taps retention of experimental treatment effects.Incentives include snacks and individual attention.

A research assistant will schedule a post-release three month FU prior to the teen'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 FU, at six months post release, will be scheduled by the RA conducting the previous session. All FU assessments will be 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 who is blind to treatment assignment. 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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 13-19 years old,
  • daily cigarette smoker,
  • in facility for at least 4 days.

Exclusion Criteria:

  • non-smoker,
  • not in facility long enough (i.e. 4 days).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387516

Locations
United States, Rhode Island
Rhode Island Training School
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
University of Rhode Island
Investigators
Principal Investigator: Lynda Stein, Ph.D. University of RI
  More Information

Additional Information:
No publications provided

Responsible Party: Lynda Stein, Ph.D., Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01387516     History of Changes
Other Study ID Numbers: R01DA20731
Study First Received: May 25, 2011
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
nicotine
juveniles
detention

ClinicalTrials.gov processed this record on July 29, 2014