Motivation and Skills for Detained Teen Smokers
Condition: Motivational Intervention; Nicotine Anonymous; Cognitive Behavior Therapy; Relaxation Therapy
Study type: Interventional

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.
    

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.
    

Intervention name(s): Motivational Intervention; Relaxation Therapy; Cognitive Behavioral Therapy; Self-Help Programming
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.; 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.
Other intervention name(s): Motivational Enhancement Therapy; Nicotine Anonymous
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention 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 (Participant, Care Provider)
Primary purpose: Treatment
Keywords: nicotine; juveniles; detention