Motivation and Skills for Detained Teen Smokers
|First Received Date ICMJE||May 25, 2011|
|Last Updated Date||March 20, 2014|
|Start Date ICMJE||July 2007|
|Estimated Primary Completion Date||June 2014 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01387516 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Motivation and Skills for Detained Teen Smokers|
|Official Title ICMJE||Motivation and Skills for Detained Teen Smokers|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Intervention ICMJE||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
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||336|
|Estimated Completion Date||August 2014|
|Estimated Primary Completion Date||June 2014 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||13 Years to 19 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01387516|
|Other Study ID Numbers ICMJE||R01DA20731|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Lynda Stein, Ph.D., University of Rhode Island|
|Study Sponsor ICMJE||University of Rhode Island|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Rhode Island|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP