Motivation and Skills for Detained Teen Smokers
|ClinicalTrials.gov Identifier: NCT01387516|
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : June 5, 2017
|First Submitted Date ICMJE||May 25, 2011|
|First Posted Date ICMJE||July 4, 2011|
|Last Update Posted Date||June 5, 2017|
|Actual Study Start Date ICMJE||July 2007|
|Actual Primary Completion Date||May 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 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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||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
|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||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||May 2014|
|Actual Primary Completion Date||May 2014 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||13 Years to 19 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01387516|
|Other Study ID Numbers ICMJE||R01DA020731( U.S. NIH Grant/Contract )|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||Lynda Stein, Ph.D., University of Rhode Island|
|Study Sponsor ICMJE||University of Rhode Island|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of Rhode Island|
|Verification Date||June 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP