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Motivation and Skills for Detained Teen Smokers

This study has been completed.
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: June 2, 2017
Last verified: June 2017
  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 Behavioral: Relaxation Therapy Behavioral: Cognitive Behavioral Therapy Behavioral: Self-Help Programming

Study Type: Interventional
Study Design: 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
Official Title: Motivation and Skills for Detained Teen Smokers

Resource links provided by NLM:


Further study details as provided by Lynda Stein, Ph.D., University of Rhode Island:

Primary Outcome Measures:
  • Smoking History & Patterns (SHP) [ Time Frame: Day 1 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    This measure assesses the frequency of experiencing respiratory symptoms.

  • Smoking Self-Efficacy (SSE) [ Time Frame: Day 1 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).


Enrollment: 314
Actual Study Start Date: July 2007
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Intervention
Motivational 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.
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: Relaxation Intervention
The 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.
Behavioral: Relaxation Therapy
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.
Experimental: Cognitive Behavioral Therapy
The 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.
Behavioral: Cognitive Behavioral Therapy
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.
Active Comparator: Self-Help Programming
Self 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.
Behavioral: Self-Help Programming
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 Name: Nicotine Anonymous

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 13-19 years old,
  • smokes average of 1 cigarette or cigarillo per day
  • 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:
Responsible Party: Lynda Stein, Ph.D., Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01387516     History of Changes
Other Study ID Numbers: R01DA020731 ( U.S. NIH Grant/Contract )
Study First Received: May 25, 2011
Last Updated: June 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lynda Stein, Ph.D., University of Rhode Island:
nicotine
juveniles
detention

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017