NCT01387516

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6 years until next milestone

Results Posted

Study results publicly available

April 20, 2020

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

May 25, 2011

Results QC Date

October 18, 2018

Last Update Submit

April 14, 2025

Conditions

Keywords

nicotinejuvenilesdetention

Outcome Measures

Primary Outcomes (4)

  • Cigarette Use, Average # of Cigarettes Per Smoking Day.

    Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups

    6 months post release

  • Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva

    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. These levels will determine if the participant is verified as being abstinent from smoking during the week before collection.

    6 months post release

  • American Thoracic Society Questionnaire (ATSQ)

    This validated 8 item measure assesses the frequency of experiencing several respiratory symptoms using a 5 point Likert scale from 1, never to 5, every day. The minimum score is 8 indicating no experience of respiratory symptoms and the maximum score is 40 which indicates a high frequency of experiencing respiratory symptoms.

    6 months post release

  • Percent Smoking Days

    Using a Time-Line Follow-back, we calculated percent smoking days for a 60 day period at 6-month follow-up. This is the percentage of smoking days a participant had out of possible smoking days (days for which the participant was not in a controlled environment where they did not have access to cigarettes).

    6 months post release

Study Arms (4)

Motivational Intervention

EXPERIMENTAL

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

Relaxation Intervention

ACTIVE COMPARATOR

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

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Self-Help Programming

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Motivational Enhancement Therapy
Motivational Intervention

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.

Relaxation Intervention

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.

Cognitive Behavioral Therapy

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.

Also known as: Nicotine Anonymous
Self-Help Programming

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old,
  • smokes average of 1 cigarette or cigarillo per day
  • in facility for at least 4 days.

You may not qualify if:

  • non-smoker,
  • not in facility long enough (i.e. 4 days).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Training School

Cranston, Rhode Island, 02920, United States

Location

MeSH Terms

Interventions

Motivational InterviewingRelaxation TherapyCognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapy

Results Point of Contact

Title
Dr. Lynda Stein, Ph.D.
Organization
University of Rhode Island

Study Officials

  • Lynda Stein, Ph.D.

    University of RI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2011

First Posted

July 4, 2011

Study Start

July 1, 2007

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 30, 2025

Results First Posted

April 20, 2020

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations