Randomized Controlled Trial of a Webbased Youth Smoking Intervention

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Randomized Controlled Trial of a Web-based Youth
Smoking Intervention

• Oonagh Maley, Cameron Norman Harvey Skinner
• Department of Public Health Sciences
• University of Toronto

FUNDED BY
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Learning Objectives

• Describe key elements for effective engagement of
  adolescents using a web-based smoking cessation
  and prevention intervention
• Identify strategies for implementing a web-based
  randomized control study in a school setting
• Recognize challenges inherent in conducting
  smoking cessation research in schools and using
  web-based resources

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Presentation Overview

• Introduce the Smoking Zine website
• Examine challenges of working with youth about
  tobacco
• Highlight innovative opportunities of eHealth for
  tobacco control
• Provide an overview of the TeenNet Project
• Describe the randomized trial initial results
• Review Lessons Learned

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The Smoking Zine
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Tobacco Youth Challenges and Opportunities

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The High Cost of Smoking

• The lifetime medical costs of cigarette smokers
  are approximately 1/3 higher than non-smokers
• Harvard Report (1996) concluded that nearly
  two-thirds of cancer deaths (US) are linked to
  preventable risk behaviors
•       30 smoking  
•       30 adult diet and obesity
• 5 physical activity level
• Law and Tang (1995) estimate a cost of 1,500
  (US) for saving a life through routine 5-minute
  advice to all smokers to stop
• Few procedures in medicine carry so small a cost
  of saving a life

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Tobaccos Impact on Children Youth

• Direct Effects 250 million children alive today
  will be killed by tobacco in the future if
  current consumption patterns continue
• Indirect Effects Nearly 700 million children
  (almost half worlds population) breath air
  polluted by second hand smoke
• World Health Organization (2001). Tobacco and the
  Rights of the Child. Geneva.

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Smoking Initiation in Canada

• Begin - 8 years
• Increase 11 years
• Peak 16 years
• Smoke free at 19 years Little chance of ever
  starting

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Stages of Change of Canadian Smokers
Source CTUMS, 2001
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The Challenge is Large.but not Insurmountable
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Why the Internet?
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Youth Online

• United States 73 of youth online, 57 of
  general population using the Internet for health
  information1
• Canada 99 of youth online, 52 have used the
  Internet for health information2
• 1 PEW Internet American Life Project (2001)
• 2 Environics / Media Awareness (2001)

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Key Reasons for Using the Internet for Youth
Tobacco Control

• Reaches youth where they are
• Interventions are not bound by time or space
• Interactivity and active learning media
  combinations
• Potential for tailoring to users
• Easy to update and modify
• Minimal cost for maximum reach
• Because the tobacco industry is already there!

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Designing Effective Interventions

• Accessible
• Individualized
• Remote (e.g.,telephone) Group Counselling
• Provide opportunities for assisted self-help
• Strengthen social support networks
• Use biomarker feedback
• Must be efficient ( realistic)
• Population X Reach X Efficacy
• See Niaura Abrams, 2002

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The TeenNet Project
Based at Department of Public Health
Sciences Faculty of Medicine University of
Toronto Toronto, Ontario Canada
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TeenNet Research Project

• Established in 1995
• Lead by Dr. Harvey Skinner
• Based in the Department of Public Health Sciences
  in the Faculty of Medicine, University of Toronto
• http//www.teennetproject.org

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TeenNet Project Goals

• Generate new knowledge and practical tools for
  engaging youth in health promotion
• Evaluate innovative models for using Interactive
  Communication Technology for health promotion
• Collaborate for research and capacity building
  locally, nationally and internationally
• Disseminate best practices and models for
  knowledge translation and sustainability .

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TeenNets Guiding Principles

• Participatory
• Relevant to Youth
• Autonomy Supporting
• Active Learning and Fun
• Accessible
• Youth in Action Approach

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Youth in Action Approach

• Initial needs identification
• Focus groups with youth
• Brain storming sessions with youth
• Concept development and assessment
• Youth working groups
• Youth forums
• Reality checks with youth
• Professional advisors and/or advisory groups
• Prototype development and assessment
• Youth employees
• Reality checks with youth and practitioners
• Quality review committee (for website links)
• Ongoing feedback through website and discussion
  boards

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TeenNet Research Projects

• Adolescent Gambling
• Community Capacity
• Global Youth Voices
• Positive Youth Project
• Smoking Zine Evaluation
• Youth, Technology and Access

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Diverse Youth
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Randomized Controlled Trial Overview

• Principal Investigator Harvey Skinner
• Co-Investigators Eudice Goldberg
• Cameron Norman
• Program Manager Oonagh Maley

Funded by
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What was this study?

• Population Adolescents (grades 9-11)
• Issue Smoking eHealth Literacy
• Program Web Face-to-face
• Setting School
• Desired Effect Population impact

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Community Partners

• Toronto Public Health (Tobacco Team)
• YMCA Youth Substance Abuse Program, Toronto

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The Team

• Team Leaders
• Oonagh Maley, MISt
• Cameron Norman, MA
• Public Health Nurses
• Mary-Anne McBean
• Sue St John
• Sarah Newham
• Voula Varsamidou
• Youth Counsellors Research Assistants
• Lisa Ennis, MSW--RSW
• Celeste Le Duigou, MSW--RSW
• Jennifer Moses, MSW
• Jennifer Reynolds, MEd
• Bohdan Turok, MEd CCC, CHt

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TeenNet Support

• Sherry Biscope, MHSc
• Shawn Chirrey, MHSc
• Jennifer Elliott
• Sarah Flicker, MPH
• Vero Michelli
• Meg Morrison, MEd
• Mabel Soo

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Initial Research

• Spring 2000 Instrument Development
• Summer-Fall 2000 Community-based trial
• Winter-Spring 2001 Instrument re-development
• Summer 2002 Community-based pilot tests
• 1995-2003
• Ongoing reality checks
• Test groups

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Study Design
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Study Overview

• A two-group randomized trial
• Major Research Questions
• Does the Smoking Zine Intervention promote
  behaviour change in youth smokers?
• Does the Smoking Zine enhance resistance to
  smoking among non-smokers?
• Does exposing adolescents to critical appraisal
  tools assist them in building e-Health
  literacy?

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Study Timeline (Administrative)

• 2000 Focused partnership with local Public
  Health Department develops
• 2001 Consultations with School Administrators
  curriculum consultants
• 2001 Collaboration with YMCA-YSAP
• 2001-2 Relationship building with individual
  schools
• 2002 Active Passive Consent Process

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Study Overview

• 1. Smoking Zine Website Intervention including
  motivational counseling, virtual group support,
  feedback
• 2. Control Condition website evaluation task
• Measures Pre Post intervention, 3 6 month
  follow-up
• a) Resistance to Smoking
• b) Intentions to Smoke
• c) Smoking Behavior
• Initial Results
• School by Grade by Sex by Smoking Status
  interaction
• e.g. decreased tobacco use for grade 9 boys

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Study Procedures

• Complete baseline instruments
• Zine or Web Evaluation (Control) Task with
  booklet in class
• 10-minute MI Group with booklet
• Complete Post-test measures
• CO Monitor
• Tailored email messages between follow-ups
• Complete follow-up assessments (3 6 mo.)

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The Interventions
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Intervention

• Intervention The Smoking Zine including access
  to online discussion forum for peer support and
  mutual aid
• Control Modified website evaluation checklist
  applied to three non-health websites
• Group-based motivational interview
• Booklet
• Follow-up tailored emails

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Intervention Smoking Zine
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The Smoking Zine

• Launched May 2000
• Based on multiple theoretical approaches
• Youth empowerment Harm Reduction approach to
  tobacco use
• Youth in Action approach to development and
  evaluation
• Multilingual (English, French, Chinese)

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The Smoking Zine

• Five stages
• Self-assessments, games, discussion forum,
  personalized quit plans
• Builds motivation through
• Building on readiness for change
• Enhancing self-efficacy
• Fostering self-determination
• Connecting with community/peers
• Identifying discrepancies between goals and
  behaviour
• Personal forecasting

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Linking Theory Evidence

• Health Behaviour Models (individual level)
• Self-Determination Theory
• Social Cognitive Theory (Self-Efficacy)
• Transtheoretical Model (Readiness for Change)
• Motivational Interviewing (Decision Balance)
• Theory of Reasoned Action Planned Behavior
• Health Belief Model
• Multisystems - multilevel integration
• Health Promotion five coordinated actions
• (1986 WHO Ottawa Charter)
• Community Capacity Building and Mobilization

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Meet the Smoking Zine
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Control Condition Website Evaluation
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Control Condition Web Evaluation
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Control Task Website Evaluation

• Developed with youth health consumers
• Includes both professional and
  consumer-oriented criteria
• Focus on both knowledge and skill development

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Booklets
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Smoking Zine Booklet

• Created to allow youth to record results from the
  Zine without printing
• Wallet card with login information
• Used in MI discussions
• May be taken home and re-used as needed

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Smoking Zine Booklet
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CyberHealthLiteracy Booklet

• Created to allow youth to review websites and
  calculate a rating based on five criteria
• Wallet card with cyberliteracy url
• Used in MI discussions
• May be taken home and re-used as needed

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Booklet Web Evaluation
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Motivational Interview
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Motivational Interviewing

• An approach to fostering change through
  enhancement of a clients readiness and intrinsic
  motivation
• Motivational interviewing is a client-centred,
  directive method for enhancing intrinsic
  motivation to change by exploring and resolving
  ambivalence (Miller Rollnick, 2002)

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Motivational Interviewing Adaptation for Group
Setting

• Uses a single-session model
• Brief format (10 minutes in duration)
• Few known attempts at adapting to group form no
  known outcome studies
• No single-session group models
• Focus on the Decision Balance (pros and cons) and
  exploring ambivalence about change

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Sample Discussion Questions
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Randomized Controlled TrialOutcome Measures
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Measurement Points
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Smoker Definition (Mills et al., 1994)

• Q1 Which of the following statements best
  describes your use of tobacco in your lifetime?
•  
• Q2 During the past 30 days, on how many days did
  you smoke cigarettes?

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Lifestyle Technology Profile

• 30-item questionnaire on
• Risk behaviors
• e.g., Substance use, diet exercise
• Technology use
• e.g., email, World Wide Web, Wireless phones
• Demographics
• e.g., age, grade, cultural affiliation

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Measures of ChangeLikelihood of Action Scale
eHEALS

• 23-item scale based on the five major behavior
  change theories used to guide the Smoking Zine
  (Skinner, 2002)
• Pilot tested with youth in community, school and
  clinical settings over 3 years
• Scale items obtained through tobacco survey
  databases, published scales and partnership with
  other researchers in the area of adolescent
  health
• eHEALS eHealth Literacy Scale

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Likelihood of Action Index
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Data Collection
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Follow-up
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Follow-up

• Response Rates
• 89 (3-months) 87 (6-months)
• Participants complete survey in class
• 25 randomly chosen to complete CO monitoring
  not at 6-month due to SARS outbreak
• Tailored email support follows until 6-months
• Participants complete survey in class
• All participants are informed of the Zine and Web
  Evaluation resources

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CO Monitoring

• Validates smoking self-report
• Potential for bogus pipeline
• Opportunity to engage youth and reinforce the
  message

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Data Analysis and Results
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Study Demographics

• N1410
• 760 Boys
• 650 Girls
• 214 smokers at baseline (15 of total)
• 14 urban high schools Public Catholic
  districts
• 83 classes
• Grades 9-11
• Passive and Active Parental Consent
• Active Youth Consent

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Key Findings

• Smoking Zines greatest potential impact with
• Grade 9 students (cessation and prevention)
• Boys
• Smokers (Zine as treatment)
• High-risk schools
• eHealth Literacy
• Main effect
• ? Small intervention effect with great potential
  cumulative effect on a population level

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Planned Analysis Results

• I. Psychometric Assessment
• Item (reliability) analysis
• Confirmatory factor analysis
• II. Impact Assessment
• Doubly-repeated Measures MANOVA (SPSS v11.5)
• Structural Equation Modeling (Mplus, v2.14)
• Hierarchical Linear Modeling (MLwiN v1.1)

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AnalysisThree Approaches

• MANOVA Multivariate Analysis of Variance
• Intervention X Smoker X Grade X Sex interaction
• HLM Hierarchical Linear Modeling
• School and Grade level effects
• Multiple Rs ranging from .88 (post) to .40
  (6-month)
• SEM Structural Equation Modeling
• I. Measurement model three factor (latent
  variables)
• II. Path Model

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Outcome Measures

• Three Key Scales
• Resistance to smoking
• Intentions to smoke
• Cigarette consumption
• Smoking Status
• Satisfaction with Intervention

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Cigarette Use Scale
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Behavioral Intention Scale
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Resistance to Smoking Scale
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Study Impact

• Interaction effects indicate strongest effect
  for grade 9s for both prevention and cessation
• Most noticeable effects with smokers (cessation)

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Smoking Cessation
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Resistance to Smoking (p lt .05)

• Grade
• Grade by Sex
• Most noticeable influence on grade 9 boys

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Behavior Intention (p lt .05)

• Grade
• Group by Grade
• Group by Smoker by Grade
• Group by Smoker by Grade by Sex
• Smoker by Grade by Sex
• Most noticeable influence on smokers (boys)
  in grade 9

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Cigarette Use (p lt .05)

• Grade
• Group by Smoker by Sex
• Grade by Sex
• Smoker by Grade
• Smoker by Grade by Sex
• Most noticeable influence on smokers (boys)
  in grade 9

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Key Findings

• Smoking Zines greatest potential impact with
• Grade 9 students (cessation and prevention)
• Boys
• Smokers (Zine as treatment)
• High-risk schools
• eHealth Literacy
• Main effect
• ? Small intervention effect with great potential
  cumulative effect on a population level

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Multi-level Modelling
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In Progress Multi-level Model
Supra-level
Context School, Grade, Class
Individual Sex, Smoker, Intervention
Base Level
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Preliminary findings

• Significant effect for Grade 9 students for both
  smoking cessation and prevention of smoking
  acting on behavior intention
• Effect most noticeable with boys
• No class effects

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Lessons Learned

• Study Process - Web-based Interventions
• The Team - Working with Schools
• Working with Youth

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Lessons Learned 1 Study Process

• Pilot..pilot..pilot
• Build solid community partnerships
• Communicate with your partners
• Hire administrative support
• Debrief and improve process
• Things always take longer!
• No two days are alike

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Lessons Learned 2 The Team

• Identify a clear chain of command
• Hire staff to complement each other
• Ensure a range of experience with youth
• Select staff with leadership skills
• Cross train staff on all study roles
• Have back-up staff available and trained

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Lessons Learned 3 Web-based Interventions

• Youth and adult testing
• Onsite technology assessments
• Quality of access is an issue
• Literacy is an issue
• ESL and Special needs are an issue
• On-call technical support is critical
• Establish back-up procedures in advance
• Upfront development costs extensive

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Lessons Learned 4 Working With Schools

• Create partnerships early
• Persistence is key
• Consult with educators administrators
• Reflect school realities in your study
• Outline school roles and responsibilities
• Provide value to schools, teachers students

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Lessons Learned 4 Working With Schools

• Identify fit with existing activities
  curriculum
• School level compensation
• Identify and support a champion
• Provide ongoing feedback
• Changing routine is difficult
• Dont assume support structures

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Lessons Learned 5 Working With Youth

• Communicate with respect
• Provide clear concise instructions
• They are interested in research
• Get back to them with results
• Grade 9 is not Grade 10 is not Grade 11

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Future Directions
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Next Steps

• Follow-up studies examining the interaction
  effects
• Boys, Lower grades, High-Risk Schools
• Whole-school approach (including parents and
  community)
• Smoking Zine in primary care settings
• International Applications
• China
• Brazil
• Middle East

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Take Home Message
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Take Home Messages

• Ensure authentic youth involvement in all
  phasesdesign,implementation,evaluation
• Pilot test the intervention in stages (iterative
  development)
• Build partnerships that respect and recognize
  their needs and challenges

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Designing Effective Interventions

• Accessible
• Individualized
• Remote Group Counselling
• Provide opportunities for assisted self-help
• Strengthen social support networks
• Use biomarker feedback
• Must be efficient ( realistic)
• Population X Reach X Efficacy

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Thank you ?
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Contact Us

• Oonagh Maley
• oonagh.maley_at_utoronto.ca
• 416.978.7543
• Cameron Norman
• cameron.norman_at_utoronto.ca
• 416.209.6740