randomized controlled trial of a web-based youth smoking intervention oonagh maley, cameron norman...

Randomized Controlled Trial of a

Web-based Youth Smoking Intervention

Oonagh Maley, Cameron Norman & Harvey SkinnerDepartment of Public Health Sciences

University of Toronto

FUNDED BY:

December 10, 2003NCTH Boston, MA

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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 Lesson’s Learned


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The Smoking Zine

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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Tobacco’s 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 world’s 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

Age of Initiation to Smoking

Source: FNIRHS, 1997. (FNIRHS data based on population expansion weighted proportion)

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Age

0

1

2

3

4

5

6

7

% s

tart

ing

Female Male


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Stages of Change of Canadian Smokers

19

28 27

2117

20

3034

22

149

25

1511

5 3

41

4

49

13

19

42

62

0

10

20

30

40

50

60

Precontemplation Contemplation Preparation Action Maintenance

ALL 15-19 20-24 25-44 45+

Source: CTUMS, 2001


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The Challenge is Large….but not Insurmountable

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

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 1995Lead by Dr. Harvey SkinnerBased 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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TechnologyOptions

Dissemination

Utilization

RapidPrototyping

Feasibility

Do

Ownership

Community Capacity

Engagement

Relevance

Study

Plan

Listen/Dialogue

DevelopmentCycles

CommunityInvolvement

TeenNet Action Research Model

Act


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TeenNet’s 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 LiteracyProgram: Web & Face-to-face Setting: SchoolDesired 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, MHScShawn Chirrey, MHScJennifer Elliott Sarah Flicker, MPHVero MichelliMeg Morrison, MEdMabel 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

Zine vs.Control?

Lifestyle &Technology

ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END

3-months 6-months45-minutes

MotivationalInterview



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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-YSAP2001-2: Relationship building with

individual schools2002: 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 ResultsSchool by Grade by Sex by Smoking Status interaction

e.g. decreased tobacco use for grade 9 boys


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Study Procedures

1. Complete baseline instruments

2. Zine or Web Evaluation (Control) Task with booklet in class

3. 10-minute MI Group with booklet

4. Complete Post-test measures

5. CO Monitor

6. Tailored email messages between follow-ups

7. Complete follow-up assessments (3 & 6 mo.)

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

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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The Smoking Zine

Launched May 2000Based on multiple theoretical

approachesYouth empowerment & Harm Reduction

approach to tobacco use‘Youth in Action” approach to

development and evaluationMultilingual (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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Self - Determination Theory Deci and Ryan (1985)

Motivated BehaviorAutonomous Controlled

self determined pressured

"want to do it"

"should do""have to"


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Maintenance

Action

Preparation

Contemplation

Precontemplation

Processes of Change

Relapse Prevention

Motivational Interviewing

BehavioralCognitive/Experiential

Build Motivation Strengthen Commitment


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Readiness For Change

DecidedNot ToChange

Not ThinkingAboutChange

Soon, Next30 Days

Now

NOTREADY UNSURE READY

1 2 3 4 5

Undecided

Skinner (2002)

Meet the Smoking Zine


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Control Condition: Website Evaluation

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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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

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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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

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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Motivational Interviewing

An approach to fostering change through enhancement of a client’s 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

Smoking Zine (Smoker)Group:

Smoking Zine (Non-Smoker)Group:

What were your reasons for changing your smoking behaviour?

What were some of your reasons not to change?

How did your scores balance out?

How can this information help you make decisions about what to do next?

What were your reasons for being smoke free?

What concerns do you have about remaining smoke-free?

How did your scores balance out?

How can this information help you make decisions about what to do next?

Randomized Controlled Trial:Outcome Measures


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Measurement Points

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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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 & exerciseTechnology use

e.g., email, World Wide Web, Wireless phonesDemographics

e.g., age, grade, cultural affiliation


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Measures of Change:Likelihood 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

Likelihood ofAction Index

TranstheoreticalModel

Theory ofReasoned Action

/ PlannedBehaviour

Social CognitiveTheory

Self-Determination

Theory

Health BeliefModel


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Data Collection

Measures Baseline Post Test 3 Month 6 Month

1. Resistance

to InitiationX X X X

2. Behavioral

IntentionX X X X

3. Smoking

BehaviorX X X


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Follow-up

Zine vs.Control?


ProfilePretest

WebsiteEvaluation

SmokingZine

Post-test3-month

Follow-up6-month

Follow-up

END





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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

Data Analysis and Results


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Study Demographics

N=1410 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 Zine’s 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) analysisConfirmatory factor analysis

II. Impact AssessmentDoubly-repeated Measures MANOVA

(SPSS v11.5)Structural Equation Modeling (Mplus, v2.14)Hierarchical Linear Modeling (MLwiN v1.1)


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Analysis:Three 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 smokeCigarette consumption

Smoking StatusSatisfaction with Intervention


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Cigarette Use ScaleItem Item-Scale

Correlation

1. . Cigarette Use: Lifetime .75

2. Cigarette Use: Past 30 Days .83

3. Cigarette Use: Daily .78

Internal Consistency Reliability (alpha)

.85


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Behavioral Intention Scale

Item Item-Scale Correlation

1. Intent to smoke: I year .83

2. Intent to smoke: 6-months .84

3. Intent to smoke: 30-days .59

Internal Consistency Reliability (alpha)

.82


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Resistance to Smoking Scale

Item Item-Scale Correlation

1. Affect .54

2. Efficacy .77

3. Willingness .70

4. Decision Balance .41

5. Self Determination .52

6. Importance .63

7. Readiness to Change .64

Internal Consistency Reliability (alpha) .83

Resistanceto Smoking

Affect

Self-efficacy

Self-Determination

DecisionBalance

Readiness

Willingness

BehaviouralIntention

Cigarette Use

Intent(6 months)

Intent(3 months)

Intent(daily)

Importance

Lifetime

Last 30 Days

Daily

E6

E1

E2

E3

E7

E5

E4

E13

E12

E11

E10

E9

E8

Study Impact

Interaction effects indicate strongest effect for grade 9’s for both prevention and cessation

Most noticeable effects with smokers (cessation)

Smoking Cessation


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Resistance to Smoking (p < .05)

Grade Grade by Sex

* Most noticeable influence on grade 9 boys


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Behavior Intention (p < .05)

Grade Group by GradeGroup by Smoker by Grade Group by Smoker by Grade by SexSmoker by Grade by Sex

* Most noticeable influence on smokers (boys) in grade 9


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Cigarette Use (p < .05)

GradeGroup by Smoker by Sex Grade by SexSmoker by GradeSmoker by Grade by Sex

* Most noticeable influence on smokers (boys) in grade 9


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Key Findings

Smoking Zine’s 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

Base Level

Context:

School, Grade, Class

Individual:

Sex, Smoker, Intervention


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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 boysNo class effects

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 partnershipsCommunicate with your partnersHire administrative supportDebrief and improve processThings always take longer!No two days are alike


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Lessons Learned 2: The Team

Identify a clear chain of commandHire staff to complement each otherEnsure a range of experience with youth Select staff with leadership skillsCross train staff on all study rolesHave 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 earlyPersistence is keyConsult with educators & administratorsReflect school realities in your studyOutline school roles and responsibilitiesProvide value to schools, teachers &

students


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Lessons Learned 4: Working With Schools

Identify fit with existing activities & curriculum

School level compensationIdentify and support a championProvide ongoing feedback Changing routine is difficultDon’t assume support structures


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Lessons Learned 5: Working With Youth

Communicate with respectProvide clear concise instructionsThey are interested in researchGet back to them with resultsGrade 9 is not Grade 10 is not Grade 11

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

Take Home Message


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Take Home Messages

Ensure authentic youth involvement in all phases:design,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

Thank you


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Contact Us

Oonagh Maley

[email protected]

416.978.7543

Cameron Norman

[email protected]

416.209.6740

randomized controlled trial of a web-based youth smoking intervention oonagh maley, cameron norman...

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