Cognitive and Emotional Skills to Aid Smoking Prevention

Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:12 - 16
Start Date:October 2016
End Date:March 2019
Contact:Eugenia I Gorlin, Ph.D.

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Rescuing Cognitive and Emotional Regulatory Processes to Aid Smoking Prevention

The purpose of the current proposal is to investigate the extent to which interventions
designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory
processes enhance the effectiveness of standard no-smoking informational interventions.
Emotional and cognitive dysregulation increases the likelihood of smoking and makes it
particularly challenging to benefit from standard interventions. Working memory and
associated deficits make it more difficult for individuals to utilize information from
interventions, make judicious decisions regarding the cost and benefits of smoking, and to
resist targeted advertising. In addition, disruptions in emotion regulatory capacities
increase the probability of using cigarettes as a coping mechanism to self-regulate negative
affect and stress. Individuals with affective disturbances smoke at higher rates and have
more difficulties quitting, and are more likely to smoke as a way to reduce negative affect.
The goal of the current project is to generate new insights and new approaches to smoking
prevention among low-SES youth by investigating (1) the influence of known SES-related
deficits in working memory and affect regulation on proximal measures of smoking risk, and
(2) the potential for targeted interventions to reverse these risks. Specifically, the
investigators examine the influence of working memory training and distress tolerance
(mindfulness) interventions on cognitive/affective targets placing individuals at risk for
smoking initiation and maintenance.

The specific aims of this study are therefore to investigate:

1. The feasibility and acceptability of school- and community-based brief interventions
targeting working memory and distress tolerance in a diverse sample of low SES

2. The effects of working memory and distress tolerance interventions, relative to a
standard informational intervention alone, on specific cognitive-affective targets—delay
discounting and distress tolerance--relevant to cigarette smoking initiation and

3. The impact of cognitive /affective target activation on proximal measures of smoking
risk/behavior and related health outcomes following intervention.

Overview. The investigators are targeting a high-risk (low SES adolescents) population at a
highly relevant period (high school) for smoking onset. The study design calls for block
randomization of 150 non-smoking adolescents to one of three intervention conditions: (1) a
control condition offering health education combined with a smoking prevention informational
intervention (C+SPII), (2) a Working Memory intervention delivered prior to a smoking
prevention informational intervention (WM+SPII), (3) a Distress Tolerance Intervention
delivered prior to a smoking prevention informational intervention (DT+SPII). Smoking risk
proximal outcomes are assessed by smoking propensity self-report, delay discounting, and
implicit associations to smoking; smoking behavior is assessed at one-month follow-up.

Research material will consist of participant self-report of smoking, peer smoking, and
parental smoking as well as self-report of personality characteristics (e.g. sensation
seeking) that are associated with risk behaviors. Biological data (from exhalations) is also
sampled for analysis of CO, to confirm non-smoking status.

Location of Interventions:

At this writing, the investigators are awaiting funding confirmation to decide among three
options for how we will provide the interventions at the high school. The investigators have
thought through and planned for the following three possibilities: (1) a school-time
intervention in selected classroom space specific to the randomized intervention, (2) an
afterschool intervention in open classroom space, and (3) an afterschool intervention in a
community center. The investigators prefer these options in descending order (1 to 3), but
final negotiation of space is pending their ability to confirm with the sites that the
investigators will indeed do the project (have obtained funding). For example, as noted in
the application, "the headmaster of Fenway High School, Peggy Kemp, is extremely supportive
of our work, and plans to provide both institutional and social support in our endeavor." In
the investigators' meetings with her, she suggested that the investigators try to provide the
intervention during the school week; noting that these interventions fit the instructional
demands for either the home room or PE time. Use of these in-school instructional slots would
require approval of the school superintendent, but the process of obtaining such approval
necessarily awaits confirmation of funding. The letters of support the investigators have
obtained documents that if they are unable to realize option #1 or option #2, they can still
realize this project demands by utilizing option #3.

Interventions: Participants will be randomized (using a random number table utilizing
variable block sizes) to 1 of 3 study conditions according to two block randomization
factors: sex and parental smoking status. Each intervention is to be delivered over eight
consecutive weeks. Interventions are to be led by the Project Director, Dr. Eugenia Gorlin,
with ongoing supervision from Drs. Otto and Doan. All interventions will be delivered in
groups. Each of the study interventions is to be delivered twice a week over eight
consecutive weeks. The school year for the targeted high school students lends itself to 8
waves of intervention. With 30 individuals per wave (randomized to 10 in each intervention
for any given wave), the investigators anticipate achieving our full subject pool in 5 waves.
Group nesting will be accounted for in the analytic plan.

The Smoking Prevention Informational Intervention (SPII) will be common to all randomized
conditions in the study. The investigators selected the intervention from brief primary-care
based interventions which followed the National Institutes of Health U.S. Public Health
Service Tobacco Use and Dependence Clinical Practice Guideline. Youth will be provided with
age-appropriate education on the norms and health consequences of smoking, affirmation of
their non-smoking status, and help in developing a personalized strategy to maintain
abstinence. Additionally, the investigators will incorporate a motivational interviewing
component. Many of these elements are consistent with elements used in the youth MI program
for adolescent smokers by Colby et al. (2005). The investigators will further incorporate
into the SPII intervention Colby and associates' guided imagery about future
smoking/non-smoking life status, and the initiation of our group sessions with open-ended
exploration of the perceived likes and dislikes about smoking, and, during 4 sessions,
provision of videotaped vignettes developed by the Massachusetts Department of Public Health
to stimulate discussion on four content areas: health effects, social consequences,
addiction, and financial cost. The SPII will be delivered following each of the 3 specific
intervention conditions described in the "Study Arms" section.

All of the groups will have 8 weeks of training sessions, with sessions scheduled twice per
week and each lasting up to 1 hour. Snacks will be served at these training sessions. In
addition, participants will be asked to practice class skills (e.g., 20 min of practice 3
times a week) outside of these sessions for approximately 1 hour per week (for the memory
program, this includes scheduling time in the computer room provided for this study).

Data Analysis Overview:

The following data analytic procedures are planned as of the current writing, but may be
modified to incorporate new, more rigorous statistical modeling approaches as they become

1. The feasibility/ acceptability of school- and community-based brief interventions will
be assessed by recruitment and attendance rates across the study period; acceptability
(attendance of 80% of interventions by 70% of the randomized sample) will be assessed
across the 3 conditions.

2. The investigators hypothesize that the WM+SPII and DT+SPII interventions, relative to
C+SPII, will lead to higher WM and higher DT, respectively. Further, the investigators
expect that WM will be higher in WM+SPII than in DT+SPII, and that DT will be higher in
DT+SPII than in WM+SPII. The latter contrast will indicate if the two active treatments
differ from each other on WM and/or DT; to perform these latter analyses, the
investigators will replace the dummy variable contrasting WM+SPII and C+SPII, with a
dummy variable comparing WM+SPII to DT+SPII.

3. To evaluate the impact of cognitive/affective target activation on proximal smoking
risk/behavior following intervention, WM and DT will both be added (simultaneously) as
time-varying predictors of outcome in MLM models for each of the 3 measures of smoking
risk (susceptibility to smoking, implicit attitudes toward smoking, and delay
discounting) and for actual smoking behavior (smoking behavior is dichotomous, so it
will be analyzed using a GLMM with a logistic linking function). The regression
coefficients for WM and DT predicting outcome in these models will indicate the degree
to which each is related to smoking risk over and above the other, and controlling for
the parallel change over time between these variables and the outcomes. This approach
calculates the relation between both WN and DT with proximal measures of smoking risk
within subjects over time. The Benjamini-Hochberg method will be used to correct for
multiple statistical tests.

Inclusion Criteria:

- Adolescents (ages 12 years or older) enrolled in high school as a freshman or

- Reflecting the demographics of the community in which we are recruiting, we expect
approximately 70% of the sample to be at or below the poverty level, balanced between
males and females, with the majority from an ethnic minority background.

Exclusion Criteria:

- Non-English speaking (operationalized as the inability to read and understand the
consent form and converse in spoken English)
We found this trial at
One Silber Way
Boston, Massachusetts 02215
(617) 353-2000
Principal Investigator: Michael W. Otto, Ph.D.
Phone: 617-353-9610
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