Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03058991
Status:
COMPLETED
Last Update Posted:
2021-07-23
First Post:
2016-10-07
Brief Title:
Cognitive and Emotional Skills to Aid Smoking Prevention
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Rescuing Cognitive and Emotional Regulatory Processes to Aid Smoking Prevention
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOAN
Brief Summary:
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 cognitiveaffective 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 adolescents
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 maintenance
3 The impact of cognitive affective target activation on proximal measures of smoking riskbehavior and related health outcomes following intervention
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 adolescents
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 maintenance
3 The impact of cognitive affective target activation on proximal measures of smoking riskbehavior and related health outcomes following intervention
Detailed Description:
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 CSPII 2 a Working Memory intervention delivered prior to a smoking prevention informational intervention WMSPII 3 a Distress Tolerance Intervention delivered prior to a smoking prevention informational intervention DTSPII 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 eg 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 US 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 smokingnon-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 eg 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 available
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 WMSPII and DTSPII interventions relative to CSPII will lead to higher WM and higher DT respectively Further the investigators expect that WM will be higher in WMSPII than in DTSPII and that DT will be higher in DTSPII than in WMSPII The latter contrast will indicate if the two active treatments differ from each other on WM andor DT to perform these latter analyses the investigators will replace the dummy variable contrasting WMSPII and CSPII with a dummy variable comparing WMSPII to DTSPII
3 To evaluate the impact of cognitiveaffective target activation on proximal smoking riskbehavior 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
Research material will consist of participant self-report of smoking peer smoking and parental smoking as well as self-report of personality characteristics eg 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 US 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 smokingnon-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 eg 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 available
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 WMSPII and DTSPII interventions relative to CSPII will lead to higher WM and higher DT respectively Further the investigators expect that WM will be higher in WMSPII than in DTSPII and that DT will be higher in DTSPII than in WMSPII The latter contrast will indicate if the two active treatments differ from each other on WM andor DT to perform these latter analyses the investigators will replace the dummy variable contrasting WMSPII and CSPII with a dummy variable comparing WMSPII to DTSPII
3 To evaluate the impact of cognitiveaffective target activation on proximal smoking riskbehavior 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DA041531 | NIH | None | httpsreporternihgovquickSearchR21DA041531 |