Trial Outcomes & Findings for Cognitive and Emotional Skills to Aid Smoking Prevention (NCT NCT03058991)

Last Updated: 2021-07-23

Results Overview

Feasibility/acceptability of each intervention (indexed by attendance of at least 80% of interventions by 70% of the randomized sample) will be assessed.

Recruitment status

COMPLETED

Study phase

Target enrollment

124 participants

Primary outcome timeframe

Intervention (week 1 to week 8)

Results posted on

2021-07-23

Participant Flow

Of 124 consented individuals, 108 were randomized and attended at least 1 session.

Participant milestones

Participant milestones
Measure	Working Memory Intervention Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.	Control Informational Intervention This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.	Distress Tolerance Intervention For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
Overall Study STARTED	39	32	37
Overall Study 1-Week Follow Up	23	27	28
Overall Study COMPLETED	21	20	25
Overall Study NOT COMPLETED	18	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Working Memory Intervention Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.	Control Informational Intervention This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.	Distress Tolerance Intervention For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
Overall Study Lost to Follow-up	17	12	12
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Statistics are based on all cases with valid data for all variables in the model.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Working Memory Intervention n=39 Participants Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.	Control Informational Intervention n=32 Participants This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.	Distress Tolerance Intervention n=37 Participants For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=39 Participants	32 Participants n=32 Participants	37 Participants n=37 Participants	108 Participants n=108 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=32 Participants	0 Participants n=37 Participants	0 Participants n=108 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=32 Participants	0 Participants n=37 Participants	0 Participants n=108 Participants
Age, Continuous	13.8 years STANDARD_DEVIATION 1.3 • n=39 Participants	14.2 years STANDARD_DEVIATION 1.3 • n=32 Participants	14.1 years STANDARD_DEVIATION 1.2 • n=37 Participants	14 years STANDARD_DEVIATION 1.3 • n=108 Participants
Sex: Female, Male Female	19 Participants n=39 Participants	20 Participants n=32 Participants	20 Participants n=37 Participants	59 Participants n=108 Participants
Sex: Female, Male Male	20 Participants n=39 Participants	12 Participants n=32 Participants	17 Participants n=37 Participants	49 Participants n=108 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=39 Participants	18 Participants n=32 Participants	17 Participants n=37 Participants	54 Participants n=108 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=39 Participants	14 Participants n=32 Participants	19 Participants n=37 Participants	52 Participants n=108 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	0 Participants n=32 Participants	1 Participants n=37 Participants	2 Participants n=108 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=39 Participants	12 Participants n=32 Participants	14 Participants n=37 Participants	39 Participants n=108 Participants
Race/Ethnicity, Customized Alaska Native or American Indian	0 Participants n=39 Participants	0 Participants n=32 Participants	0 Participants n=37 Participants	0 Participants n=108 Participants
Race/Ethnicity, Customized Asian	1 Participants n=39 Participants	0 Participants n=32 Participants	2 Participants n=37 Participants	3 Participants n=108 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=39 Participants	0 Participants n=32 Participants	0 Participants n=37 Participants	1 Participants n=108 Participants
Race/Ethnicity, Customized White	1 Participants n=39 Participants	2 Participants n=32 Participants	0 Participants n=37 Participants	3 Participants n=108 Participants
Race/Ethnicity, Customized Other	21 Participants n=39 Participants	16 Participants n=32 Participants	18 Participants n=37 Participants	55 Participants n=108 Participants
Race/Ethnicity, Customized Decline to State	0 Participants n=39 Participants	1 Participants n=32 Participants	2 Participants n=37 Participants	3 Participants n=108 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=39 Participants	0 Participants n=32 Participants	0 Participants n=37 Participants	0 Participants n=108 Participants
Race/Ethnicity, Customized Unknown or Unreported	2 Participants n=39 Participants	1 Participants n=32 Participants	1 Participants n=37 Participants	4 Participants n=108 Participants
Region of Enrollment United States	39 participants n=39 Participants	32 participants n=32 Participants	37 participants n=37 Participants	108 participants n=108 Participants
Distress Tolerance	.01 z-score STANDARD_DEVIATION .60 • n=38 Participants • Statistics are based on all cases with valid data for all variables in the model.	-.01 z-score STANDARD_DEVIATION .76 • n=32 Participants • Statistics are based on all cases with valid data for all variables in the model.	-.25 z-score STANDARD_DEVIATION .78 • n=37 Participants • Statistics are based on all cases with valid data for all variables in the model.	-.09 z-score STANDARD_DEVIATION .72 • n=107 Participants • Statistics are based on all cases with valid data for all variables in the model.
Smoking Susceptibility Assessment (SSA)	.23 Natural Log of Scores on a Scale STANDARD_DEVIATION .51 • n=39 Participants	.29 Natural Log of Scores on a Scale STANDARD_DEVIATION .49 • n=32 Participants	.43 Natural Log of Scores on a Scale STANDARD_DEVIATION .57 • n=37 Participants	.31 Natural Log of Scores on a Scale STANDARD_DEVIATION .53 • n=108 Participants
Smoking Brief Implicit Association Test (B-IAT)	.48 Standardized Difference Scores STANDARD_DEVIATION .63 • n=37 Participants • Statistics are based on all cases with valid data for all variables in the model.	.64 Standardized Difference Scores STANDARD_DEVIATION .44 • n=27 Participants • Statistics are based on all cases with valid data for all variables in the model.	.64 Standardized Difference Scores STANDARD_DEVIATION .51 • n=35 Participants • Statistics are based on all cases with valid data for all variables in the model.	.58 Standardized Difference Scores STANDARD_DEVIATION .54 • n=99 Participants • Statistics are based on all cases with valid data for all variables in the model.
Delay Discounting task	-2.9 Natural log of k-value STANDARD_DEVIATION 2.6 • n=38 Participants • Statistics are based on all cases with valid data for all variables in the model.	-3.1 Natural log of k-value STANDARD_DEVIATION 1.9 • n=32 Participants • Statistics are based on all cases with valid data for all variables in the model.	-2.7 Natural log of k-value STANDARD_DEVIATION 2.3 • n=37 Participants • Statistics are based on all cases with valid data for all variables in the model.	-2.9 Natural log of k-value STANDARD_DEVIATION 2.3 • n=107 Participants • Statistics are based on all cases with valid data for all variables in the model.
Work Memory Capacity	-.16 z-score STANDARD_DEVIATION .62 • n=39 Participants	-.17 z-score STANDARD_DEVIATION .68 • n=32 Participants	.08 z-score STANDARD_DEVIATION .70 • n=37 Participants	-.08 z-score STANDARD_DEVIATION .67 • n=108 Participants
Actual Smoking Status	.11 Proportions of Smokers STANDARD_DEVIATION .31 • n=38 Participants • Statistics are based on all cases with valid data for all variables in the model.	.16 Proportions of Smokers STANDARD_DEVIATION .37 • n=32 Participants • Statistics are based on all cases with valid data for all variables in the model.	.11 Proportions of Smokers STANDARD_DEVIATION .32 • n=36 Participants • Statistics are based on all cases with valid data for all variables in the model.	.12 Proportions of Smokers STANDARD_DEVIATION .33 • n=106 Participants • Statistics are based on all cases with valid data for all variables in the model.

PRIMARY outcome

Timeframe: Intervention (week 1 to week 8)

Population: Percentage of individuals who attended at least 80% of interventions reported.

Feasibility/acceptability of each intervention (indexed by attendance of at least 80% of interventions by 70% of the randomized sample) will be assessed.

Outcome measures

Outcome measures
Measure	Working Memory Intervention n=39 Participants Participants were asked to use the CogMed RM program, while supervised twice a week, each time for an hour, for 8 weeks. Participants were also asked to use the program on the other days for 25-35 minutes. The program resembles a video game, and comprises several different "games" that require visuo-spatial working memory (remembering the position of objects) and a combination of verbal and visual working memory (remembering phonemes, letters, and digits). The program adapts to the user's performance, such that trainees are able to perform at the limit of their ability, stimulating WM capacity adaptation.	Control Informational Intervention n=32 Participants This Control Informational Intervention has been used in the investigators' and other's previous studies. In this application, it matched the session time of the Distress Tolerance and Working Memory interventions and omitted a focus on smoking (which is specific to the SPII intervention provided across all interventions), and will consist of discussions of a variety of healthy lifestyle topics, such as healthy eating, stress/time management, and recommended health screenings.	Distress Tolerance Intervention n=37 Participants For the Distress Tolerance Intervention, the investigators used a Mindfulness Based Stress Reduction (MBSR) program that has been adapted for use with adolescents. This version of MBSR follows closely the original conceptualization developed by Kabat-Zinn. The focus is on formal and informal mindfulness practices, which encourage participants to foster intention, attention and attitude. The investigators made slight modifications to the delivery of the MBSR intervention to take into account the developmental period of their participants (e.g., attention span) to encourage retention and increase relevancy. These changes allow the investigators to match the duration with their Working Memory Intervention.
Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions	41.0 percentage of participants	50 percentage of participants	40.5 percentage of participants

PRIMARY outcome

Timeframe: 1 Week

Assessment includes three computer-administered WM performance measures (N-back, Auditory Digit Span, and Corsi Block Tapping task) which are z-scored and aggregated to create a single WM index.The Working Memory Capacity Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater capacity.