N/A
N=108
Cognitive and Emotional Skills to Aid Smoking Prevention
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03058991 ↗Enrolled (actual)
108
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions — 41.0; 50; 40.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Distress Tolerance Intervention (Behavioral); Working Memory Intervention (Behavioral); Control Informational Intervention (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions |
41.0; 50; 40.5 | — |
| PRIMARY Specific Aim 2: Working Memory Capacity |
.06; .01; .25 | — |
| PRIMARY Specific Aim 2: Distress Tolerance |
.17; .24; -.04 | — |
| PRIMARY Specific Aim 3: Smoking Risk (Standard Smoking Assessment) |
.25; .29; .31 | — |
| PRIMARY Specific Aim 3: Smoking Risk (B-IAT) |
.19; .24; .16 | — |
| PRIMARY Specific Aim 3: Smoking Risk (Delay Discounting Task) |
-2.95; -3.69; -3.27 | — |
| PRIMARY Specific Aim 4: Actual Smoking Status |
.10; .00; .08 | — |
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 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 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 risk/behavior and related health outcomes following intervention.
Eligibility Criteria
Inclusion Criteria
- Adolescents (ages 12 years or older) enrolled in high school as a freshman or sophomore.
- 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)
Data sourced from ClinicalTrials.gov (NCT03058991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.