Behavior, Health
Conditions
Keywords
delay discounting, computer-based intervention, executive functioning, substance use, working memory
Brief summary
The goal of this clinical trial is to pilot a computer-based working memory training program to improve delay discounting (DD) and prevent substance use among at-risk adolescents in a traditionally underserved area. Results from the study will inform future efforts substance use prevention efforts targeted at youth exposed to adverse childhood experiences. Findings will also refine future models of intervention delivery in traditionally underserved communities. The main question\[s\] it aims to answer are: * Determine if the intervention can be delivered feasibly, acceptability, and at sufficient dosage * Evaluate the utility of the recruitment and retention procedures as well as identify barriers to participation
Detailed description
Youth exposed to early childhood adversity are at increased risk for engaging in problematic substance use, leading to myriad negative health outcomes, including HIV exposure, injury, and impaired driving. Adolescents from low-resource communities evidence elevated rates of exposure to adverse childhood experiences, yet have limited access to evidence-based preventative interventions. Thus, there is a critical need for services that can feasibly target specific mechanisms linking early adversity to the onset and escalation of substance use in traditionally underserved communities. One such target is delay discounting (DD), the tendency to select small, immediately available rewards at the expense of larger, delayed, rewards. DD has been linked to early substance use initiation and more frequent and severe use across adolescence. Moreover, youth exposed to early childhood adversity evidence more problematic levels of DD, indicating that DD may be a pathway by which early trauma exposure leads to drug and alcohol use. Iterative pilot trials of approximately 10 youth participants + their parents/guardians will be conducted to examine effectiveness of procedures and initial implementation outcomes. Research from our team suggests that computer-based interventions targeting proximal cognitive skills, specifically working memory, can improve rates of DD. Moreover, computerized interventions are highly transportable and scalable, making them ideal for dissemination in low-resource communities. The current project proposes to pilot a computer-based working memory (WM) training program to improve DD and prevent substance use among at-risk adolescents in a traditionally underserved area.
Interventions
The current project proposes to pilot a computer-based working memory training program to improve delay discounting and prevent substance use among at-risk adolescents in a traditionally underserved area.
Sponsors
Study design
Eligibility
Inclusion criteria
Youth Inclusion Criteria: 1. Youth must be between the ages of 12 and 14 and have a parent/guardian willing to provide consent for their participation 2. Youth must be proficient in English in order to validly complete all assessment measures and take part in the computer-based training 3. Youth must be willing to commit to participate in two to three 20-30-minute computer-based trainings for five to seven weeks 4. Youth must be willing to take part in assessments before and immediately following the intervention as well as a confidential interview with researchers after completing the computer sessions Youth
Exclusion criteria
1. Currently psychotic 2. Currently suicidal or evidence active suicidal ideation 3. Currently diagnosed with a substance use disorder Parent Inclusion Criteria: 1. Parent of child participating in intervention and willing to provide consent for themselves and their children to participate 2. Proficient in English in order to validly complete all assessment measures 3. Willing to take part in assessments Parent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Consideration of Future Consequences Scale | Baseline, 7 weeks | The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors and greater substance use. Individual items are rated on a scale from 1 to 7; items are summed to create a total scores ranging from 14-98. Change in CFCS-14 score is measured by comparing baseline scores with scores at the post-intervention assessment with higher scores reflecting greater increases in future thinking . |
| Change in Letter Number Sequencing | Baseline, 7 weeks | Letter Number Sequencing (LNS) is a measure of working memory. The participant is read a list of scrambled letters and numbers that they must then repeat back to the examiner in alphabetical and numeric order. The length of the target string increases over time until the participant is no longer able to correctly sequence three letter/ number stems in a row. We will utilize the LNS subscale from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-5; Wechsler, 2014) for participants between 12 and 16, and the Wechsler Adult Intelligence Scale (WAIS-IV; Wechsler, 2008) for participants age 17. Higher scores indicate better outcomes with, total raw summed scores ranging from 0 to 30. Both intelligence batteries are widely used and normed on community and clinical populations. |
| Change in Iowa Gambling Task | Baseline, 7 weeks | Iowa Gambling Task (IGT; Bechara et al., 1994) evaluates experiential decision making. It is administered via a computer interface, in which participants are presented four decks of cards and asked to select one deck to flip a card from in order to win money. Each deck is associated with specific winning and losing probabilities and performance on the task is determined by computing relative preference for longer vs. shorter-term rewards. Advantageous choices are summed and total scores range for -100 to +100 with higher scores indicating a higher proportion of advantageous choices suggesting a better performance. |
| Number of Participants With Change in Delay Discounting 5 Trial Adjusted Measure | Baseline, 7 weeks | This measure asks participants to select between a smaller monetary amount available now and a larger monetary amount available at a delay (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). K-values, reflecting the indifference points at which participants preference between smaller and larger rewards, are computed. Because k-values are typically skewed, they are log-transformed before analysis. Scores are not bounded with a minimum and maximum value, but higher scores indicate a preference for smaller-sooner rewards relative to larger rewards available after a delay. Number of participants with change in the Delay Discounting score is defined as participants who evidenced a decrease from baseline scores to post-intervention assessment indicating a greater willingness to wait for larger rewards (which has been associated with healthier outcomes). |
| Change in Tower of Hanoi | Baseline, 7 weeks | Tower of Hanoi (TOH) is a measure of planning ahead. It requires the participant to move disks of varying sizes between three pegs in order to create a specified design. Participants are instructed to follow specific rules for play and are awarded points for making each design in the least number of moves. The minimum overall score a participant can get is zero and the maximum score is 72, with higher scores indicating better performance. The current study will use the TOH measure from the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001). The test is normed on clinical and community samples of individuals ages 8 to 89 years old and demonstrates adequate reliability and validity (Delis et al. 2004). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol/Marijuana Effect Expectancies | Baseline, 7 weeks | The Alcohol Expectancy Questionnaire (AEQ; Brown, Christiansen, & Goldman, 1987) and the Marijuana Effect Expectancy Questionnaire (MEEQ; Schafer & Brown, 1991) are self-report questionnaires that tap youths' perception of positive and negative outcomes related to using alcohol and marijuana. Both measures report on youth positive (AEQ-positive - 4 items; MEEQ-positive - 3 items) and negative (AEQ-negative - 3 items, MEEQ-negative - 3 items) expectations. Each item is ranked on a 5-point Likert scale (1=disagree strongly to 5=agree strongly) and summed. Scores on the AEQ-positive range from 4-20 with higher scores indicating greater positive expectancies, and all other subscale scores ranging from 3-15 with higher scores indicating higher positive (MEEQ-positive) or negative expectancies (AEQ-negative, MEEQ-negative). |
| Change in Youth Risk Behavior Survey | Baseline, 7 weeks | The Youth Risk Behavior Survey (YRBS; CDC, 2001) is a self-report measure of the prevalence of real world risk behaviors, including compromised safety behaviors (e.g. not wearing a seat belt), substance use, risky sexual practices, and delinquent behaviors (e.g. gambling, theft). Because substance use has been associated with problematic behaviors more broadly (Bukstein, 2000), the YRBS will allow us to tap engagement in a variety of related risky behaviors. We looked at changes in a single item assessing on how many of the last 30 days a participant had at least one sip of alcohol. Possible scores ranged from 0 (indicating zero days of drinking in the last 30 days) to 6 (indicating drinking every day over the last 30 days). |
Countries
United States
Participant flow
Recruitment details
12 parents and 11 adolescents provided consent/assent to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Computer-Based Working Memory Training Program All participants in this phase of the project will receive the active working memory training intervention (up to 15, 20-30-minute computer-based training sessions over the course of 5 to 7 weeks). Additionally, key stakeholders will be asked to participate in a qualitative interview following the intervention to refine future models of intervention delivery in traditionally underserved communities.
Computer-based Intervention: The current project proposes to pilot a computer-based working memory training program to improve delay discounting and prevent substance use among at-risk adolescents in a traditionally underserved area. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Computer-Based Working Memory Training Program |
|---|---|
| Age, Continuous Adolescent Participants | 12.5 years STANDARD_DEVIATION 0.8 |
| Age, Continuous Parent Participants | 40.9 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Adolescent Participants Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Adolescent Participants Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Adolescent Participants Unknown or Not Reported | 1 Participants |
| Ethnicity (NIH/OMB) Adult Participants Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Adult Participants Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Adult Participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adolescent Participants American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Adolescent Participants Asian | 0 Participants |
| Race (NIH/OMB) Adolescent Participants Black or African American | 9 Participants |
| Race (NIH/OMB) Adolescent Participants More than one race | 1 Participants |
| Race (NIH/OMB) Adolescent Participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adolescent Participants Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Adolescent Participants White | 0 Participants |
| Race (NIH/OMB) Adult participants American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Adult participants Asian | 0 Participants |
| Race (NIH/OMB) Adult participants Black or African American | 9 Participants |
| Race (NIH/OMB) Adult participants More than one race | 0 Participants |
| Race (NIH/OMB) Adult participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adult participants Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) Adult participants White | 1 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Adolescent participants Female | 1 Participants |
| Sex: Female, Male Adolescent participants Male | 10 Participants |
| Sex: Female, Male Adult participants reporting sex Female | 9 Participants |
| Sex: Female, Male Adult participants reporting sex Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Change in Consideration of Future Consequences Scale
The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors and greater substance use. Individual items are rated on a scale from 1 to 7; items are summed to create a total scores ranging from 14-98. Change in CFCS-14 score is measured by comparing baseline scores with scores at the post-intervention assessment with higher scores reflecting greater increases in future thinking .
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed both the baseline and follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Consideration of Future Consequences Scale | Baseline assessment | 58.4 score on a scale | Standard Deviation 7.3 |
| Computer-based Working Memory Training Program | Change in Consideration of Future Consequences Scale | Post-training assessment | 58.7 score on a scale | Standard Deviation 10.9 |
Change in Iowa Gambling Task
Iowa Gambling Task (IGT; Bechara et al., 1994) evaluates experiential decision making. It is administered via a computer interface, in which participants are presented four decks of cards and asked to select one deck to flip a card from in order to win money. Each deck is associated with specific winning and losing probabilities and performance on the task is determined by computing relative preference for longer vs. shorter-term rewards. Advantageous choices are summed and total scores range for -100 to +100 with higher scores indicating a higher proportion of advantageous choices suggesting a better performance.
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed measure at baseline and post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Iowa Gambling Task | Baseline Assessment | 42.3 score on a scale | Standard Deviation 23.7 |
| Computer-based Working Memory Training Program | Change in Iowa Gambling Task | Post-Training Assessment | 46.3 score on a scale | Standard Deviation 26.5 |
Change in Letter Number Sequencing
Letter Number Sequencing (LNS) is a measure of working memory. The participant is read a list of scrambled letters and numbers that they must then repeat back to the examiner in alphabetical and numeric order. The length of the target string increases over time until the participant is no longer able to correctly sequence three letter/ number stems in a row. We will utilize the LNS subscale from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-5; Wechsler, 2014) for participants between 12 and 16, and the Wechsler Adult Intelligence Scale (WAIS-IV; Wechsler, 2008) for participants age 17. Higher scores indicate better outcomes with, total raw summed scores ranging from 0 to 30. Both intelligence batteries are widely used and normed on community and clinical populations.
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed measure at baseline and post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Letter Number Sequencing | Baseline Assessment | 9.14 score on a scale | Standard Deviation 1.2 |
| Computer-based Working Memory Training Program | Change in Letter Number Sequencing | Post-Training Assessment | 9.86 score on a scale | Standard Deviation 2.7 |
Change in Tower of Hanoi
Tower of Hanoi (TOH) is a measure of planning ahead. It requires the participant to move disks of varying sizes between three pegs in order to create a specified design. Participants are instructed to follow specific rules for play and are awarded points for making each design in the least number of moves. The minimum overall score a participant can get is zero and the maximum score is 72, with higher scores indicating better performance. The current study will use the TOH measure from the Delis-Kaplan Executive Function System (D-KEFS; Delis, Kaplan & Kramer, 2001). The test is normed on clinical and community samples of individuals ages 8 to 89 years old and demonstrates adequate reliability and validity (Delis et al. 2004).
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed measure at baseline and post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Tower of Hanoi | Post-training Assessment | 50.9 score on a scale | Standard Deviation 16.4 |
| Computer-based Working Memory Training Program | Change in Tower of Hanoi | Baseline Assessment | 51.36 score on a scale | Standard Deviation 4.9 |
Number of Participants With Change in Delay Discounting 5 Trial Adjusted Measure
This measure asks participants to select between a smaller monetary amount available now and a larger monetary amount available at a delay (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). K-values, reflecting the indifference points at which participants preference between smaller and larger rewards, are computed. Because k-values are typically skewed, they are log-transformed before analysis. Scores are not bounded with a minimum and maximum value, but higher scores indicate a preference for smaller-sooner rewards relative to larger rewards available after a delay. Number of participants with change in the Delay Discounting score is defined as participants who evidenced a decrease from baseline scores to post-intervention assessment indicating a greater willingness to wait for larger rewards (which has been associated with healthier outcomes).
Time frame: Baseline, 7 weeks
Population: Number of adolescents particiapnts
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Computer-based Working Memory Training Program | Number of Participants With Change in Delay Discounting 5 Trial Adjusted Measure | 3 Participants |
Change in Alcohol/Marijuana Effect Expectancies
The Alcohol Expectancy Questionnaire (AEQ; Brown, Christiansen, & Goldman, 1987) and the Marijuana Effect Expectancy Questionnaire (MEEQ; Schafer & Brown, 1991) are self-report questionnaires that tap youths' perception of positive and negative outcomes related to using alcohol and marijuana. Both measures report on youth positive (AEQ-positive - 4 items; MEEQ-positive - 3 items) and negative (AEQ-negative - 3 items, MEEQ-negative - 3 items) expectations. Each item is ranked on a 5-point Likert scale (1=disagree strongly to 5=agree strongly) and summed. Scores on the AEQ-positive range from 4-20 with higher scores indicating greater positive expectancies, and all other subscale scores ranging from 3-15 with higher scores indicating higher positive (MEEQ-positive) or negative expectancies (AEQ-negative, MEEQ-negative).
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed measure at baseline and post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | AEQ-negative Baseline Assessment | 9.4 score on a scale | Standard Deviation 3.5 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | AEQ-negative Post-Training Assessment | 10.1 score on a scale | Standard Deviation 3.6 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | MEEQ-positive Baseline Assessment | 10.6 score on a scale | Standard Deviation 3.1 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | MEEQ-negative Baseline Assessment | 7.6 score on a scale | Standard Deviation 1.9 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | MEEQ-negative Post-Training Assessment | 8.1 score on a scale | Standard Deviation 1.8 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | MEEQ-positive Post-Training Assessment | 12.7 score on a scale | Standard Deviation 3.8 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | AEQ-positive Baseline Assessment | 7 score on a scale | Standard Deviation 1.9 |
| Computer-based Working Memory Training Program | Change in Alcohol/Marijuana Effect Expectancies | AEQ-positive Post-Training Assessment | 8.1 score on a scale | Standard Deviation 2.9 |
Change in Youth Risk Behavior Survey
The Youth Risk Behavior Survey (YRBS; CDC, 2001) is a self-report measure of the prevalence of real world risk behaviors, including compromised safety behaviors (e.g. not wearing a seat belt), substance use, risky sexual practices, and delinquent behaviors (e.g. gambling, theft). Because substance use has been associated with problematic behaviors more broadly (Bukstein, 2000), the YRBS will allow us to tap engagement in a variety of related risky behaviors. We looked at changes in a single item assessing on how many of the last 30 days a participant had at least one sip of alcohol. Possible scores ranged from 0 (indicating zero days of drinking in the last 30 days) to 6 (indicating drinking every day over the last 30 days).
Time frame: Baseline, 7 weeks
Population: Adolescent participants who completed this item at baseline and post-training.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer-based Working Memory Training Program | Change in Youth Risk Behavior Survey | Baseline Assessment | 0 score on a scale | Standard Deviation 0 |
| Computer-based Working Memory Training Program | Change in Youth Risk Behavior Survey | Post-training Assessment | 0 score on a scale | Standard Deviation 0 |