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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA056732-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Arm | Experimental | All participants in this phase of the project will receive the active working memory training intervention (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-based Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 7 weeks |
| 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 . | Baseline, 7 weeks |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Youth Inclusion Criteria:
Youth Exclusion Criteria:
Parent Inclusion Criteria:
Parent Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Felton | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Downtown Boxing Gym | Detroit | Michigan | 48207 | United States | ||
| Freedom Schools Collaborative |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16549308 | Background | Dube SR, Miller JW, Brown DW, Giles WH, Felitti VJ, Dong M, Anda RF. Adverse childhood experiences and the association with ever using alcohol and initiating alcohol use during adolescence. J Adolesc Health. 2006 Apr;38(4):444.e1-10. doi: 10.1016/j.jadohealth.2005.06.006. | |
| 32795372 | Background | Afuseh E, Pike CA, Oruche UM. Individualized approach to primary prevention of substance use disorder: age-related risks. Subst Abuse Treat Prev Policy. 2020 Aug 14;15(1):58. doi: 10.1186/s13011-020-00300-7. |
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12 parents and 11 adolescents provided consent/assent to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of paretns and kids who completed the baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Parent sample (included 10 parents who reported on their own age out of the 11 parents who completed baseline assessment) and adolescent sample (include 11 adolescents who completed baseline) are reported separately below. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Number of adolescents particiapnts | Posted | Count of Participants | Participants | Baseline, 7 weeks |
|
Approximately three months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescents Computer-Based Working Memory Training Program | All youth participants received the active working memory training intervention (15, 20-30-minute computer-based training sessions over the course of 5 to 7 weeks). 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. |
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No current limitations or caveats.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julia Felton | Henry Ford Health | 313-598-0841 | jfelton4@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2024 | Sep 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2024 | Sep 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Baseline, 7 weeks |
| 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. | Baseline, 7 weeks |
| 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. | Baseline, 7 weeks |
| Baseline, 7 weeks |
| 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). | Baseline, 7 weeks |
| Flint |
| Michigan |
| 48504 |
| United States |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Parent sample (included 10 parents who reported on their own sex out of the 11 parents who completed baseline assessment) and adolescent sample (include 11 adolescents who completed baseline) are reported separately below. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Parent sample (included 10 parents who reported on their own ethnicity out of the 11 parents who completed baseline assessment) and adolescent sample (include 11 adolescents who completed baseline) are reported separately below. | Count of Participants | Participants |
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| Race (NIH/OMB) | Parent sample (including 11 parents who reported on their race) and adolescent sample (including 11 adolescents who completed baseline) are reported separately below. | Count of Participants | Participants |
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| Region of Enrollment | Adult participants | Number | participants |
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| Region of Enrollment | Adolescent Participants | Number | participants |
|
| OG000 |
| 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. |
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| Primary | 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 . | Adolescent participants who completed both the baseline and follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| Primary | 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). | Adolescent participants who completed measure at baseline and post-training. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| Primary | 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. | Adolescent participants who completed measure at baseline and post-training. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| Primary | 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. | Adolescent participants who completed measure at baseline and post-training. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| Secondary | 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). | Adolescent participants who completed this item at baseline and post-training. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| Secondary | 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). | Adolescent participants who completed measure at baseline and post-training. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Parents | Parents of youth participating in the computer-based working memory training program | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| AEQ-negative Post-Training Assessment |
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| MEEQ-positive Baseline Assessment |
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| MEEQ-positive Post-Training Assessment |
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| MEEQ-negative Baseline Assessment |
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| MEEQ-negative Post-Training Assessment |
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| .320 |
| Superiority |
| Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores. | t-test, 1 sided | .049 | Superiority |
| Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores. | t-test, 1 sided | .089 | Superiority |