- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242704
Train Your Brain 2.0 - Improving Memory and Decision Making Among Youth
Train Your Brain 2.0: Improving Memory and Decision Making to Improve Outcomes Among Youth - A Randomized Controlled Trial
The goal of this clinical trial is to deliver a computer-based working memory training program to improve delay discounting (DD) and prevent substance misuse among at-risk adolescents in a traditionally underserved area. Results from the study will inform future 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 aims of the project are are:
1) To examine to examine changes in hypothesized mechanisms of substance use initiation and escalation, and 2) to assess whether changes in DD are a mechanism for reducing substance misuse during early adolescence. The investigators will evaluate whether changes in DD following active treatment predict substance use outcomes over the three-month follow-up period.
Study Overview
Status
Conditions
Intervention / Treatment
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 relative to 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.
Research from the investigative 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia Felton, PhD
- Phone Number: 7049957832
- Email: Jfelton4@hfhs.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Adolescent Inclusion Criteria:
- Between the ages of 11 and 15 and have a parent/guardian willing to provide consent for their participation
- Proficient in English
- Willing to commit to participate in computer-based trainings over the course of 5-8 weeks (duration dependent on site)
- Access to internet services, cell phone, and/or email
- Willing to receive/send study-related text messages
Adolescent Exclusion Criteria:
- Self-disclosure or identification with psychological disturbance, suicidality, or evidence of active suicide ideation
- Self-disclosure of current substance use disorder
Parent Inclusion Criteria:
- Provide consent for child's participation in study
- Proficient in English
- Access to internet services, cell phone, and/or email
- Willing to receive/send study-related text messages
Parent Exclusion Criteria:
- Self-disclosure or identification with psychosis, suicidality, or evidence of active suicide ideation
- Self-disclosure of current substance use disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Working Memory Training
The intervention is a computer-based training aimed at improving working memory in order to decrease delay discounting.
Active training sessions include: Sequenced Recall of Digits - Auditory, Sequenced Reverse Recall of Digits - Auditory, Sequenced Recall of Digits - Visual, Sequenced Reverse Recall of Digits - Visual, Sequenced Recall of Words - Auditory, Sequenced Recall of Words - Visual, Sequenced Reverse Recall of Words - Auditory, Sequenced Reverse Recall of Words - Visual.
Participants will complete at least 10 sessions with each session taking approximately 30 minutes to complete.
|
A multi-session computer-based working memory training program to improve delay discounting and prevent substance use among at-risk adolescents in a traditionally underserved area.
|
Active Comparator: Working Memory
The comparison control condition is a multi-session control computer training condition that is designed to not engage working memory during computer-based engagement sessions: Sequenced Recall of Digits - Auditory, Sequenced Reverse Recall of Digits - Auditory, Sequenced Recall of Digits - Visual, Sequenced Reverse Recall of Digits - Visual, Sequenced Recall of Words - Auditory, Sequenced Recall of Words - Visual, Sequenced Reverse Recall of Words - Auditory, Sequenced Reverse Recall of Words - Visual.
Participants will complete at least 10 sessions with each session taking approximately 30 minutes to complete.
|
A multi-session control computer training condition that is designed to not engage working memory among at-risk adolescents in a traditionally underserved area.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Delay Discounting 5 Trial Adjusted Measure
Time Frame: Baseline, 2 Weeks, 3 Months
|
The computer based adjusting amount discounting task uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years).At each delay, a choice is first presented between the delayed larger sum and a smaller sum available immediately.
For each trial, the position of the delayed and immediate amounts are randomly assigned the left or right portion of the screen, and the participant chooses the preferred option by pressing the corresponding left or right response button.
Change in the Delay Discounting score is measured by comparing baseline scores with scores at the intervention (baseline) and the post-intervention assessment (approximately 7 weeks after baseline)
|
Baseline, 2 Weeks, 3 Months
|
Change in Consideration of Future Consequences Scale
Time Frame: Baseline, 2 Weeks, 3 Months
|
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 behaviors1819 and greater substance use.
The measure has been used extensively among adult samples and demonstrates strong reliability and validity.
Research suggests modest but significant correlations with the MCQ.
Change in CFCS-14 score is measured by comparing baseline scores with scores at the post-intervention assessment (approximately 7 weeks after baseline)
|
Baseline, 2 Weeks, 3 Months
|
Change in Tower of Hanoi
Time Frame: Baseline, 2 Weeks, 3 Months
|
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 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).
|
Baseline, 2 Weeks, 3 Months
|
Change in Letter Number Sequencing
Time Frame: Baseline, 2 Weeks, 3 Months
|
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.
The investigators 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.
Both intelligence batteries are widely used and normed on community and clinical populations.
|
Baseline, 2 Weeks, 3 Months
|
Change in Iowa Gambling Task
Time Frame: Baseline, 2 Weeks, 3 Months
|
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.
The IGT has been shown to be valid in child and adolescent populations (Beitz, Salthouse & Davis, 2014; Smith, Xiao & Bechara, 2012).
|
Baseline, 2 Weeks, 3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Youth Risk Behavior Survey
Time Frame: Baseline, 2 Weeks, 3 Months
|
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.
Consistent with previous research, the investigators will create an aggregate of substance use and risk behaviors (e.g.
Aklin et al., 2005) as an index of risky behaviors.
Composite scores such as these have demonstrated adequate psychometric properties (e.g.
Felton, et al., 2015).
|
Baseline, 2 Weeks, 3 Months
|
Change in Alcohol Effect Expectancies
Time Frame: Baseline, 2 Weeks, 3 Months
|
The Alcohol Expectancy Questionnaire (AEQ; Brown, Christiansen, & Goldman, 1987) is a self-report questionnaire that tap youths' perception of positive and negative outcomes related to using alcohol.
Because this intervention is designed to orient youth towards longer-term (rather than immediate) rewards, the investigators expect to see significant decreases in positive expectancies of alcohol use and an increase in negative expectations.
The AEQ has been found to be reliable and valid indicators of adolescents' perceptions of use (Aarons et al., 2001; Brown et al., 1987).
|
Baseline, 2 Weeks, 3 Months
|
Change in Marijuana Effect Expectancies
Time Frame: Baseline, 2 Weeks, 3 Months
|
The Marijuana Effect Expectancy Questionnaire (MEEQ; Schafer & Brown, 1991) is a self-report questionnaire that tap youths' perception of positive and negative outcomes related to using marijuana.
Because this intervention is designed to orient youth towards longer-term (rather than immediate) rewards, the investigators expect to see significant decreases in positive expectancies of marijuana use and an increase in negative expectations.
The MEEQ has been found to be reliable and valid indicators of adolescents' perceptions of use (Aarons et al., 2001; Brown et al., 1987).
|
Baseline, 2 Weeks, 3 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B11256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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