Train Your Brain 2.0 - Improving Memory and Decision Making Among Youth

Behavior, Health Clinical Trial

Official title:

Train Your Brain 2.0: Improving Memory and Decision Making to Improve Outcomes Among Youth - A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242704
• Other study ID #: B11256
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 1, 2026

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: Julia Felton, PhD
• Phone: 7049957832
• Email: Jfelton4[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

Adolescent Inclusion Criteria:

1. Between the ages of 11 and 15 and have a parent/guardian willing to provide consent for their participation

2. Proficient in English

3. Willing to commit to participate in computer-based trainings over the course of 5-8 weeks (duration dependent on site)

4. Access to internet services, cell phone, and/or email

5. Willing to receive/send study-related text messages

Adolescent Exclusion Criteria:

1. Self-disclosure or identification with psychological disturbance, suicidality, or evidence of active suicide ideation

2. Self-disclosure of current substance use disorder

Parent Inclusion Criteria:

1. Provide consent for child's participation in study

2. Proficient in English

3. Access to internet services, cell phone, and/or email

4. Willing to receive/send study-related text messages

Parent Exclusion Criteria:

1. Self-disclosure or identification with psychosis, suicidality, or evidence of active suicide ideation

2. Self-disclosure of current substance use disorder

Related Conditions & MeSH terms

• Behavior, Health

Intervention

Behavioral:
• Working Memory Training
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.
• Working Memory
A multi-session control computer training condition that is designed to not engage working memory among at-risk adolescents in a traditionally underserved area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Delay Discounting 5 Trial Adjusted Measure	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
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 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
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 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
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. 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
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. 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	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. 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
Secondary	Change in Alcohol Effect Expectancies	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
Secondary	Change in Marijuana Effect Expectancies	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