Train Your Brain: A Pilot Project to Improve Memory and Decision Making

Behavior, Health Clinical Trial

Official title:

Train Your Brain: A Pilot Project to Improve Memory and Decision Making to Improve Outcomes Among Youth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05879198
• Other study ID #: TYBP: 15549-31
• Secondary ID: R34DA056732-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 23
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 Exclusion Criteria:

1. Currently psychotic

2. Currently suicidal or evidence active suicidal ideation

3. Currently diagnosed with a substance use disorder

Related Conditions & MeSH terms

• Behavior, Health

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Downtown Boxing Gym	Detroit	Michigan
United States	Freedom Schools Collaborative	Flint	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Henry Ford Health System	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 137 references in all — Click here to view all references

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, 7 weeks
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, 7 weeks
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, 7 weeks
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. Both intelligence batteries are widely used and normed on community and clinical populations.	Baseline, 7 weeks
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, 7 weeks
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, we 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, 7 weeks
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. Because our intervention is designed to orient youth towards longer-term (rather than immediate) rewards, we expect to see significant decreases in positive expectancies of alcohol and marijuana use and an increase in negative expectations. Both the AEQ and MEEQ have been found to be reliable and valid indicators of adolescents' perceptions of use (Aarons et al., 2001; Brown et al., 1987).	Baseline, 7 weeks