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

January 5, 2024 updated by: Julia Felton, Henry Ford Health System

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

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

Study Overview

Status

Enrolling by invitation

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 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.

Study Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Downtown Boxing Gym
      • Flint, Michigan, United States, 48504
        • Freedom Schools Collaborative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Arm
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.
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.

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, 7 weeks
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
Change in Consideration of Future Consequences Scale
Time Frame: 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 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
Change in Tower of Hanoi
Time Frame: 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 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
Change in Letter Number Sequencing
Time Frame: 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. Both intelligence batteries are widely used and normed on community and clinical populations.
Baseline, 7 weeks
Change in Iowa Gambling Task
Time Frame: 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. 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Youth Risk Behavior Survey
Time Frame: 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. 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
Change in Alcohol/Marijuana Effect Expectancies
Time Frame: 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. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Julia Felton, Henry Ford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

June 10, 2024

Study Completion (Estimated)

June 10, 2024

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TYBP: 15549-31
  • R34DA056732-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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