NCT05879198

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 28, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

May 18, 2023

Results QC Date

September 7, 2024

Last Update Submit

March 12, 2025

Conditions

Keywords

delay discountingcomputer-based interventionexecutive functioningsubstance useworking memory

Outcome Measures

Primary Outcomes (5)

  • 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).

    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

Secondary Outcomes (2)

  • Change in Youth Risk Behavior Survey

    Baseline, 7 weeks

  • Change in Alcohol/Marijuana Effect Expectancies

    Baseline, 7 weeks

Study Arms (1)

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.

Behavioral: Computer-based Intervention

Interventions

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.

Single-Arm

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth must be between the ages of 12 and 14 and have a parent/guardian willing to provide consent for their participation
  • Youth must be proficient in English in order to validly complete all assessment measures and take part in the computer-based training
  • Youth must be willing to commit to participate in two to three 20-30-minute computer-based trainings for five to seven weeks
  • 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

You may not qualify if:

  • Currently psychotic
  • Currently suicidal or evidence active suicidal ideation
  • Currently diagnosed with a substance use disorder
  • Parent of child participating in intervention and willing to provide consent for themselves and their children to participate
  • Proficient in English in order to validly complete all assessment measures
  • Willing to take part in assessments
  • Currently psychotic
  • Currently suicidal or evidence active suicidal ideation
  • Currently diagnosed with a substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Downtown Boxing Gym

Detroit, Michigan, 48207, United States

Location

Freedom Schools Collaborative

Flint, Michigan, 48504, United States

Location

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MeSH Terms

Conditions

Health BehaviorSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental Disorders

Limitations and Caveats

No current limitations or caveats.

Results Point of Contact

Title
Dr. Julia Felton
Organization
Henry Ford Health

Study Officials

  • Julia Felton

    Henry Ford Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

June 15, 2023

Primary Completion

September 7, 2023

Study Completion

September 7, 2023

Last Updated

March 28, 2025

Results First Posted

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations