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临床试验/NCT05879198
NCT05879198已完成不适用

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

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Number of Participants With Change in Delay Discounting 5 Trial Adjusted Measure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Youth Inclusion Criteria:
  • •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

排除标准

  • •Currently psychotic
  • •Currently suicidal or evidence active suicidal ideation
  • •Currently diagnosed with a substance use disorder
  • •Parent Inclusion Criteria:
  • •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
  • •Parent Exclusion Criteria:
  • •Currently psychotic
  • •Currently suicidal or evidence active suicidal ideation
  • •Currently diagnosed with a substance use disorder

研究组 & 干预措施

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.

干预措施: Computer-based Intervention (Behavioral)

结局指标

主要结局

Number of Participants With Change in Delay Discounting 5 Trial Adjusted Measure

时间窗: Baseline, 7 weeks

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).

Change in Consideration of Future Consequences Scale

时间窗: 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 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 .

Change in Tower of Hanoi

时间窗: 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 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).

Change in Letter Number Sequencing

时间窗: 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. 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.

Change in Iowa Gambling Task

时间窗: 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. 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.

次要结局

  • Change in Alcohol/Marijuana Effect Expectancies(Baseline, 7 weeks)
  • Change in Youth Risk Behavior Survey(Baseline, 7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Felton

Associate Scientist

Henry Ford Health System

研究点 (2)

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