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临床试验/NCT06076967
NCT06076967招募中不适用

Mindfulness Intervention for College Students With ADHD

University of Alabama, Tuscaloosa4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
4
主要终点
Attention Network Task

研究概览

简要总结

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that commonly persists into adulthood and is associated with significant life impairments. The current study evaluates the feasibility, acceptability, and preliminary efficacy of a group-based mindfulness intervention for first-year college students with ADHD. If found to be feasible, acceptable, and efficacious, subsequent research will examine its impact on a larger scale to have a broader public health impact for college students with ADHD.

详细描述

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that commonly persists into adulthood. Stimulant and non-stimulant pharmacotherapies are the mainstay of treatment; however, non- pharmacological interventions such as mindfulness have significant empirical support. The Mindful Awareness Practices (MAPs) for ADHD program, an 8-week, group-based mindfulness program for adults with ADHD, has been shown to reduce ADHD, depression, and anxiety symptoms. While promising, it is unknown as to whether the MAPs protocol is feasible, acceptable, and efficacious for college students with ADHD. The current study takes the first step towards enhanced study of mindfulness for college students with ADHD by testing the feasibility, acceptability, and preliminary efficacy of an adapted MAPs protocol delivered within university counseling center settings during the first semester of college. First-year college students with ADHD will be recruited at the University of Alabama and Wofford College. After developing and beta testing an adapted MAPs intervention at both sites, students will be randomized to adapted MAPs or Services-As-Usual (SAU; standard support services provided by the universities). Groups will include 10 first-year students and will be run over a 2-year period in the fall semesters (i.e., 4 MAPs groups across the two sites; total MAPs n = 40; total SAU n = 40). MAPs groups will be led by trained therapists in university counseling centers. Assessments will occur at pre, post, and 6-month follow-up using measures of ADHD, sluggish cognitive tempo (SCT), anxiety, and depression symptoms along with emotion regulation and mindfulness, our hypothesized mechanisms of change. Aims of the project are to: 1) adapt, manualize, and beta test the intervention, 2) conduct a pilot randomized controlled trial of adapted MAPs compared to SAU and examine feasibility and acceptability measures and clinical outcomes, and 3) examine whether the adapted MAPs intervention changes the targets hypothesized to be associated with changes in clinical outcomes (i.e., emotional regulation, mindfulness). If adequate feasibility, acceptability, and preliminary efficacy are documented, mindfulness for college students with ADHD can continue to be evaluated in larger trials. If ultimately found to be efficacious, this protocol has the potential to be widely disseminated within college counseling centers to have a broader public health impact for college students with ADHD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • First-semester college student with ADHD
  • Age 17-25
  • Must meet criteria for ADHD
  • No major medical problems

排除标准

  • Severe depression
  • Ongoing substance abuse
  • Personality disorder that may interfere with group delivery
  • Psychotic symptoms
  • Recent history of trauma
  • Unstable dosage of psychotropic medication

结局指标

主要结局

Attention Network Task

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This task measures aspects of attention such as alerting, orienting, and executive control.

Five-Facet Mindfulness Questionnaire

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses mindfulness in adults.

Conners Adult ADHD Rating Scale

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses adult ADHD symptoms

Adult Concentration Inventory

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses adult sluggish cognitive tempo (SCT) symptoms

Depression Anxiety Stress Scale-21

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses adult anxiety and depression symptoms

Difficulties in Emotion Regulation Scale

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses emotion regulation abilities in adults.

Trier Social Stress Test

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses the ability to regulate social stress in a laboratory paradigm.

Mind Excessively Wandering Questionnaire

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This measure assesses mind wandering in adults.

Sustained Attention to Response Task

时间窗: Pre-treatment, up to 1-month post-treatment, 6-month follow-up

This task measures the ability to sustain attention and mind wandering during task performance.

次要结局

  • Grade Point Average(6-month follow-up)
  • Behavior Rating Inventory of Executive Function - Adult Version(Pre-treatment, up to 1-month post-treatment, 6-month follow-up)
  • Social Functioning Questionnaire(Pre-treatment, up to 1-month post-treatment, 6-month follow-up)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Sponsor

研究点 (4)

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