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临床试验/NCT05584475
NCT05584475已完成不适用

Mindful Awareness Practices for ADHD (MAPs): Pilot Open Trial

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年10月5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
16
试验地点
1
主要终点
Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM)

研究概览

简要总结

It is estimated that 25-40% of youth with ADHD have co-occurring cognitive disengagement syndrome (CDS; previously sluggish cognitive tempo), a set of behavioral symptoms characterized by excessive daydreaming, slowed thinking, and mental confusion and fogginess. A growing body of research demonstrates CDS to be associated with functional impairment above and beyond that which can be accounted for by ADHD severity. However, no treatment currently exists that directly targets CDS symptoms. This is a critical clinical and scientific gap, leaving youth with ADHD and co-occurring CDS at risk for experiencing negative immediate and long-term outcomes. In considering intervention approaches, mindfulness meditation involves regular practice to catch oneself when the mind wanders, and may thus an ideal intervention for youth with CDS. However, mindfulness interventions, including the Mindful Awareness Practices (MAPs) for ADHD, have never been tested in adolescents with ADHD and co-occurring CDS specifically. This study will recruit up to 15 adolescents with ADHD and co-occurring CDS symptoms to enroll in an open trial of MAPs to evaluate its feasibility, acceptability, and preliminary efficacy. Findings will provide key pilot data regarding treatment of CDS in adolescents with ADHD.

研究设计

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

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Between 13 and 17 years of age at the first MAPs session.
  • •Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
  • •Meet full DSM-5 criteria for ADHD (per protocol).
  • •SCT Total score >85th percentile (T-score >60) on the Child and Adolescent Behavior Inventory (CABI) SCT Module.
  • •Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment.
  • •If applicable: If the adolescent is taking a medication for ADHD or another psychiatric disorder (e.g., anxiety, depression), the adolescent must be on a stable medication dose/schedule for at least one month, and families will also be asked to not change/add medications the adolescent takes during the intervention period.

排除标准

  • •Children who have participated in behavioral therapy treatment in the past year will be ineligible.
  • •Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded.
  • •Significant visual, hearing, or speech impairment not helped with corrective or assistive devices (e.g., glasses, hearing aids) per parent report or study staff judgment.

研究组 & 干预措施

Mindfulness Treatment

Experimental

This arm consists of the mindfulness treatment that will be administered to all participants in the single-arm open trial.

干预措施: Mindful Awareness Practices (MAPs) (Behavioral)

结局指标

主要结局

Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM)

时间窗: Immediately after the intervention

Mindfulness measured using the adolescent-completed Child and Adolescent Mindfulness Measure (CAMM). Scores range from 0 to 40 (higher = worse).

次要结局

  • Change in mind wandering: Mind-Wandering Questionnaire (MWQ)(Immediately after the intervention)
  • Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)(Immediately after the intervention)
  • Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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