Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) for Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Emotion Dysregulation
研究概览
简要总结
This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program.
Both treatments are eight 90 minute sessions.
The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent between the ages of 13-17 years
- •Pre-existing diagnosis of ADHD in medical record
- •Seeking treatment at the Duke ADHD Program
排除标准
- •Psychiatric comorbidity that interferes with treating ADHD as the presenting concern per the study team.
- •Other concerns besides ADHD that would interfere with study participation according to the study team.
结局指标
主要结局
Emotion Dysregulation
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using Difficulties in Emotion Regulation Scale \[DERS\]: self and parent reports from pre-and post-treatment questionnaires. Each item on the DERS is rated using a 5-point Likert scale, with higher scores indicating greater difficulties with emotional regulation.
Trait Mindfulness
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Five Facet Mindfulness Questionnaire \[FFMQ\]: self report given during the pre-and post-treatment questionnaires. Each item on the FFMQ is rated using a 5-point Likert scale, with a higher total score indicating greater mindfulness.
Functional Impairment
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Impairment Rating Scale \[IRS\]: self and parent reports from the pre-and post-treatment questionnaires. Each item rated 0-6; total or mean scores vary by scoring method, with higher scores indicating greater functional impairment.
Executive Functioning
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using Behavior Rating Inventory of Executive Functioning \[BRIEF-2\]: parent report from pre-and post-treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.
Organizational Skills
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Behavior Rating Inventory of Executive Functioning (BRIEF-2): parent report given during the pre- and post- treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.
ADHD symptoms
时间窗: From enrollment to the end of treatment at 8 weeks
Measured using the Conners 3 self and parent reports from the pre- and post- treatment questionnaires. Participants will rate several statements using a scale ranging from 0 to 3 (from Not True at All to Very Much True). Higher scores indicate more behavioral, emotional, or ADHD-related concerns.
Functional Impairment
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Impairment Rating Scale \[IRS\]: self and parent reports from the pre-and post-treatment questionnaires. Each item rated 0-6; total or mean scores vary by scoring method, with higher scores indicating greater functional impairment.
Executive Functioning
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using Behavior Rating Inventory of Executive Functioning \[BRIEF-2\]: parent report from pre-and post-treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.
Emotion Dysregulation
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using Difficulties in Emotion Regulation Scale \[DERS\]: self and parent reports from pre-and post-treatment questionnaires. Each item on the DERS is rated using a 5-point Likert scale, with higher scores indicating greater difficulties with emotional regulation.
Trait Mindfulness
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Five Facet Mindfulness Questionnaire \[FFMQ\]: self report given during the pre-and post-treatment questionnaires. Each item on the FFMQ is rated using a 5-point Likert scale, with a higher total score indicating greater mindfulness.
Organizational Skills
时间窗: From enrollment to the end of treatment at 8 weeks.
Measured using the Behavior Rating Inventory of Executive Functioning (BRIEF-2): parent report given during the pre- and post- treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.
次要结局
未报告次要终点