Standard Versus Culturally-Modified ADHD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
研究概览
简要总结
The current pilot study aims to close the existing gap in our knowledge about effective psychosocial treatments for Latino families by providing preliminary data regarding the acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators that will support a future R01. Specifically, the current pilot study is the first step in a larger program of research aimed at definitively determining if culturally-modified ADHD treatment outperforms standard treatment when examining engagement and acceptability outcomes, as well as symptomatology and parental functioning, and if so, which treatment modifications are necessary and for whom. The following study aims will be examined.
- Aim 1 is to explore if the culturally-modified treatment results in better engagement and acceptability outcomes (i.e., parental attendance, retention, engagement, and satisfaction) than standard treatment and to determine the strength of these effects.
- Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD symptomatology, as well as parental functioning (i.e., parenting stress and efficacy), to explore if the modified treatment results in similar or greater improvements than standard treatment, and to determine the strength of these effects.
- Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral and cognitive acculturation) that may explain the relationship between treatment type (i.e., standard versus culturally-modified) and outcomes and to determine the strength of these interactions.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must
- •Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment
- •Receive a primary diagnosis of ADHD
- •If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment
- •Participating parents must
- •Self-identify as Latino
- •Be fluent in Spanish
- •Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment
- •Have no immediate plans to pursue other treatment for their child's ADHD or to change their child's medication (if already medicated) over the next eight weeks
排除标准
- •Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder
研究组 & 干预措施
Standard ADHD parent training
8 sessions of evidence-based parent training plus school intervention
干预措施: Parent training (Behavioral)
Culturally-modified ADHD parent training
8 sessions of culturally-modified parent training plus school intervention
干预措施: Parent training (Behavioral)
结局指标
主要结局
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
时间窗: 8 weeks
Number of families who completed treatment (recorded by clinician)
Engagement in Treatment - Homework Completion (% of Completed Homework)
时间窗: 8 weeks
(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)
Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)
时间窗: 8 weeks
Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)
Engagement in Treatment - Sessions Attended
时间窗: 8 weeks
Number of sessions attended by each family (recorded by clinician)
次要结局
- Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)(Baseline to 8 weeks)
- Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)(8 weeks)
- Change in Parental Functioning (Maternal Parenting Stress)(8 weeks)
研究者
Alyson Gerdes
Associate Professor
Marquette University