Testing a Novel ADHD Engagement Intervention "START" to Improve Access to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning
研究概览
简要总结
The randomized control trial (RCT) study includes 2 aims; one being to test whether START increases access to treatment for ADHD. Investigators believe the intervention group will demonstrate improved treatment engagement and access to all treatments compared to controls. The second aim is to explore whether START leads to functional improvements across home, social and academic domains for the child and family. Investigators believe the intervention group will show better functioning including improved family and peer relationships and reduced parent stress compared to controls.
Before taking part in our study all participants will undergo a psychiatric evaluation. Eligible participants will be randomized to START while controls receive a pamphlet with ADHD information. Students and staff with related experience who are not mental health professionals will be trained to deliver START. START includes 6 modules, typically delivered over 6 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is greater than or equal to 6 years old and less than or equal to 12 years old
- •The child has a diagnosis of ADHD confirmed based on clinical psychiatric evaluation with an expert child psychiatrist on the study team (PI or Co-I)
- •The diagnosis of ADHD is either new (defined as made for the first time by the study psychiatrist OR made for the first time within the prior 3 months by a medical or mental health provider) OR the child has been previously diagnosed but untreated either since diagnosis or for at least the prior 12 months. "Untreated" is defined as having received no therapeutic, medication, or school accommodations specifically for ADHD.
- •They can understand and complete informed consent and study procedures in English.
- •Children who have received treatment for other psychiatric conditions may be included if the treatment was specifically for a condition other than ADHD, to be confirmed by the study psychiatrist at enrollment.
排除标准
- •Children with most comorbid (i.e., co-existing) psychiatric conditions with be included, but children with intellectual disability/cognitive impairment or psychotic symptoms will be excluded because these conditions would substantially change the focus of treatment
- •Children under 6 and over 12 will be excluded because the intervention was specifically designed for school age children in this age group. Developmental, adolescents and preschoolers are considerably different than school age children and may require a different approach for engaging them and their parents in ADHD care. Children under 6 with ADHD symptoms may not yet be diagnosed and may not have the same treatment access or options as children 6 and over. Adolescents over 12 are more independent and an intervention may need to be more focused on the adolescent than our current intervention which is primarily parent focused.
- •Children who were diagnosed over 3 months ago and already received treatment for ADHD will be excluded since our primary outcome is treatment engagement.
- •Because this is an intervention only available in English at this time, participants who are not able to complete study procedures in English will be excluded.
研究组 & 干预措施
Educational Brochure
Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).
START Intervention
Participants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.
干预措施: SupporT for ADHD and Related Treatment (Behavioral)
结局指标
主要结局
Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning
时间窗: 3 months
Vanderbilt ADHD Diagnostic Rating Scale (VADRS). 55-item, parent-report questionnaire that assesses symptoms of ADHD and comorbidities as well as functional impairment in multiple domains (academics, family and peer relationships).
Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization
时间窗: 3 months
Items from the National Survey of the Diagnosis and Treatment of ADHD and Tourette Syndrome (NS-DATA). Centers for Disease Control (CDC) survey used to evaluate treatment use among children with ADHD and Tourette syndrome.
次要结局
- Engagement Objectives(3 months)
- Attention-deficit/hyperactivity disorder (ADHD) Knowledge(3 months)
- Parenting Stress(3 months)
- Parent Perceived Stigma(3 months)
- Child Education(3 months)
- Parent ADHD Treatment Preferences(3 months)
- Parent Activation(3 months)
- Parent Self Stigma(3 months)
- ADHD Stages of Engagement Questionnaire(3 months)
- Family Relationships(3 months)
- Social Risk(3 months)
- ADHD School Services(3 month)
研究者
Andrea Spencer
Vice Chair for Research in Psychiatry
Ann & Robert H Lurie Children's Hospital of Chicago