2/2 Treating Mothers With ADHD and Their Young Children Via Telehealth: A Hybrid Type I Effectiveness-Implementation Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 2
- 主要终点
- Change in child ADHD-related impairment
研究概览
简要总结
This study will compare the effectiveness of combined parental stimulant medication and behavioral parent training (BPT) versus BPT alone on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, time to child stimulant prescription (secondary child outcomes) and parental ADHD impairment, parental ADHD symptoms, parenting, and BPT engagement (parental outcomes/target mechanisms). This study will also assess the care delivery context and develop an implementation approach for treatment of families with a parent with ADHD and a child with elevated ADHD symptoms via telehealth in primary care sites providing pediatric care.
详细描述
Parental ADHD, present in 25-50% of families of children with ADHD and frequently untreated, interferes with effective parenting and predicts poor child developmental and behavioral treatment outcomes. Based on the literature and our own pilot data, the study will randomly assign parents with ADHD and their young at-risk children to one of two conditions: (1) stimulant medication for parents with ADHD followed by a child treatment strategy (CTS) beginning with behavioral parent training (BPT) with the added recommendation of child stimulant treatment if the child remains impaired or (2) a CTS without treatment for parental ADHD. The study will compare treatment effects on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, and time to child stimulant prescription (secondary child outcomes). The study will also examine target mechanisms including improvements in parental ADHD-related impairment and symptomatology (attention, impulsivity, emotional regulation), parenting skills, and BPT engagement, as well as treatment moderators (baseline parental ADHD severity, parental impairment, and parenting skills). Moreover, in an effort to develop a model of treatment that has potential for widespread dissemination while also reducing barriers to receiving care, the study will examine an implementation model involving parent ADHD screening in primary care followed by collaborative care delivered by co-located mental health providers via telehealth. Further, the investigators will develop an implementation plan and associated toolkit using a stakeholder participatory strategy to enhance the ability to move efficiently to adoption of this approach. In addition, the investigators will study the care delivery context, assessing procedures for and rates of screening and participation as well as staffing, workflow, provider- and patient-level acceptability, readiness, and feasibility of implementation approaches. This hybrid effectiveness-implementation project will be achieved via a collaborative R01 across 2 research sites in the US (N = 240 families), with 4-5 primary care partners at each site.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child Inclusion Criteria:
- •Be at least 3 years old and no more than 8 years old
- •ADHD medication naive or have not had an adequate trial of stimulant medications
- •Have ≥5 inactivity or ≥5 hyperactivity symptoms rated as 1 or 2 on the Vanderbilt
- •Have a CGI-S-ADHD rating ≥4 and <7
排除标准
- •Severe ADHD (CGI-S-ADHD score of greater than 6)
- •Parent Inclusion Criteria:
- •Be at least 21 years old and English-speaking
- •Meet full DSM-5 criteria for ADHD (any subtype)
- •Have findings on physical examination, laboratory studies, vital signs, and electrocardiogram judged to be normal for age with no contraindications for stimulant medication
- •Have pulse and blood pressure (BP) within 95% of age and gender mean
- •Women of childbearing potential agree to use a medically accepted contraception method consistently
- •Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent (i.e. Beck Depression Inventory (BDI)-II score of 2 or 3 to Q9 which assesses suicidal thoughts); and (b) if receiving an antidepressant medication, their medication is well-tolerated, has not changed within 30 days, and the prescribing physician approves of their participation in the study
- •Must have regular access to a computer or phone that can be used to deliver the behavioral parent training
- •Parent Exclusion Criteria:
- •History of allergic or other severe negative reactions to study medications
- •Substance abuse in the past 3 months, or a positive baseline urinary toxic screen that is not explained by a time-limited medical circumstance
- •Current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment
- •History of chronic/acute medical disorder for which stimulant therapy would be contraindicated (e.g., glaucoma, hypertension)
- •Stimulant medication for ADHD in the past 30 days
- •Is pregnant
研究组 & 干预措施
Parent Stimulant Medication + Child Treatment Strategy
Parent stimulant medication first followed by a child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired.
干预措施: Behavioral Parent Training (Behavioral)
Parent Stimulant Medication + Child Treatment Strategy
Parent stimulant medication first followed by a child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired.
干预措施: Extended release mixed amphetamine salts (MAS) (Drug)
Child Treatment Strategy
Child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired. In this arm, parents do not receive stimulant medication before behavioral parent training.
干预措施: Behavioral Parent Training (Behavioral)
结局指标
主要结局
Change in child ADHD-related impairment
时间窗: Baseline, 16 weeks, 36 weeks
Assessed using the Clinical Global Impressions (CGI) - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity scale. Minimum value = 1, maximum value = 7. Higher scores indicate worse outcomes.
Change in Child Impairment
时间窗: Up to 16 weeks post-randomization
Assessed using the Clinical Global Impressions (CGI) - Severity scale. Minimum value = 1, maximum value = 7. Higher scores indicate worse outcomes. The Child CGI outcome was collected for enrolled parent-child dyads. Community stakeholders and providers were not assessed for this outcome.
次要结局
未报告次要终点
研究者
Andrea Chronis-Tuscano
Professor
University of Maryland, College Park