Treating ADHD Parents and Their Infants Via Telehealth: Developing an Early Parenting Intervention Using a Deployment-focused Intervention Design
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
Using stakeholder feedback (i.e., behavioral health providers & caregivers), the goal of this study is to develop a behavioral parenting program that focuses on both parent mental health and parenting for parents of toddlers (12-35 months old). Using a deployment focused intervention model, this study will : (1) develop an early parenting intervention for parents of at-risk toddlers which integrates a focus on parent mental health with evidence-based behavioral parenting strategies, and (2) examine context-specific factors related to the intervention, including feasibility and acceptability to design a more practice-ready intervention.
详细描述
Very early identification of children and families at risk of developing psychopathology can lead to early prevention/intervention to address challenging behaviors before they become more severe, likely reducing the length and cost of interventions. Using the information provided by the stakeholder group, the current study will implement in an open trial the early parenting intervention for ADHD parents of at-risk toddlers (n = 10 families) via telehealth by primary care co-located psychologists. Investigators will examine implementation factors including fidelity, feasibility (utility, adherence) and acceptability (facilitators, barriers) of the early parenting intervention. Quantitative data (adherence checklists, symptom measures, observational parenting measures) will be used to assess the extent to which primary care providers and office staff adhere to the intervention manual, as well as changes in toddler and parent behavior resulting from the intervention. Qualitative data (interviews/ focus groups) with stakeholders (behavioral health providers and caregivers of toddlers) will inform a refined intervention model and assess perceptions of utility, fit, and satisfaction of the intervention components. This mixed-methods approach will offer the most comprehensive examination of an early parenting intervention model for parents of at-risk toddlers in a pediatric primary care setting.
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
- 12 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included in the stakeholder group, participants must work at a CNMC primary center or must be a parent with a toddler.
- •For inclusion to participate in the pilot intervention, a full-time guardian must, at the time of screening:
- •Sign informed consent online
- •Be between 21-55 years old (inclusive) and be English or Spanish-speaking
- •Meet full DSM-5 criteria for ADHD, any subtype as determined by the SCID-5
- •Have current CGI-S-ADHD rating ≥ 4 and < 7
- •Commit to the entire study
- •Be able to complete all study assessments virtually (i.e., they must have a device that connects to the internet with a camera)
- •Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent; and (b) if receiving an antidepressant medication, their medication is well-tolerated and has not changed within 30 days.
- •For inclusion to participate in the pilot intervention, toddlers must:
- •be between ages of 12 - 35 months at time of consent
- •score above the 75th percentile on the BITSEA problem scale
排除标准
- •Parents will be excluded on the basis of current bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring other immediate treatment.
结局指标
主要结局
Acceptability
时间窗: up to 12 weeks
Client Satisfaction Questionnaire (CSQ-8)- higher scores indicate more satisfaction
次要结局
未报告次要终点
研究者
Andrea Chronis-Tuscano
Professor
University of Maryland, College Park