Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- ADHD Symptoms
研究概览
简要总结
The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention.
The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Legal guardian and primary caregiver of a child aged 36-71 months
- •Legal guardian or primary caregiver is age 16 years or older
- •Child receives pediatric care at Boston Medical Center or at one of the participating affiliated clinics
- •Able to understand informed consent procedures in English or Spanish
- •Participant has a child aged 36-71 months with an ADHD diagnosis, OR one elevated total or subscale score at the 80th percentile on the ADHD-Rating Scale-IV Preschool Version. 80th percentile cut-offs on the ADHD-Rating Scale-IV Preschool Version are as follows:
- •For male children, a total score ≥ 25 OR subscale score (inattention and/or hyperactivity) ≥ 12
- •For female children, a total score ≥ 13 OR subscale score (inattention and/or hyperactivity) ≥ 6 for female children
排除标准
- •There are no specific exclusion criteria for this study
结局指标
主要结局
ADHD Symptoms
时间窗: Baseline, 3 months, 6 months, and 12 months
ADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.
Total Resources Enrolled (Parent Report)
时间窗: Baseline, 3 months, 6 months, 12 months
Resource access was measured based on a parent report checklist of resources enrolled. The checklist was based on the Child HealthWatch Survey and modeled after data collected for the clinical trial testing the original social determinants intervention on which this intervention is based. The checklist included 18 resources that families could be enrolled in (for example - healthcare services, mental health care, special education, food benefits, housing assistance, etc), and asked parents to indicate which resources they were enrolled in. The end result is a count between 0 and 18 representing how many resources their family was enrolled in. Higher numbers indicate higher number of resources enrolled, whereas lower numbers indicate lower number of resources enrolled.
次要结局
- Parental Depression(baseline, 3 months, 6 months, 12 months)
- Parental Attention-deficit/Hyperactivity Disorder (ADHD)(baseline, 3 months, 6 months, 12 months)
- Parenting Stress(baseline, 3 months, 6 months, 12 months)
- PRE-CARE Feasibility and Acceptability Questionnaire(3 months)
- Child Psychiatric Symptoms(Baseline, 6 months, 12 months)
- Global Perceived Stress(baseline, 3 months, 6 months, 12 months)
研究者
Andrea Spencer
Vice Chair for Research
Ann & Robert H Lurie Children's Hospital of Chicago