Improving Child Behavior Problems in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
研究概览
简要总结
The purpose of this research study is to learn whether or not a brief parenting program called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help improve behavior problems in children who are 2-6 years old.
详细描述
The study will be a randomized controlled trial (RCT) of the CARE intervention. The study will include 2-6 year old children who receive their primary care at the Children's Hospital of Philadelphia, South Philadelphia Primary Care clinic and whose caregiver and/or doctor has concern about a behavior problem in the child. The caregivers will also be subjects in the study.
Child-caregiver pairs who agree to be in the study will be randomly assigned to receive the CARE training immediately or in 3-4 months.
The CARE intervention will last 6 weeks and child behavior and parenting will be measured at baseline, 6-8 weeks, and 14-18 weeks. Investigators will also measure parent satisfaction with the CARE intervention.
- Child Adult Relationship Enhancement (CARE) is a group parent training program.
- The goals of the program are to teach parents skills that help their children successfully reach developmental milestones while increasing positive behaviors.
- The program also was designed to help parents manage and decrease negative child behaviors.
- Each training will be led by 2 therapists and 4-10 parents will attend the CARE program together.
- Children do not attend the training but parents are encouraged to practice the skills learned at CARE between the sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver is 18 years or older
- •Caregiver is English speaking
- •Child is 2-6 years old
- •Caregiver reports that child has a behavior problem
- •Child attends CHOP South Philadelphia Primary Care for primary care
- •Parental/guardian permission is provided (informed consent)
排除标准
- •Child has a cognitive age less than 2 years old as determined by the referring clinician
- •Child is already receiving behavioral health therapy or medication (other than medication for Attention Deficit Hyperactivity Disorder)
研究组 & 干预措施
Delayed CARE
40 child-caregiver pairs will be randomized to usual treatment plus delayed CARE (control). Under usual treatment, patients will be referred to a behavioral health specialist at the discretion of their pediatrician and the office social worker for additional diagnosis and treatment and/or provided with a 1-2 page informational handout on child behavior problems from the CHOP patient care manual. Following the final interview (3-4 months after enrollment for each subject) all participants randomized to the control arm (usual treatment plus delayed CARE) will receive the CARE training, if desired.
Immediate CARE
40 child-caregiver pairs will be randomized to usual treatment plus immediate CARE. The trainings are administered to groups of 4-10 caregivers at a time and are led by two mental health providers trained in the CARE curriculum. The children do not attend the training; however, caregivers are expected to practice the skills that they learn in CARE with their child between sessions. The curriculum involves 6 sessions over 6-8 weeks. Each session will be 1-2 hours.
干预措施: Immediate CARE (Behavioral)
结局指标
主要结局
Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)
时间窗: Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.
Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.
次要结局
- Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)(Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.)