Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child behavior problems and improving parenting capacity and skills at 4 primary care clinics in Philadelphia.
详细描述
Child behavioral concerns are common among families served by The Children's Hospital of Philadelphia (CHOP) urban primary care centers. To address this, we developed Child Adult Relationship Enhancement Model in Primary Care Parenting Program (PriCARE), a scaled down version of Parent Child Interaction Therapy designed for urban primary care clinics. The objectives of this study are to 1) evaluate the efficacy of the modified PriCARE to decrease child behavior problems and improve parenting capacity and skills and 2) understand parents' perceptions of the efficacy of PriCARE and strategies for improving its implementation and dissemination. We will perform a randomized controlled trial (RCT) of the effectiveness of the modified PriCARE on decreasing child behavior problems and improving positive parenting among 2- to 6-year-old children with behavior problems and their parents at CHOP's urban Primary Care Centers. We intend to randomize 120 child-parent pairs (240 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and 60 child-parent pairs (120 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of 180 child-parent pairs (360 subjects). All child-parent pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child behavior and parenting style will be measured at baseline (time 1), at 6-19 weeks (time 2), and at 14-27 weeks (time 3).
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)
盲法说明
The study team member who will administer the follow-up study interviews will remain blinded to the group status throughout the duration of the study.
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
- 是
入选标准
- •Parent is 18 years or older
- •Parent is English speaking
- •Child is 2-6 years old
- •Parent reports that child has a behavior problem
- •Child attends CHOP Urban Primary Care Center 6) 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 ADHD)
研究组 & 干预措施
Immediate PriCARE
Parent-child dyads assigned to the immediate PriCARE group will receive the PriCARE intervention as soon as possible plus usual treatment. The intervention will last approximately 6-8 weeks. Each group will have approximately 4-13 participants and 2 facilitators and will meet 6 times for 1-2 hours per session. Parents are expected to practice the skills they learn with their children between sessions.
干预措施: PriCARE (Behavioral)
Delayed PriCARE
The delayed PriCARE group will not receive the PriCARE intervention until after their data collection for this study is complete (in 3-6 months). In addition, they will be immediately offered usual treatment. 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.
结局指标
主要结局
Change in Eyberg Child Behavior Inventory (ECBI) score between baseline and time 3.
时间窗: baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3)
The primary objective of this study is to determine if the modified PriCARE program decreases the intensity and frequency of behavior problems in 2- to 6-year-old children as measured by the change in ECBI score after 3-7 months compared to usual treatment for child behavior problems at CHOP's South Philadelphia Primary Care Center or Karabots Pediatric Care Center. As sub-analyses, we will determine 1) the impact of caregiver depression (as measured by the Brief Symptom Inventory, BSI) on the efficacy of PriCARE intervention to decrease behavioral problems and 2) the impact of the number of PriCARE sessions attended on the efficacy of the PriCARE intervention to decrease behavioral problems.
次要结局
- Change in Adult Adolescent Parenting Inventory-2 (AAPI-2) score between baseline and time 3(baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3))
- Change in The Keys to Interactive Parenting Scale (KIPS) score between baseline and time 3(baseline (time 1) and 14-27 weeks (time 3))
- Conceptual model of facilitators and barriers to participation in behavioral interventions in primary care as well as the strengths and weaknesses of the PriCARE program(6-27 weeks)
- Change in Parenting Stress Index (PSI) score between baseline and time 3(baseline (time 1), 6-19 weeks (time 2), and 14-27 weeks (time 3))
- Association between the Therapeutic Attitude Inventory (TAI) score and the change in ECBI score from baseline to time 2 and 3 in the immediate PriCARE group.(14-27 weeks (time 3))