Child-Adult Relationship Enhancement in Primary Care: Supporting Parents and Children
概览
- 阶段
- 不适用
- 干预措施
- PriCARE/CARIÑO
- 疾病 / 适应症
- Parent-Child Relations
- 发起方
- University of North Carolina, Chapel Hill
- 入组人数
- 1932
- 试验地点
- 4
- 主要终点
- Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
- 状态
- 招募中
- 最后更新
- 昨天
概览
简要总结
The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.
详细描述
The primary objective of this study is to evaluate the effectiveness of PriCARE/CARIÑO to reduce investigations of suspected Child Maltreatment (CM) by Child Protective Services (CPS), and CM risk as measured by the Brief Child Abuse Potential Inventory (BCAP). The secondary objectives of this study are to measure the impact of PriCARE/CARIÑO on: 1. Parent-reported child behavior problems as assessed by the Eyberg Child Behavior Inventory (ECBI). 2. The quality of the parent-child relationship as measured by the Dyadic Parent-Child Interaction Coding System (DPICS). 3. Parenting stress as measured by the Parenting Stress Index-Short From (PSI). 4. Harsh parenting as measured by Conflict Tactics Scales, Parent-Child version (CTS) and the Parenting Scale (PS) The investigators will perform a randomized controlled trial (RCT) of the effectiveness of the PriCARE/CARIÑO on objectives listed above among 2- to 6-year-old children and their parents at 3 Children's Hospital of Philadelphia (CHOP) Primary Care Centers and 10 pediatric clinics in North Carolina. The investigators intend to randomize 966 child-caregiver dyads (1932 subjects) to receive PriCARE/CARIÑO plus usual care (intervention group) and 966 child-parent dyads (1932 subjects) to receive usual care (control group). CM risk, parenting attitudes and skills, child behavior, and quality of the child-caregiver relationship will be measured at baseline and approximately 6-8 months after randomization for both the intervention and control groups. CPS investigations will be collected starting 4 months after randomization until the end of the study (up to 52 months).
研究者
入排标准
入选标准
- •Caregiver is age 18 years or older
- •Caregiver is English or Spanish Speaking
- •Caregiver is legal guardian of child subject
- •Caregiver provides informed consent
- •Caregiver is available to attend scheduled times of PriCARE/CARIÑO groups
- •Caregiver has cellular phone with text messaging capacity
- •Caregiver has appropriate technological tools and access to participate in virtual intervention
- •Child is between 18 months and 6 years old
- •Child receives care at participating primary care center
- •Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
排除标准
- •Caregiver or another caregiver in the household has previously participated in PriCARE/CARIÑO
- •Child has a cognitive functioning below 2-year-old level, as determined by the screening questions and/or the referring clinician
- •Child has a diagnosis of autism
- •Child is receiving individual behavioral health treatment or medication for a behavioral health problem
研究组 & 干预措施
PriCARE/CARIÑO plus Usual Care
Caregiver-child dyads assigned to the PriCARE/CARIÑO plus usual care group will receive the PriCARE/CARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions.
干预措施: PriCARE/CARIÑO
Usual care
Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects.
结局指标
主要结局
Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
时间窗: Baseline, 0 months (time 1) to 6-8 months after baseline (time 4)
Change in BCAP scores from time 1 to time 4 will be measured. BCAP, a 34-item survey, measures traits and parenting styles typical of known physical child abusers. Each item has a unweighted value based on if agree vs. disagree is chosen and then the values are summed. Child abuse risk scores range from 0-24 with higher scores indicating caregiver has traits similar to those of known child abusers and has a higher risk of abuse.
Child Protective Services Investigations from time 3 to time 5
时间窗: 4 month after baseline (time 3) up to 52 months after baseline (time 5)
The primary outcome variable is a binary indicator of whether or not the child experienced at least one investigation from Child Protective Services (CPS) during follow-up. Beginning 4 months after randomization, each child will be followed for a period of 12 to 48 months to document all CPS investigations of suspected child maltreatment. The length of the follow-up interval will depend on the dyad's time of enrollment in the study.
次要结局
- Change in the number of direct commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Scale (PS) total score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the number child's compliance with commands in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Scale (PS) Laxness subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Eyberg Child Behavior Inventory (ECBI) problem scale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Stress Index-Short Form (PSI) Parent-Child Dysfunctional Interaction subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Scale (PS) Over-Reactivity subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Scale (PS) Hostility subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Eyberg Child Behavior Inventory (ECBI) intensity scale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Stress Index-Short Form (PSI) total score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the number of child led play skills in the Dyadic Parent-Child Interaction Coding System (DPICS) from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the number of non-child led skill in Dyadic Parent-Child Interaction Coding System (DPICS) score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Stress Index-Short Form (PSI) Parental Distress subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Parenting Stress Index-Short Form (PSI) Difficult Child subscale score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))
- Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Weekly Discipline score from time 1 to time 4(Baseline, 0 months (time 1) to 6-8 months after baseline (time 4))