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临床试验/NCT02857673
NCT02857673已完成不适用

A Medical Home-Based Intervention to Prevent Child Neglect in High-Risk Families

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Adherence to recommended medical care

研究概览

简要总结

Child maltreatment, particularly neglect, disproportionally affects low-income children with special health care needs (CSHCN) and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. Child Abuse Prevention Problem Solving (CAPPS), a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children. This study is a multi-center randomized controlled efficacy trial of CAPPS to determine the impact on child neglect, adherence to recommended medical care, and family stressors and strengths.

详细描述

Child maltreatment, particularly neglect, disproportionally affects low-income CSHCN and has serious short and long-term consequences. Currently, few replicable, evidence-based preventive services exist for such families, particularly within the context of the patient-centered medical home. CAPPS, a targeted problem solving intervention that addresses key risk and protective factors for child neglect, has the potential to improve key parenting skills and overall wellbeing, ultimately improving outcomes for high-risk children.

This is a multi-center randomized controlled efficacy trial of Child Abuse Prevention Problem Solving (CAPPS), a targeted intervention designed to address specific stressors faced by low-income parents of children with special health care needs (CSHCN) and to enhance family strengths previously been shown to reduce the risk of maltreatment. The study will enroll 250 parents of CSHCN who receive primary care in a network of urban patient-centered medical homes. The specific research aims are to 1: Decrease referrals to child protective services for neglect and increase adherence to recommended medical care; and 2: Decrease perceived social isolation, difficulty navigating complex services, and caregiver burden and enhance family strengths, including parental resilience, social connections, access to support in times of need, and knowledge of parenting and child development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Primary caregiver of a child under age 7 with a physical, emotional, or behavioral health condition
  • •Child on Medicaid
  • •Fluent in English or Spanish

排除标准

  • •Prior history of substantiated child maltreatment
  • •Prior history of report to child protective services for suspected child maltreatment
  • •Parent cognitively limited

研究组 & 干预措施

Intervention Group

Experimental

The intervention group will receive Child Abuse Prevention Problem Solving (CAPPS), a one-on-one, workbook-based intervention of six sessions, each lasting approximately 30-60 minutes. CAPPS is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. Sessions will be delivered at the medical home by bachelor level providers, whose availability and level of training mimic those of existing medical home care coordinators.

干预措施: Child Abuse Prevention Problem Solving (Behavioral)

Active Control Group

Active Comparator

Parents in both study groups will receive the standard medical and social work services offered in the patient-centered medical homes where their children receive care. In addition, to account for potential surveillance bias, families in the control group will be contacted by a member of the study team six times over 12 weeks, approximating the frequency of contact that the intervention group receives from the CAPPS providers. The study team member will not be trained in CAPPS and will adhere to a case management model consistent with resources available in the medical home, checking in with control families and offering to help identify existing clinic and community resources as needed.

干预措施: Active Control Group (Behavioral)

结局指标

主要结局

Adherence to recommended medical care

时间窗: Up to 12 months after enrollment in study

Adherence will be evaluated by chart review to determine a composite measure that includes numbers of medical visits attended, hospitalizations, missed appointments, delayed or missed prescriptions fills, and receiving recommended immunizations.

Referral to Child Protective Services for neglect

时间窗: Up to 12 months after enrollment in study

This will be determined using chart review and parent report.

次要结局

  • Parental resilience and social connections - RSES(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - PM(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - PSI(Up to 12 months after enrollment in study)
  • Access to concrete support(Up to 12 months after enrollment in study)
  • Knowledge of parenting skills, child development - PS(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - CHIP(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - SAS-SR(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - PSS(Up to 12 months after enrollment in study)
  • Knowledge of parenting skills, child development - CTSPC(Up to 12 months after enrollment in study)
  • Parental resilience and social connections - MOS-SS(Up to 12 months after enrollment in study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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