Addressing Community Violence-related Traumatic Stress Symptoms in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit.
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of the Child and Family Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in producing significant and sustained reduction in PTSS among assault injured youth.
详细描述
Interventions to target modifiable risk and protective factors during the early post-trauma period may promote recovery and reduce posttraumatic stress symptoms (PTSS) following violent injury by facilitating cognitive and emotional processing of trauma reactions, increasing coping capacity, and providing emotional support.
Investigators seek to evaluate the effectiveness of the Child and Family Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in producing significant and sustained reduction in PTSS among assault injured youth.
Participants will be recruited from Children's Hospital of Philadelphia (CHOP) emergency department (ED) or Trauma Unit following interpersonal assault. Investigators seek to enroll 110 participants from CHOP. Participants must reside in Philadelphia County with a caregiver for at least the last six months, be 8 to 18 years of age (inclusive), have been received for an injury resulting from a qualifying interpersonal assault, and both child and caregiver must be able to speak English. Youth must have a Child Post-traumatic stress disorder (PTSD) Symptom Scale (CPSS) score > or = 11 during study screening.The Child and Family Traumatic Stress Intervention (CFTSI) is the study intervention. The primary outcome measure is youth-reported PTSS at 4 and 10 months.
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
Only the study coordinator and VIP staff members will be aware of a participant's randomization assignment. The study research assistants (RAs), who will be responsible for administering baseline, 4-month, and 10-month assessments will be blinded to the participant's study condition throughout the duration of the study.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for youth participants
- •Males or females age 8 to 18 years (inclusive)
- •Received treatment in the CHOP ED or trauma unit for an injury resulting from a qualifying interpersonal assault
- •Child must be able to speak English well enough to participate in study activities
- •Child must reside in Philadelphia County (191xx zip code)
- •Identifies a consistent caregiver for at least the past 6 months. This may include a parent, legal guardian, or another adult (e.g. grandparent, adult sibling, aunt/uncle, etc.).
- •Child PTSD Symptom Scale (CPSS) score > or = 11 in ED or on screening telephone call
- •Parental/guardian permission (informed consent) and child assent
- •Inclusion criteria for adult participants
- •Parent, legal guardian, or other caregiver of an eligible youth participant. Other caregivers may include non-legal guardians who meet all other study eligibility requirements and have approval of the participating child's parent/legal guardian to participate in study activities.
- •Adult must be able to speak English well enough to participate in study activities
- •Adult is youth's consistent caregiver for at least the past 6 months
- •Provide permission (informed consent) to participate in study activities. When a caregiver who is a non-legal guardian is identified to be primary caregiver and meet all other eligibility requirements, parental consent will be obtained for child participation in addition to non-legal guardian consent for self-participation.
排除标准
- •Exclusion criteria for youth participants
- •Age younger than 8 or older than 18 years
- •Youth who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
- •Youth hospitalized for greater than 14 days (unable to achieve timely study enrollment)
- •No long-term (< 6 months) caregiver
- •Index injury in the ED due to family violence (assaulted by a parent, sibling, or other family/household member), sexual assault, or fights with police, security, or school personnel
- •In residential placement at time of ED visit
- •Parent or legal guardian unable to provide consent for youth participation.
- •Exclusion criteria for adult participants
- •Not a primary or consistent caregiver for eligible youth for at least 6 months
- •Adult who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
- •Unable or unwilling to participate in CFTSI
结局指标
主要结局
Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit.
时间窗: 4 months
Assesses the severity of posttraumatic stress symptoms in youth ages 8 to 18 years old. Items correspond to DSM-5 PTSD symptom criteria. Symptom items are rated on a Likert-type scale (0-1-2-3-4) corresponding to "not at all" to "6 or more times a week/almost always." The CPSS yields a symptom severity score (sum of responses) and can be scored for possible PTSD diagnosis. Possible CPSS-5 scores range from 0 to 80. Based on the current evidence regarding screening for PTSD risk, we will employ a screening cut-off (greater than or equal to 11) on the summed CPSS severity score from 20 symptom items, indicating moderate PTSS.
次要结局
- Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit(4 months)
- Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit(10 months)
- Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit.(10 months)
- Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit(4 months)
- Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit(10 months)
- Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit(4 months)
- Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 10 months post-ED visit(10 months)