Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Change from baseline in child exposure to trauma and maltreatment to end-of-treatment and at 6-month follow-up (Child Adverse Childhood Experiences Screener)
研究概览
简要总结
The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships.
We hypothesize that compared to usual care, GABI will be associated with improved child, parent and parent-child outcomes.
详细描述
Child abuse and neglect ("maltreatment") pose enormous short- and long-term risks to children. Yet despite the critical importance of the U.S. Department of Health and Human Services, Maternal and Child Health Bureau's goal "to reduce fatal and non-fatal child maltreatment," non-empirically supported parenting skills classes remain child welfare agencies' standard approach to meeting this goal.
The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships.
Seventy families with children aged 2-36 months who are referred for parenting help will be randomly assigned to either GABI or "treatment as usual" that consists of parents-only parenting skills classes. Treatment will be offered for up to 6 months. Both groups will be assessed at baseline, end of treatment and at 6 months follow up.
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)
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents with children age 0-36 months
- •Parent(s) is/are biological parent of child (mother or father)
- •Parent(s) has/have custody of their child even if he/she/they have lost custody of previous children
- •Risk of maltreatment from referral source or intake interview, including parent's own childhood adversity, parent's current exposure to relationship violence, history of parental substance abuse or history of parental incarceration
- •If history of substance abuse, enrolled in treatment program
- •Willing to sign informed consent
排除标准
- •Parent is unable to provide informed consent due to cognitive impairment
- •Parent not fluent in English
- •Child has diagnosis of an autistic spectrum disorder or severe cognitive delay
研究组 & 干预措施
Group Attachment Based Intervention (GABI)
干预措施: Group Attachment Based Intervention (GABI) (Behavioral)
Systematic Training for Effective Parenting (STEP)
干预措施: Systematic Training for Effective Parenting (STEP) (Behavioral)
结局指标
主要结局
Change from baseline in child exposure to trauma and maltreatment to end-of-treatment and at 6-month follow-up (Child Adverse Childhood Experiences Screener)
时间窗: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up
次要结局
- Parent mental health (Symptoms Checklist-90)(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up)
- Parenting stress (Parenting Stress Index)(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up)
- Child social-emotional development (Ages and Stages Questionnaire)(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up)
- Parent social support (Interpersonal Support Evaluation List)(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up)
- Child cognitive development (Bayley III Screening Test)(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up)
- Child-parent attachment (Strange Situation Procedure) and Free -Play Observation coded with Coding Interactive Behavior (CIB) dimensions(Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up)
研究者
Karen Bonuck
Karen A. Bonuck, PhD (Professor)
Albert Einstein College of Medicine