Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With Fetal Alcohol Spectrum Disorder (FASD) or At-risk for FASD: A Randomized Controlled Field Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Attachment Classification
研究概览
简要总结
Study Summary: This study is being conducted in order to rigorously evaluate the real-world effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of Security (COS) Family Intervention Model (Marvin) in improving caregiving and child outcomes in families who have children with Fetal Alcohol Spectrum Disorder (FASD) or who are at-risk for FASD, as delivered under routine practice conditions.
Hypothesis: At post-test (after 36 sessions and 3-month follow-up), compared to a wait-list control group receiving standard services, the treatment group receiving COS will show greater improvement in caregiver behaviour, as well as child emotional and behavioural outcomes.
详细描述
See Arms and Intervention
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two criteria must be present for a family (caregiver-child dyad) to be included in the COS component of the FASD Outreach Program and its evaluation:
- •the child was exposed to alcohol prenatally and has been clinically evaluated using the Canadian FASD diagnostic guidelines as having Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), Alcohol Related Neurodevelopmental Disorder (ARND), or is considered "at risk" for FASD based on their confirmed history of prenatal alcohol exposure and clinical multidisciplinary assessment; and
- •evidence of disrupted caregiver behaviours or problems in the caregiver-child interaction as identified through a screening process consisting of clinical judgment and the SBSH procedure.
排除标准
- •children from foster families who have experienced more than 2 placements in the last six months,
- •children who have an Autism diagnosis,
- •children with a developmental quotient less than 50,
- •children with sensory impairments (hearing or sight impaired), and
- •children who are already involved in New Directions' 'Self Regulation Therapy Project'.
- •Children who have parents who are clinically depressed, whose parents have substance abuse or domestic violence issues, or whose parents display a narcissistic devaluation personality trait based on initial clinical evaluation, will also be excluded from study eligibility.
结局指标
主要结局
Attachment Classification
时间窗: Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)
Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.
次要结局
- The Parenting Scale (TPS)(Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup))
- The Strengths and Difficulties Questionnaire SDQ(Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup))
- The Parenting Stress Index (PSI)(Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup))
- The Depression Anxiety Stress Scale (DASS)(Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup))
研究者
Dr. Ana Hanlon-Dearman
Developmental Pediatrician
University of Manitoba