Evaluation of a Treatment Program Based on Psychoeducation of Parents of Children and Adolescents With Fetal Alcohol Spectrum Disorder (FASD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The Children's Global Assessment Scale (CGAS)
研究概览
简要总结
By longitudinal, prospective research in children and adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their parents to explore the beneficial effects of participating in a standardized intervention program in order to treat and reduce the consequences of early brain damage. By using elements from international programs based on psychoeducation and parent training, the investigators aim to help parents to better understand and respond to the neurodevelopmental disabilities of their children, and thereby improving behavioral problems and self-regulation deficits.
详细描述
The main aim of this research project is to evaluate the effects of a standardized intervention program for parents and professionals working with children and adolescents with FASD. Focus will be on care-persons' knowledge and skills and psychoeducation with regard to improved handling of behavioral problems and deficits in self-regulation due to FASD.
To achieve this aim objectives will be:
- to collect and analyse data on family empowerment, parenting skills and stress before and after participation in the intervention program.
- to collect and analyse data on the child's behavior and deficits in self-regulation before and after participation in the intervention program.
- to collect and analyse data on professionals' knowledge of FASD before and after participation in the intervention program.
The current study hypothesizes that caregivers who understand and view their children's behavior from a neurodevelopmental perspective are more likely to feel competence, use antecedent strategies, and thereby reduce child problem behavior and improve functional outcome (Fig. 2). The investigators hypothesize that participation in this program will improve parental empowerment and child self-regulation and behavior compared with baseline assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children and adolescents (age 2,5-18 years) referred to the Regional Competence Centre for children with prenatal alcohol exposure in Arendal, Norway will be invited to participate in the current research project.
- •Inclusion criteria:
- •Valid information about alcohol exposure in fetal life. Exceptions to this inclusion criterion are children who have been adopted and with dysmorphic features that are consistent with full Fetal Alcohol Syndrome.
排除标准
- •Children with known genetic syndromes, progressive brain and neuromuscular diseases or major sensory defects (blindness or deafness).
结局指标
主要结局
The Children's Global Assessment Scale (CGAS)
时间窗: up to 10 months
To evaluate effects of the intervention program well-known standardized, validated measures will be used. Primary outcome measure for the child will be The Children's Global Assessment Scale, which is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. The scale targets the number of behavioral problems and the frequency of their occurrence.The child or young person is given a single score between 1 and 100. Higher score means better functioning.
The Family Empowerment Scale (FES)
时间窗: up to 10 months
Primary outcome measure for parents will be The Family Empowerment Scale to evaluate the magnitude of empowerment in the parent-child system. FES is a 34-item rating scale where the participants rate each item on a 5-point Likert-type rating scale. Scores will range between 34 and 170 points. Increasing scores indicate a positive significance regarding family empowerment.
次要结局
- The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)(up to 10 months)
- The Parenting Stress Index (PSI)(up to 10 months)
- The Eyberg Child Behavior Inventory (ECBI)(up to 10 months)
- The Social Responsiveness Scale, Second Edition (SRS-2)(up to 10 months)