Evaluation of a Norwegian Model of an Intensive Habilitation Program for Young Children With Early Brain Damage - a Multicentre Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Change in Family Empowerment Scale (FES)
研究概览
简要总结
By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.
详细描述
Evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. As intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. This research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. In this randomized controlled trial (RCT) 90 children will be divided into an intervention group participating in a Norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. Between-group analyses will then be performed. Due to a stepped wedge design, the control participants will then be offered training in year two of participation. Within-group analysis of results before and after training will then be performed for all participants. Standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. Intensive training groups will be offered in all Health Regions in Norway and if successful be implemented as standard clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded evaluation by independent researchers at baseline, at 12 months and at 24 months.
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2 - 6 years at the start of the program
- •a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V),
- •being able to participate in group sessions
- •having parents who want to take an active part in their child's training
- •least one of the parents must speak fluent Norwegian or English.
排除标准
- •children with progressive disorders
- •co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.
研究组 & 干预措施
Control group
Half of the study participants will be randomized to "treatment as usual" the first year of program, then offered the intensive program during the second year ("stepped wedge design").
干预措施: Habilitation as usual (Other)
Intervention group
Half of the study participants will be randomized to the intensive habilitation program the first year of program. The second year of program this group of participants will be offered habilitation "as usual".
干预措施: Program Intensified Habilitation (Other)
Intervention group
Half of the study participants will be randomized to the intensive habilitation program the first year of program. The second year of program this group of participants will be offered habilitation "as usual".
干预措施: Habilitation as usual (Other)
Control group
Half of the study participants will be randomized to "treatment as usual" the first year of program, then offered the intensive program during the second year ("stepped wedge design").
干预措施: Program Intensified Habilitation (Other)
结局指标
主要结局
Change in Family Empowerment Scale (FES)
时间窗: Change from baseline measure at12 months and after 24 months
Primary evaluation measure for the parents
Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
时间窗: Change from baseline measure at 12 months and after 24 months
Primary evaluation measure for the child
次要结局
- Change in Gross motor function measure (GMFM-88)(Change from baseline measure at 12 months and after 24 months)
- Change in Parenting Stress Index (PSI)(Change from baseline measure at 12 months and after 24 months)
研究者
Jon Skranes
Professor dr med
Sorlandet Hospital HF