Prevention of Unwanted Pregnancy and a Path to Informed Choice Among Young People With Intellectual Disability- a RCT, Intervention With Conversational Support and Real-Care-Baby Simulator
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Infant Simulator Attitude Scale (ISA)
研究概览
简要总结
This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.
详细描述
Background: There is limited knowledge about how young people with ID can be facilitated in their process of deciding about parenthood. A feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with ID in order to provide them with further insights about parenthood. Methods: Randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. Intervention includes thirteen educational lessons and a three-day and night caring-session with the RCB simulator. Intervention will be given 1-2 lessons/week during 8-14 weeks. Data will be collected with questionnaires and interviews before and after intervention. In control group: Before and after waiting-list time and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researchers are outcome assessors, independent from the intervention.
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students with mild or moderate ID with informed consent can be included
- •Understand and respond to a questionnaire
排除标准
- •- Students with severe ID
结局指标
主要结局
Infant Simulator Attitude Scale (ISA)
时间窗: Change from baseline after 13 weeks
The original ISA consists of 38 items of which most are statements with four response alternatives ranging from strongly agree to strongly disagree. It was translated to Swedish and to the cognitive level of students with intellectual disability. Statements were changed into questions and one response alternative "I do not know" was added. The items related to sexual activity and to contraception were omitted since it was not the focus of the intervention and also to ease the all over burden of lengthy questionnaires for the students.
次要结局
- General Self-Efficacy Scale (S-GSE)(Change from baseline after 13 weeks)
- Data extracted from Real Care Baby simulator(Change from baseline after three days and nights)