A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities (LEV-G)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Completion rate participants
研究概览
简要总结
Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.
详细描述
Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden.
Study 1: The feasibility trial investigates the following questions:
Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.
Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.
Do the intervention lead to adverse events? To what extent were individual goals met?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both adults with and without disabilities recruited from different healthcare contexts.
排除标准
- •Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
- •Insufficient command of the Swedish language/ unable to understand the content.
- •Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).
研究组 & 干预措施
Lev-g (group intervention)
Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others. There is no control condition. Only one arm to test feasibility.
干预措施: Lev-g (Behavioral)
结局指标
主要结局
Completion rate participants
时间窗: within 3-4 months
How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 3 out of 4 session)
次要结局
- Level of treatment credibility healthcare workers(Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months)I.e within 6 weeks)
- Treatment satisfaction participants (the three sessions)(Directly after completing the last treatment module in LEV (approximately at 3-4 weeks from baseline)])
- Treatment satisfaction healthcare workers (individual sessions)(After completing the first session in Lev. An average of 3-4 months from baseline)
- To what extent were individual goals met?(Directly after completing the booster session module in LEV (approximately at 3-4 months))
- Treatment satisfaction participants (individual sessions)(After completing the booster session in Lev. An average of 3-4 month from baseline)
- Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants(Directly after completing the booster session in LEV (approximately at 3-4 month from baseline)])
- Well-being before and after the intervention measures by The Evaluation Questionnaire(Directly after completing the booster session module in LEV (approximately at 3-4 months))
- Do Lev lead to healthier habits?(Before and after taking part in Lev (after is after the third, 3-4 weeks, as wells as after the booster session, 3-4 month))
- Level of treatment credibility participants(Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months). I.e within 6 weeks)
- Treatment satisfaction participants (the whole intervention including the booster session)(Directly after completing the last treatment module in LEV (approximately at 3-4 month from baseline)])
- Adverse events after the intervention(During the intervention up to week approximately 3-4 months)
- Self-efficacy for promoting health behaviors for their children(Directly after completing the booster session in LEV (approximately at 3-4 month))
- Treatment satisfaction participants (individual sessions)(After completing the first session in Lev. An average of 1-2 weeks from baseline)
- Treatment satisfaction participants (individual sessions)(After completing the second session in Lev. An average of 2-3 weeks from baseline)
- Treatment satisfaction participants (individual sessions)(After completing the third session in Lev. An average of 3-4 weeks from baseline)
- Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants(Directly after completing the third session in LEV (approximately at 3-4 weeks from baseline)])
- Treatment satisfaction healthcare workers (individual sessions)(After completing the first session in Lev. An average of 1-2 weeks from baseline)
- Treatment satisfaction healthcare workers (individual sessions)(After completing the first session in Lev. An average of 2-3 weeks from baseline)
- Treatment satisfaction healthcare workers (individual sessions)(After completing the first session in Lev. An average of 3-4 weeks from baseline)
- Well-being before and after the intervention measures by The Evaluation Questionnaire(Directly after completing the third treatment module in LEV (approximately at 3-4 weeks))
- To what extent were individual goals met?(Directly after completing the third treatment module in LEV (approximately at 3-4 weeks))
- Self-efficacy for promoting health behaviors for their children(Directly after completing the third session in LEV (approximately at 3-4 weeks))
研究者
Douglas Sjowall
PhD, Associate professor
Region Stockholm