A Randomised Controlled Trial of an Online Intervention to Prevent Anxiety in the Children of Anxious Parents
试验速览
- 阶段
- 不适用
- 入组人数
- 3,508
- 试验地点
- 2
- 主要终点
- Change in child anxiety
研究概览
简要总结
This is a randomised controlled trial of an intervention to reduce symptoms of anxiety in the children of anxious parents. Parents will participate in an online intervention which helps them develop a calm, consistent, behaviour management style. The parents will be randomised to the intervention or a control group with no intervention. The intervention itself will undergo a component analysis to determine whether some modules are more effective than others.
详细描述
The study is an online course (derived from an existing evidence-based face-to-face workshop designed and evaluated by the C.I) which aims to reduce symptoms of anxiety in the children of anxious parents. It is a learning tool to help parents to understand the basic processes involved in children's anxiety, to develop a calm, consistent, behaviour management style and to learn skills for responding to difficult emotion in their children.
The whole study takes place online, allowing the participants to sign up, run through some brief eligibility questions, read the study information and provide consent.
Once enrolled in the study, there is a series of baseline questionnaires. The participant also has the option to nominate someone who also knows their child well (e.g. a co-parent, a family member or close friend) to participate in the study with them and to complete a small number of questionnaires. This will help to give us a broader, more objective picture of the child, but is an optional part of the study. 48 hours later (to allow time for the participants to contact the co-respondent if they choose) the index participant will be randomised to one of two groups: either the intervention (the online course), or the control group where they do not receive the intervention.
Those in the intervention will be randomised to receive 8 out of 9 modules of the course, with a suggested time frame of one or two modules a week, each module taking about 30 minutes, with some home-practice tasks in-between.
Both the intervention group and the control group participants will be contacted again after 6 months to complete a set of follow-up questionnaires (similar to those completed at baseline). Depending on when each participant joins the trial, they may be contacted a third time towards the end of the life of the study, to complete another set of questionnaires,9-21 months after their first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a parent (any gender, adoptive/biological/step/foster/grandparent) aged 16+, of a child aged 2 to 11 years (inclusive). The index parent must have at least 50 days' contact with the index child per year and confirm that they see enough of the child to report on the child's current anxiety level.
- •Index parent must be a UK resident.
- •Self-report subjectively substantial levels of current or lifetime anxiety.
- •Able to commit to completion of measures at (up to) three time points even if allocated to the control arm.
排除标准
- 未提供
结局指标
主要结局
Change in child anxiety
时间窗: Baseline, 6 months, and up to 21 months.
Measured using the Spence Children's Anxiety Scale (SCAS-P and Preschool SCAS if the child is aged 6 or under). SCAS-P: Minimum 0 Maximum 114. A higher total score is indicative of higher level of child anxiety. T scores used to indicate clinical levels of anxiety however this is a screen not a diagnostic instrument. SCAS Preschool: Minimum 0 Maximum 112. A higher total indicates a higher level of pre-school child anxiety. A score of 1SD above the mean for a subscale or the total score indicates clinical investigated would be warranted.
次要结局
- Change in child wellbeing and health(Baseline, 6 months, and up to 21 months.)
- Change in parent anxiety and parental wellbeing(Baseline, 6 months, and up to 21 months.)
- Change in anxiogenic parenting behaviours(Baseline, 6 months, and up to 21 months)