A Pilot Randomised Controlled Trial of 'The Shadow of Tallystick Valley' for Children and Young People Experiencing Family Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Stirling Children's Wellbeing Scale (SCWBS)
研究概览
简要总结
The study is investigating the feasibility and acceptability of the story-based intervention, The Shadows of Tallystick Valley, aimed at improving the psychological wellbeing and resilience of children and young people who are affected by familial substance use. A secondary aim of the study is to identify whether there is a 'signal of efficacy'. The early intervention is a story and activity book designed and developed by Book of Beasties, in collaboration with the charity Change Grow Live (CGL), who work directly with children and young people experiencing familial substance use. The intervention is used by s at CGL with children and young people engaged with the service. In the present study, we aim to evaluate the story-based intervention within a pilot randomised controlled trial. Participants will be randomised to either receive the intervention or to join a waitlist for the same intervention. The effects of the story-based intervention will be assessed using pre and post psychological well-being and resilience measures, including KidCOPE, the Stirling Children's Wellbeing Scale and the Child and Youth Resilience Measure. The primary outcome measures are concerned with overall psychological wellbeing.
详细描述
The aims of this pilot trial are as follows:
To determine whether a full trial is justified; To determine the feasibility and acceptability of the story-based intervention in improving psychological wellbeing and emotional literacy in children and young people experiencing familial substance use; To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial.
To establish the feasibility of the intervention, we will collect data on the primary outcome for at least 80% of the recruitment target, and have an attrition rate that does not exceed 40%. A definitive trial will be justified if we are able to successfully recruit and retain participants in the trial, and if both the trial procedures and intervention are deemed to be acceptable to participants. Although the primary aim of pilot RCTs is to answer questions related to feasibility, an important secondary aim is to determine whether there is a signal of efficacy so as to inform the decision to progress to a definitive trial (Beets et al., 2021). The between-group effects will determine whether there is a signal of efficacy in favour of the Shadow of Tallystick Valley intervention and further support the need for a definitive randomised controlled trial (RCT). A signal of efficacy will be considered to be found if the between-group effect size on the co-primary outcomes is in favour of the intervention. Where these conditions are met, this study will therein provide the parameters needed to estimate the sample size for a definitive RCT. We will assess whether the study design is acceptable to participants using recruitment and retention rates (i.e., study and intervention uptake and dropout rates) and qualitative interviews with participants.
The intervention will be offered to children and young people already connected with CGL. Children and young people are referred to the service via a referral from an adult known to them. This can include (but is not limited to) family members, social workers, teachers, school staff, substances, or other youth worker professionals.
Recruitment methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The children and young people will not know which group they have been assigned to.
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 7 - 14 years;
- •Child: 7 - 10
- •YP: 11 - 14
- •Able to read age appropriate materials independently;
- •Have someone in their family using alcohol and/or substances;
- •Have received parental/caregiver consent to take part in the study;
- •Have an assigned support worker
排除标准
- •They are below age 7 years or above 14 years;
- •They are currently engaging in self-harm, including all forms of self harm as set out by Mind (2020), and/or have plans to end their life;all forms of self harm
- •Have not given consent to take part in the study;
- •Have not received parent or caregiver consent to take part in the study.
结局指标
主要结局
Stirling Children's Wellbeing Scale (SCWBS)
时间窗: Two weeks
The Stirling Children's Wellbeing Scale (SCWBS) (Liddle and Carter, 2015) is a 15-item questionnaire measuring wellbeing.
次要结局
- Child and Youth Resilience Measure(Two weeks)
- KidCOPE(Two weeks)
研究者
India Smith
Trainee Clinical Psychologist
University of Surrey