The Development of Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People: Protocol for a Single-case Experimental Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in scores on the Three Item Loneliness Scale (Klein et al., 2021) across the baseline, intervention and post-intervention phases.
研究概览
简要总结
Loneliness is a significant problem for young people and is associated with a range of physical and mental health difficulties. Meta-analyses have identified that interventions aimed at young people who report loneliness as their primary problem are lacking within the literature. In adults, the most effective interventions for loneliness are those which target the underlying maladaptive social cognitions. Therefore, the investigators have developed a modular Cognitive Behavioural Therapy (CBT) intervention for children and young people aiming to reduce their feelings of loneliness. The aim of this study is to conduct a multiple baseline single-case experimental design (SCED) to assess the efficacy, feasibility and acceptability of this intervention. In total 6-8 11-18-year-olds and their families will be recruited. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. Participants will complete a baseline assessment, before being randomised to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). Participants will then complete an average of 12 sessions of CBT, with the aim being to reduce their feelings of loneliness over 12 weeks. Participants will then complete a 12-day post-intervention phase. Participant loneliness will be repeatedly assessed throughout the three phases of the intervention using the Three-item Loneliness Scale, which will be the primary outcome. Secondary outcomes will be reliable and clinically meaningful change on the UCLA-LS-3, RCADS and SDQ. Feasibility and participant satisfaction will also be assessed and reported.
详细描述
The efficacy of CBT for loneliness in children and young people will be evaluated through a randomised multiple-baseline single case experimental design. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. In the SCED approach participants are repeatedly assessed on at least one independent variable, in this case self-reported loneliness on the Three-item Loneliness Scale, across each phase of the intervention. This repeated measurement and within subject replication is then used to test the effects of the intervention for individual participants.
The construction of this SCED trial and the reporting of the results will be in accordance with the Single-Case Reporting Guidelines in Behavioural Intervention (SCRIBE).
Participants will be recruited via advertisements emailed to schools, shared via social media and word of mouth. After consenting, participants and their parents/carers will complete a baseline eligibility assessment. Participants will complete a range of online questionnaires via a secure online platform. Participants will then attend a remote research assessment appointment to determine whether the family meet the eligibility criteria. The researcher completing the baseline and post-intervention assessments will not be involved in the clinical intervention and will be blinded to baseline allocation. After all baseline assessments for the participant group are completed, participants will be discussed within supervision to confirm that the participants meet eligibility criteria. Eligible participants will then be randomised using a random number generator to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). The decision to have a minimum of 12 observations per phase meets the requirements for guidelines and standards and will allow for sufficient power for Tau-U analysis.
Each of the participating families will then be contacted to inform them of their allocation. Randomisation and contacting of the families will be completed by a third researcher, who is not involved in either the clinical intervention or research assessments. A letter will also be sent to the participants General Practitioner (GP) informing them of the family's participation in the research study. The setting for the entire study will be remote, with both assessments and intervention sessions being conducted remotely a secure video platform.
All participants in the group will begin their baseline phase concurrently. During the baseline phase participants will be asked to complete the Three-Item Loneliness Scale each day via a secure online platform. SMS message reminders will also be sent to the participants and their parent/carers each day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The researcher who completes the assessments will be blinded to baseline allocation length
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 11-18
- •Score more than 42 on the UCLA-LS-3 (Russel, 1996), which is more than one standard deviation above the mean in a large community adolescent sample (Shevlin, 2015).
- •Have a parent/carer who is willing to take part in the study.
- •Report loneliness as their primary difficulty (i.e., they are able to identify relevant goal-based outcomes and their current difficulties are not attributable to a significant mental health problem).
排除标准
- •Currently receiving psychological therapy.
- •Started taking antidepressant in the last 8 weeks.
- •Eligibility assessment indicates a severe mental health problem not considered suitable for the trial intervention due to the clinical need for immediate intervention, e.g., active suicidality and psychosis.
- •Refusal for therapy sessions to be video recorded.
- •Having an intellectual disability at a level whereby they cannot access the intervention
- •Do not have access to a laptop or smartphone which they can use for video calls.
结局指标
主要结局
Change in scores on the Three Item Loneliness Scale (Klein et al., 2021) across the baseline, intervention and post-intervention phases.
时间窗: This study is a single-case experimental design. Participants will complete the measure daily during the baseline phase, each session during the intervention phase, and daily during the post-intervention.
Self-reported child loneliness. The scale is a brief three-item measure with possible scores ranging from 0-12, with higher scores indicating higher levels of loneliness.
次要结局
- UCLA-Loneliness Scale-3 (Russell, 1996)(Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.)
- The Strengths and Difficulties Questionnaires (SDQ) (Goodman, 2001)(Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.)
- The Revised Child Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000)(Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.)
研究者
Thomas Cawthorne
Trainee Clinical Psychologist
Royal Holloway University