Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care: A Multisite Randomised Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Pediatric Anxiety Rating Scale, PARS (clinician rated)
研究概览
简要总结
Objectives: Over the past decade in Sweden, a novel approach to primary healthcare units, known as first-line mental health (FLMH), has been introduced to enhance mental health services for children and adolescents. Through a structured and collaborative method involving experts, clinicians, and patients, a trans-diagnostic psychological intervention for anxiety was formulated based on cognitive behavioural therapy (CBT), designed to align with the FLMH care framework. This study seeks to assess the efficacy of the CBT intervention "Step-by-Step" in a randomised, single-blind, parallel-group, multisite non-inferiority trial. The objective is to investigate whether this treatment is not less effective than the evidence-based Cool Kids program.
Rationale for the Study: Childhood anxiety is prevalent and linked to suffering and impairment across various life domains. While cognitive behavioural therapy (CBT) is a proven treatment for anxiety disorders in children, there is a pressing need to enhance access to such interventions. Introducing CBT for childhood anxiety within primary care settings offers an avenue for early and readily available treatment. However, a gap exists in the availability of CBT interventions specifically designed for and assessed within primary care contexts.
详细描述
BACKGROUND: Anxiety is the primary reason for contacting the First Line Mental Health (FLMH) in Sweden. Urgently needed is the increased accessibility of evidence-based interventions (EBIs) for child and adolescent anxiety. Cognitive behavioural therapy (CBT) has proven efficacy in child anxiety treatment, though predominantly within psychiatric settings. The FLMH focuses on early interventions for mild to moderate mental health problems in children and adolescents, posing a challenge in identifying EBIs adapted to their needs. The FLMH services often struggle with fitting full-length EBIs into primary care or, more commonly, shorten interventions without empirical support for maintained efficacy. A structured co-creative approach was used to develop a CBT intervention, "Step-by-step," for FLMH. Preliminary testing indicated acceptability, appropriateness, and feasibility, with positive feedback leading to minor revisions in the treatment manual.
OBJECTIVE: The overarching aim of this research project is to increase the availability of evidence-based psychological treatments for children with anxiety treated within primary care.
PRIMARY RESEARCH QUESTION: Is Step-by-step an effective and resource efficient treatment in reducing anxiety severity compared to an evidence-based and well-established treatment (Cool Kids).
SECONDARY RESEARCH QUESTIONS: Is Step-by-step more suitable for certain subgroups of patients in terms of baseline characteristics? Is Step-by-step non-inferior to the Cool Kids regarding children's depressive symptoms, and quality of life? Is Step-by-step non-inferior to the Cool Kids in reducing family accommodation and increasing parental self-efficacy? Are changes in family accommodation and parental self-efficacy mediators of treatment effects? Are there differences in mental health care utilisation between treatments (three-year follow up of health care registers)? Do Step-by-step and Cool Kids differ in terms of treatment adherence, patient satisfaction, and therapists' fidelity? Do Step-by-step and Cool Kids fit the needs of patients?
PROJECT DESCRIPTION: Half of the participants will be randomised to receive Step-by-step, and half of participants will be randomised to receive Cool Kids. All participants will be followed up 12 weeks after treatment initiation (post assessment), and one year after the post assessment. The primary endpoint is set to the post assessment. Participants will be asked to consent for linkage with registers, including retrieving information about utilization of health care up to three years after the post assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors conducting 12 weeks-assessments will be blind to treatment allocation. The outcome measure (PARS) is identical for both groups, ensuring that the assessors remain blind. At the 12 week-assessment, participants will be reminded to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is 7-12 years old (Confirmed by the parent/guardian and from medical records)
- •The child suffers from mild to moderate anxiety. The term "mild to moderate anxiety" has not been explicitly defined but is a term aimed to specify a demarcation between the FLMH and the psychiatric specialist services. Adequate level of care for the patient is decided based on an overall clinical assessment. The Children Global Assessment Scale (CGAS) is often used to guide the decision on level of care, where a CGAS value above 60 clearly indicates primary care services, a value below 50 clearly indicates specialist services. For values between 50 and 60 the overall clinical evaluation of symptom severity and impaired function guide the decision on level of care. (Confirmed by the assessor at the FLMH-unit).
排除标准
- •Other psychiatric or developmental disorders than anxiety, or social issues that primarily require other interventions, i.e., where an intervention targeting mild to moderate anxiety is not adequate. (Confirmed by assessor at the FLMH-unit).
- •The child has another ongoing psychological intervention. An ongoing psychological treatment for any other psychiatric disorder. (Confirmed by the parent/guardian).
结局指标
主要结局
Change in Pediatric Anxiety Rating Scale, PARS (clinician rated)
时间窗: Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment
The PARS is a semi-structured clinical interview aimed to assess the severity and functional impairment of anxiety in children aged 6-17 years. Questions are asked to both children and parents. The ratings of severity and impairment is made based on the overall picture of anxiety symptoms. PARS has been used as an outcome measure in several treatment studies.
次要结局
- Change in Brief Parental Self-Efficacy, BPSES (parent-rated)(Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment)
- Change in the Child Health Utility 9D, CHU9D (parent-rated)(Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment)
- Change in The Revised Children's Anxiety and Depression Scale, RCADS (child- and parent-rated)(Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment)
- Change in The Family Accommodation Scale - Anxiety, FASA-A (child- and parent-rated)(Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment)
- Change in Child Anxiety Severity Scale, CASS) (child- and parent-rated)(Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment)
研究者
Johan Åhlén
Principal Investigator
Karolinska Institutet