Initial Evaluation of a Stepped Care Model for Treating Mild to Moderate Childhood Anxiety in Primary Care: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment pace
研究概览
简要总结
Objectives: In the past ten years in Sweden, a new form of primary care units called first line mental health (FLMH) has been implemented to improve mental health services for children and adolescents. Using a structured and collaborative approach including experts, clinicians, and patients, the investigators have developed a transdiagnostic psychological intervention for anxiety based on cognitive behavioural therapy (CBT) that aims to fit the FLMH care context. The current study aims to test the CBT intervention "Step-by-Step" in a randomized pilot study (N=36) to explore the feasibility of the study design.
Rationale for study: Childhood anxiety is common and associated with suffering and impairment in several life areas. CBT is an evidence-based treatment for anxiety disorders in children, but there is a need of increasing access to treatment. Offering CBT for childhood anxiety in primary care is a way to offer early and accessible treatment. However, there is a lack of CBT interventions developed for and evaluated in primary care.
Prior to a properly powered randomized controlled study, evaluating efficacy of the Step-by-Step, the investigators need to conduct a pilot study to, primarily, establish the feasibility of the study design and trial procedures and secondarily, provide preliminary data on acceptability and clinical efficacy.
详细描述
INTRODUCTION Anxiety is the most common reason for contact with the first line mental health (FLMH) in Sweden. Anxiety disorders are associated with negative effects in several life areas such as school functioning, peer relationships, and family life. Anxiety disorders in children also predict a number of adverse future events such as depression, alcohol and drug abuse, suicide-attempts, and financial problems in young adulthood. Increasing access to evidence-based interventions (EBIs) for child and adolescent anxiety is an urgent task. Today, only a few children and adolescents with life-interfering anxiety use mental health services.
CBT is a treatment that usually involves efforts to change behavioral and thinking patterns. Numerous studies have found evidence for the efficacy of CBT in the treatment of child anxiety, but typically, these treatment programs have been developed for use in a psychiatric setting. The FLMH assignment focuses on early interventions (prevention and treatment) delivered to children and adolescents (and their parents) with mild to moderate mental health problems. A challenge for the FLMH services has been to identify EBIs for anxiety that fit the needs of their patients and their organization, as the available EBIs almost exclusively have been evaluated within the psychiatric domain (i.e., specialist care) rather than with primary care in mind. To solve this problem, FLMH services sometimes offer a full-length EBI, although it does not fit well into the primary care setting (typically the 10 session CBT group program Cool Kids). Or, more commonly, they shorten the intervention despite that empirical support is lacking concerning whether this can be done with maintained treatment efficacy.
Just because an intervention is evidence-based, it does not always fit seamlessly into a certain care setting. The context where the intervention was developed and tested often differ in substantive ways from the context where it is applied. For instance, staff training, resources and patient characteristics might be different. These differences between health care contexts means that EBIs often need to be adapted to fit with the new context. In the FLMH guidelines, CBT is the recommended intervention for child and adolescent anxiety. However, these guidelines refer to studies of comprehensive interventions, typically including ten or more sessions, developed for children with manifest clinical disorders. Consequently, providing CBT within the FLMH means a dilemma concerned with the extent to which the intervention needs to adhere to the original version and the extent to which changes in response to resource restraints and possibilities in the local care context can be done with maintained treatment acceptability and efficacy.
Recently, the investigators have used a structured co-creative approach to develop a CBT intervention to the FLMH in preparation for the current project. The investigators have conducted workshops with experts on CBT for childhood anxiety and with clinicians and heads of three FLMH units. The investigators have also interviewed parents with experience of participating (together with their child) in CBT for childhood anxiety. Based on this information the investigators have developed a treatment called "Step by Step", a stepped care approach to treat anxiety within primary care. During the past months, the investigators have also preliminary tested the acceptability, appropriateness, and feasibility of the Step-by-Step at one FLMH-unit, including 4 participants. Individual qualitative interviews were conducted with therapists, participating children and caregivers after completing the intervention. Interview data was analyzed using thematic analysis.
OBJECTIVES The overarching aim with this research project is to increase the availability to evidence-based psychological treatments for children with anxiety treated within primary care.
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 caregiver and subsequently by the 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 caregiver.
结局指标
主要结局
Recruitment pace
时间窗: Post intervention (defined as 12 weeks after the start of the intervention)
Number of included patients per month will be registered for each first line mental health unit, to explore the feasibility of conducting a full scale randomized controlled trial.
Patient completion rate
时间窗: Post intervention (defined as 12 weeks after the start of the intervention)
Based on patients' attendance in treatment, the investigators will calculate how many patients that attend more than 70% of the sessions.
Treatment hours
时间窗: Post intervention (defined as 12 weeks after the start of the intervention)
Based on patients' attendance in treatment, therapist time for each patient will be calculated. (For group sessions, hours will be multiplied by number of therapists, and divided by number of patients)
Therapists' views of the intervention
时间窗: Post intervention (defined as 12 weeks after the start of the intervention)
A eight item questionnaire will be rated by therapists regarding different aspects of the acceptability, appropriateness, and the feasibility of the intervention content and format.
Time between first assessment and treatment initiation
时间窗: Post intervention (defined as 12 weeks after the start of the intervention)
The investigators will explore number of days between first assessment and treatment initiation to explore if patients do access treatment within a reasonable period of time?
次要结局
- Client Satisfaction Questionnaire, CSQ (parent-rated)(Post intervention (defined as 12 weeks after the start of the intervention))
- The Pediatric Anxiety Rating Scale, PARS (clinician rated)(Post intervention (defined as 12 weeks after the start of the intervention)])
- Working Alliance Inventory, WAI (parent rated)(Post intervention (defined as 12 weeks after the start of the intervention))
- Treatment credibility inventory (parent- and child-rated)(Two weeks after the start of the treatment)
- The Pediatric Anxiety Rating Scale - self-rated, PARS-SR (parent- and child-rated)(Post intervention (defined as 12 weeks after the start of the intervention))
- The Revised Children's Anxiety and Depression Scale-25, RCADS-25 (parent- and child-rated)(Post intervention (defined as 12 weeks after the start of the intervention))
