A Pilot Randomized Controlled Trial of Stepped vs Stratified Care for Pediatric Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Pediatric Anxiety Rating Scale (PARS)
研究概览
简要总结
The purpose of this trial is to evaluate the feasibility, acceptability, and safety of two care pathways (including internet-delivered cognitive behavioral therapy [CBT] and/or in-person CBT) for children and adolescents with anxiety disorders.
详细描述
Introduction: Anxiety disorders are a major contributor to disability in children and adolescents. Cognitive behavioral therapy (CBT), delivered both in-person and by the internet (ICBT), is efficacious, but how to best organize the care pathway to increase access and benefit is unclear.
Methods: With the aim to conduct a fully powered randomized controlled trial, the present study is a randomized controlled, single-blind, pilot study where 50 youth with anxiety disorders and their caregivers will be randomized (1:1) to stepped care or stratified care. Stepped and stratified care are two competing service delivery models which include evidence-based interventions but differ regarding the timing and staging of interventions.
In the stepped care arm, all participants will begin with 12 modules of ICBT delivered over 12 weeks. Participants with an insufficient response will then be offered 12-weeks of personalized in-person CBT. In the stratified care arm, the investigators aim to offer about half of the participants ICBT and the other half in-person CBT, with this selection being based on a risk score algorithm that integrates known predictors of non-response to treatment.
Mirroring the structure in stepped care, all non-responders in stratified care (both those who started with ICBT and in-person CBT) will be offered an additional 12-week course of in-person CBT. The ICBT and in-person CBT interventions will be identical in treatment length, but will differ in the delivery of treatment, utilizing the possibility of increased personalization and therapist-involvement in in-person CBT.
The objectives of the pilot study are to examine feasibility, acceptability, and safety of study procedures, precision of the risk score algorithm, and statistical properties of outcome measures. The feasibility, acceptability, and safety objectives are operationalized in detail in the full study protocol published at the Open Science Framework (OSF; see link in the References-section at the bottom of this record).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors conducting follow-up assessments (referred to as POST-1 and POST-2) will be blind to treatment allocation. At each follow-up assessment, participants will be reminded by their assessor to not reveal their study allocation. To measure blinding integrity, all assessors will record whether the participants inadvertently revealed their group allocation, and subsequently guess each participant's treatment allocation at each assessment point and motivate their choice. If the treatment allocation is accidentally revealed, the revelation part will be cut out of the Pediatric Anxiety Rating Scale audio recording and a new blind assessor will listen to the audio recording and conduct the rating that will be used in the trial. Subsequent assessments for that participant will then be conducted by someone different than the unblinded assessor. The primary analysis will be performed after the study's final participant has finished his/her POST-2 assessment.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8 to <18 years of age.
- •A principal Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia.
- •A Clinical Global Impression Scale - Severity (CGI-S) score >3 in relation to severity of all anxiety symptoms.
- •Child and caregiver able to read, write and communicate in Swedish.
- •An available caregiver who can support the child in treatment.
- •Access to the internet.
- •Ability to attend treatment sessions at the clinic.
排除标准
- •Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises).
- •Established or suspected intellectual disability.
- •Another mental disorder in more immediate need of management than an anxiety disorder (e.g., schizophrenia spectrum and other psychotic disorders, bipolar disorder, anorexia nervosa, substance use disorders).
- •Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
- •Ongoing psychological treatment for an anxiety disorder.
- •Initiation or adjustment of any psychotropic medication for anxiety (i.e., selective serotonin reuptake inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor or antipsychotics) within 8 weeks prior to assessment.
- •Immediate risk to self or others that require urgent attention, such as suicidality.
结局指标
主要结局
Pediatric Anxiety Rating Scale (PARS)
时间窗: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Used to assess anxiety severity. Clinician-rated. Primary clinical outcome of the study. The scale yields a score of 0 to 35, with higher scores indicating more severe anxiety.
次要结局
- Deliberate Self-harm Inventory - Youth version (DSHI-Y)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Children's Global Assessment Scale (CGAS)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Measure of accidental unmasking(POST-1 (week 14-17); POST-2 (week 30-33).)
- Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Clinical Global Impression Scale - Severity (CGI-S)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Clinical Global Impression Scale - Improvement (CGI-I)(POST-1 (week 14-17); POST-2 (week 30-33).)
- Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Child version (IDAS-II-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Need for treatment - Child version(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Revised Child Anxiety and Depression Scale - Child version (RCADS-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- The Treatment Inventory of Costs in Patients With Psychiatric Disorders (TIC-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Need for treatment - Parent version(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Number of participants with concomitant interventions(POST-1 (week 14-17); POST-2 (week 30-33).)
- Guess of group allocation(POST-1 (week 14-17); POST-2 (week 30-33).)
- Interviews with participants about treatment(POST-1 (week 14-17) or POST-2 (week 30-33).)
- Child Health Utility 9D (CHU9D)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Experiences of participating in the study(POST-2 (week 30-33).)
- Systematic Clinical Outcome and Routine Evaluation-15 - Child version (SCORE-15-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Client Satisfaction Questionnaire - Child version (CSQ-8-C)(POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).)
- Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- The PROMIS peer relationships short form (PR-SF)(Week 1; POST-2 (week 30-33).)
- Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)(Week 1; POST-2 (week 30-33).)
- Hierarchical Personality Inventory for Children (HiPIC-30)(Week 1.)
- Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)(Week 1; POST-2 (week 30-33).)
- Adverse events questionnaire - Child version (AEQ-C)(Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
- Working alliance - Child version(Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
- Systematic Clinical Outcome and Routine Evaluation-15 - Parent version (SCORE-15-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Parent version (IDAS-II-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
- Client Satisfaction Questionnaire - Parent version (CSQ-8-P)(POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).)
- Adverse events questionnaire - Parent version (AEQ-P)(Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
- The Cognitive-attentional Syndrome Questionnaire (CAS-1)(Week 1; POST-2 (week 30-33).)
- Autism Phenotype Scale (APS)(Week 1; POST-2 (week 30-33).)
- Working alliance - Parent version(Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
- Behavioral, Emotional, and Social Skills Inventory (BESSI)(Week 1; POST-2 (week 30-33).)