All Hands on Deck: Youth, Therapists, Parents and School Professionals Joining Forces in a Personalized, Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Individualized treatment goals
研究概览
简要总结
A substantial part of children/adolescents with anxiety or obsessive-compulsive disorder (AD/OCD) do not profit substantially from first-choice treatment (i.e., cognitive behavioral therapy; CBT). For them, no evidence-based treatment is available. The aim of this project is to evaluate and optimize a newly-developed personalized, short, and intensive exposure-based intervention, 'HANDS-ON', for 'treatment non-responders'. Collaboration with children, parents and teachers, guided exposure in a child's natural environment, personalized treatment goals and meaning/motivation are central principles.
Methods: A multiple baseline single-case experimental design is used (qualitative and quantitative). Participants are children/adolescents (10-18 years; N=12) with an AD/OCD diagnosis for whom standard CBT did not lead to sufficient improvement. Children and parents are asked to complete questionnaires before, during, and after the treatment. Children, parents, and school professionals will be asked to participate in qualitative interviews to evaluate their experiences with the HANDS-ON treatment program.
详细描述
BACKGROUND Nearly half of children and adolescents with anxiety or obsessive-compulsive disorders do not reach remission after first-choice treatment (cognitive behavioral therapy; CBT) and 10-25% discontinue treatment prematurely. For them, no evidence-based treatment is available. They may have severe symptoms with a huge impact on daily functioning, quality of life, family life, and society. These youth are at risk of developmental delays, among others due to school refusal. They often receive time-consuming, expensive treatment without evidence of effectiveness.
OBJECTIVES The aim of this project is to evaluate and optimize a newly-developed treatment for this group. This treatment, 'HANDS-ON', is innovative, short and intensive, based on scientific research and insights from clinical practice. Collaboration with children, parents and teachers, guided exposure in a child's natural environment, personalized treatment goals and meaning/motivation are central principles.
Our research questions are:
- Quantitative: What are (within-subjects) effects of HANDS-ON on personalized goal attainment, anxiety/OCD severity, and functioning in youth with persistent AD/OCD?
- Qualitative: What are the experiences, facilitators and barriers of HANDS-ON from a child, parent, school professional and therapist perspective?
The results of this study will be used to improve HANDS-ON, with the aim to further investigate its effectiveness in a randomised controlled trial as a next step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Note that research assistants will be blinded for the baseline length of participants during the interview assessments
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 10-18 years old;
- •Meeting DSM-5 criteria for an anxiety disorder/OCD, based on a semi-structured interview (SCID-5 Jr; [12]) and clinical judgement of an experienced and authorized clinician;
- •Non-responder to previous CBT (insufficient benefits from previous CBT for AD/OCD).
- •Comorbid diagnoses are allowed except for those interfering with safety or warranting immediate treatment, e.g., acute suicidality or psychosis.
排除标准
- •Severe psychiatric symptoms other than anxiety/OCD interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
研究组 & 干预措施
HANDS-ON treatment with random baselines
Participants are randomly allocated to one of four baseline periods (2.5 weeks, 3 weeks, 3.5 weeks, or 4 weeks). Participants then receive the HANDS-ON treatment. This treatment consists of three phases across nine weeks. After the treatment, there is a follow-up period of 4 weeks.
干预措施: HANDS-ON treatment (Behavioral)
结局指标
主要结局
Individualized treatment goals
时间窗: Daily child ratings (13 weeks), Timepoint0 (start baseline), Timepoint1 (pre-treatment), Timepoint2 (post-treatment, 9 weeks later), and Timepoint3 (follow-up, 4 weeks later); parent-rating at Timepoint0, Timepoint1, Timepoint2 and Timepoint3
Measured daily using the Goal Based Outcomes (GBO) questionnaire. Each participant will set 3 individualized anxiety/OCD-related goals for the treatment, scored on a scale from 1 - 10, where higher scores indicate improved goal progress.
次要结局
- Anxiety symptoms(Child and parent ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Family accommodation(Parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Motivation(Child ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Treatment adherence(Clinician rating at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline]))
- Severity/remission of primary diagnosis(Child and parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Treatment satisfaction questionnaire(Child and parent ratings at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline]))
- Daily anxiety or OCD symptoms(Child rating daily through baseline (2.5-4 weeks), treatment (9 weeks) and partially during follow-up (91 days [13 weeks] for each participant))
- OCD severity(Combined child and parent ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2))
- School refusal(Child and parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Clinical global impression(Clinician ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2))
- Qualitative interview(Between Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline]) and Timepoint3 (follow-up, 4 weeks after Timepoint2))