Randomised Pilot Control Trial for Reducing Anxiety Problems Among Children Indicated to Have Developmental Language Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
研究概览
简要总结
This study aims to pilot a world-first intervention, a mental health intervention augmented for children indicated with developmental language disorder (DLD). It serves as a proof-of-concept of how existing observational studies on these topics at the Centre for Research in Child Development (c.f. Tran-Sen; Gibber) can be translated into interventions. Mental health problems here are defined as anxiety type problems of social anxiety, specific phobia, separation anxiety and generalised anxiety. DLD is defined as a marked difficulty in oral language in the absence of biomedical causes (Bishop et al., 2017). This randomised pilot answers three uncertainties in preparation for a future definitive randomised control trial (RCT).
详细描述
This pilot aims to answer three uncertainties for a future randomised control trial (RCT), namely (1) Is the proposed intervention's efficacy sufficient (2) Are the proposed methods of recruitment sufficient (3) Are the proposed measures of evaluation sufficient Hypotheses: (1) Piloted intervention is sufficient for definitive RCT as 90% confidence intervals contain expected improvement versus treatment-as-usual (2) Piloted recruitment methods are sufficient for definitive RCT as recruitment rate is >4/month, dropout rate<25%. (3) Piloted measures are sufficient for definitive RCT as rates of unusable data are <20% and reliability alpha >.70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical interview (ADIS) will be administered by assessors who will not be told which arm participants are. Participants will be told not to mention intervention arm status to assessors.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shows signs of elevated anxiety, fear or stress, as rated on anxiety measures conducted by this study
- •Enrolled in Primary 1 to 6 in a Ministry of Education Primary School
- •Signs of a language difficulty [Either one of the following]
- •Existing clinical opinion/report of this when child >5 years old
- •Score <10th percentile on language measures conducted by this study
排除标准
- •Conditions which exclude Developmental Language Disorder (e.g. Autism, Intellectual Disability, Hearing Impairment, other biomedical conditions).
- •Non-anxiety disorder as primary mental health disorder
- •Currently receiving treatment for anxiety disorder (e.g. pharmacotherapy or psychotherapy).
结局指标
主要结局
Anxiety Disorders Interview Schedule (ADIS-IV; Brown et al., 2004)
时间窗: Administered at post treatment which is a maximum of 4 weeks from final session
The ADIS-IV is a semi-structured interview organised diagnostically to permit differential diagnoses of anxiety disorders. Its yields a severity rating (0 to 8) which is utilised here as the primary outcome
次要结局
- Screen for child anxiety related emotional disorders (SCARED; Birmaher et al., 1999)(Administered at post treatment which is a maximum of 4 weeks from final session)
- Child Anxiety Life Interference Scale (CALIS; Lyneham, et. al., 2013)(Administered at post treatment which is a maximum of 4 weeks from final session)
研究者
Shaun Goh Kok Yew
Lecturer
Nanyang Technological University