DRKS00030086已完成未知
Randomised controlled pilot study on the clinical benefit of the smartphone app medigital® ADHD/OPP (powered by eyelevel)
Medigital GmbH0 个研究点目标入组 139 人开始时间: 2022年9月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 139
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 11 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria for all cohorts:
- •-Child's age: 4;0-11;11 yrs.
- •-Child shows elevated parent-reported symptom scores on the DISYPS FBB-ADHS (ADHD total) and/or the DISYPS FBB-SSV (oppositional defiant behaviour subscale) at screening, scale scores >1.0.
- •-The child's symptomatology must occur in the family (clinical judgement)
- •-Sufficient reading skills and German language skills of the parent using the app and participating in the data collection (clinical judgement)
- •-Willingness and resources of the parent to actively participate in this study (clinical judgement)
- •- Written informed consent from the parent/legal guardian and oral/written assent from the child to participate in the study.
- •-Internet connection in the family’s home, smartphone and PC/notebook or tablet PC.
- •Inclusion criteria cohort 1 without intensive therapy:
- •-Child has a confirmed diagnosis of ADHD and/or ODD (ICD-10 diagnosis F90.0, F90.1, F90.8, F90.9, F98.80 and/or F91.3; clinical judgment).
- •Inclusion criteria cohort 2 suspected diagnosis:
- •-Child has a suspected diagnosis of ADHD and/or ODD (ICD-10 diagnosis F90.0, F90.1, F90.8, F90.9, F98.80 and/or F91.3; clinical judgment).
- •Inclusion criteria cohort 3 Pharmacotherapy with residual symptoms:
- •-Child has a confirmed diagnosis of ADHD prior to initiation of pharmacotherapy (ICD diagnosis F90.0, F90.1, F90.8, F98.80; clinical judgement).
- •-Stable pharmacotherapy (at least 4 weeks and longer) of the child with an ADHD medication.
排除标准
- •Exclusion criteria all cohorts:
- •-Child has another severe mental disorder (e.g., intellectual disability, autism, psychosis) (clinical judgement).
- •-Known severe mental disorder of the parent using the app and participating in data collection (e.g., severe addictive disorder, severe emotionally unstable personality disorder, psychosis) (clinical judgment)
- •-Inpatient treatment planned due to mental disorder of the child
- •-Simultaneous or planned use of an ADHD/ODD app within the next 4 months
- •-Simultaneous participation in other studies or other clinical research projects
- •-Participation in this study with another child at the same time
- •Exclusion criteria cohort 1 without intensive therapy:
- •-ADHD medication or medication for aggressive behaviour (e.g. neuroleptics) of the child, currently ongoing or planned for the next four months (clinical judgement)
- •-Intensive behavioural therapy of the child due to ADHD/ODD with usually at least 2 contacts per month or regular parent training due to the child's symptoms with usually at least 2 contacts per month in the course of the last 12 months, currently ongoing or planned in the next four months (clinical judgement)
- •Exclusion criteria cohort 2 suspected diagnosis:
- •Exclusion criteria cohort 3 pharmacotherapy with residual symptoms:
- •-Intensive behavioural therapy of the child due to ADHD/ODD with usually at least 2 contacts per month or regular parent training due to the child's symptoms with usually at least 2 contacts per month, currently ongoing or planned for the next four months (clinical judgement).
研究者
相似试验
已完成
4 期
Randomized controlled pilot study of the clinical efficacy of the Mika AppC51-C58Malignant neoplasms of female genital organsDRKS00023791Fosanis GmbH70
招募中
不适用
Randomized controlled clinical pilot study for the implementation of medical group visits in Germany following the CHCC-Model (Cooperative Health Care Clinics) for the treatment of patients with diabetes type II or hyper tonus in family practiceI10E11Essential (primary) hypertensionType 2 diabetes mellitusDRKS00004346384
已完成
不适用
Randomized controlled pilot trial for the clinical utility of exercise therapy in patients with CKDChronic kidney disease stage 3 - 5JPRN-UMIN000005091St. Marianna University School of medicine Department of Medicine Division of Nephrology & Hypertension20
招募中
4 期
Randomized clinical pilot study investigating the effect of Lactobacillus reuteri on subgingival biofilm formation on healing abutments and inflammatory status of surrounding peri-implant tissuesTooth replacementDRKS00030602Clinic of Conservative and Preventive Dentistry University of Zurich, Center of Dental Medicine28
已完成
不适用
Pilot Clinical Trial on HB01PACTR201704001120121Prof. J. I. Ikechebelu24