Therapist-guided, Parent-assisted Remote Digital Behavioural Intervention for Tics in Children and Adolescents With Tourette Syndrome: an Internal Pilot Study and Single-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score
研究概览
简要总结
Online Remote Behavioural Intervention for Tics (ORBIT).
Primary objective: to evaluate the clinical effectiveness of BiP Tic, a therapist-guided, parent-assisted, internet-based behavioural therapy intervention for tics in young people, compared with usual care plus online education.
Secondary objectives include 1) optimising the design of the intervention, 2) undertaking an internal pilot, 3) evaluating cost effectiveness and 4) longer term impact, and 5) identifying barriers to implementation.
详细描述
The ORBIT (Online Remote Behavioural Intervention for Tics) trial is comparing the effectiveness of two treatments delivered online for children and young people with Tourette Syndrome or Chronic Tic Disorder. Families in England with a child/young person (aged 9-17 years) who experiences tics are being asked to take part. Interested families undergo a telephone screen with a researcher and then asked to complete an online questionnaire. They then attend a screening appointment at either Great Ormond Street Hospital (London) or Queen's Medical Centre (Nottingham).
Families that are eligible and want to take part are randomly allocated to one of two treatments. One treatment uses behavioural therapy (BT), the other involves psychoeducation. Both treatments last for 10-weeks and involve completing online chapters (for the parent and child) with the support of a therapist, there are also some tasks to complete offline. After finishing the treatment, families are asked to complete more questionnaires (at 3, 6, 12 and 18 months after starting the treatment). A smaller sample of families and healthcare professionals are also interviewed about their experience of participation. The study is looking to see if the online delivered treatment may be effective at helping children and young people manage their tics. The study is also exploring whether the online programme is acceptable to families, identifying any problems in getting families to take part/complete the programme and also healthcare professionals' views about the programme. It is important to research online therapy for tics because, at the moment, many people with tics do not get any therapy because there are not enough trained tic therapists. If online delivered treatment is effective, this may mean more children and young people could access tic therapy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 9 to 17: patient confirmed through screening.
- •Suspected or confirmed Tourette syndrome/ chronic tic disorder:
- •Including Moderate/severe tics: Score >15 on the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS); TTSS score>10 if motor or vocal tics only: researcher confirms at screening appointment
- •Competent to provide written, informed consent (parental consent for child aged <16): researcher confirms at screening appointment.
- •Broadband internet access and regular PC/ laptop/Mac user, with mobile phone SMS: patient confirmed through screening.
排除标准
- •Previous structured behavioural intervention for tics e.g. HRT/CBIT or exposure and response prevention within last 12 months: Patient confirmed through screening.
- •Change to medication for tics (start or stop tic medication) within the previous 2 months: Patient confirmed through screening and subsequent medication/interventions commenced throughout out the trial are recorded at each time point for analysis.
- •Diagnoses of alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa: Confirmed through parent DAWBA. DAWBAs that score people as being likely to have these conditions will be second reviewed by the CI (who is a medical expert) to ascertain that they should definitely be excluded from the trial. If the child is considered at immediate risk of suicide, the research team will inform the GP or usual treating clinician.
- •Moderate/severe intellectual disability: Confirmed through qualitative judgement of the assessor at the telephone screen (and confirmed at baseline through CAIDS-Q) through questions relating to type of school the child attends and previous diagnoses.
- •Immediate risk to self or others: Confirmed through screening questions and DAWBA. The participants GP will be informed of this.
- •Parent or child not able to speak or read/write English: Patient confirmed through screening by the assessor.
结局指标
主要结局
Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score
时间窗: Baseline, 3, 6, 12 and 18 months
Investigator administered semi structured symptom checklist of 46 tic disorder symptoms. The Total Tic Score is derived by adding the Total Motor Tic Score and the Total Phonic Tic Score
次要结局
- Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)(Baseline, 3, 6, 12 & 18 months)
- Assessing change in global functioning in participants using the Children's Global Assessment Scale(Baseline, 3, 6, 12 & 18 months)
- Assessing change in mood in participants using the Mood and Feelings Questionnaire(Baseline, 1, 3, 6, 12 & 18 months)
- Assessing change in quality of life in participants using the Child Health Utility 9D(Baseline, 3, 6,12,18 months)
- Assessing participants change in use of services using the Modified Client Service Receipt Inventory(Baseline, 3, 6, 12 & 18 months)
- Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire(Baseline, 3, 6, 12 & 18 months)
- Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q)(Screening/Baseline)
- Assessing change in anxiety in participants using the Spence Child Anxiety Scale(Baseline, 3, 6, 12 & 18 months)
- Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire(3 weeks)
- Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline(Screening/Baseline)
- Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.(3, 6, 12 & 18 months)
- Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire(Baseline, 3, 6, 12 & 18 months)
- Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome(Baseline, 3, 6, 12 & 18 months)
- Assessing change in side effects in participants using the Adverse events/side effects(Baseline, 1, 3, 6, 12 & 18 months)
- Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire(3 months)
- Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline(Screening/Baseline)
- Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline(Screening/Baseline)
- Assessing change in tics in participants using the Parent Tic Questionnaire(Baseline, 5wks, 3mths, 6mths, 12mths & 18 months)
- Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline(Screening/Baseline)
- Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire(3 months)
- Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline(Screening/Baseline)