A Multicenter, Randomized, Controlled Clinical Trial of Attention Reduction Intervention Therapy for Children With Transient Tic Disorder Primarily Characterized by Abnormal Blinking
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Score of the Yale Comprehensive Tics Severity Scale
研究概览
简要总结
Clarify the effectiveness and safety of "Reduced-Attention Intervention Therapy" in treating children with Provisional tic disorder （PTD） who mainly exhibit abnormal blinking behavior
详细描述
Children diagnosed clinically with PTD primarily characterized by abnormal blinking were recruited from multiple clinical centers and randomly assigned to two groups. The behavioral intervention group received "attention-reduction intervention therapy," while the control group continued with their previous clinical treatment regimen. After the initial observation period, participants in both groups crossed over to receive the same attention-reduction intervention therapy for an additional treatment cycle. The study evaluated changes in Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTSS) scores at the end of each intervention cycle compared to baseline. This study is designed as a prospective, multicenter, randomized, controlled clinical trial to validate these findings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Between 6 and 14 years old
- •the diagnosis is PTD characterized by abnormal blinking as the main manifestation
- •The legal guardian agrees and signs the informed consent form, and complies with the research protocol
排除标准
- •Received any other behavioral intervention treatment or took related therapeutic drugs within the past 3 months.
- •The current active allergic diseases
- •There are any eye disorders that may cause confusion in the interpretation of the research results
- •Having worn contact lenses within the past 3 months
- •The researchers determined that the participants were not suitable to participate in this study due to other reasons
研究组 & 干预措施
Behavioral intervention
The behavioral intervention group received the attention reduction intervention therapy.
干预措施: Reducing Attentional Interventions Therapy Treatment (Behavioral)
Control group
The control group did not receive the intervention therapy aimed at reducing attention, and subsequently was transferred to the attention reduction intervention therapy.
干预措施: Continue with the previous treatment plan (Other)
结局指标
主要结局
Score of the Yale Comprehensive Tics Severity Scale
时间窗: through study completion, an average of 6 months
Three evaluation researchers who had undergone unified training and were unaware of the group assignments independently conducted blinded scoring based on the standardized protocol and the medical records provided by the same guardian of the patients. The average value was then calculated.
次要结局
- YGTSS impairment subscale(through study completion, an average of 6 months)
- ocular and systemic Adverse Events (AEs)(through study completion, an average of 6 months)
- Self-Rating Depression Scale(SDS)(through study completion, an average of 6 months)
- Gilles de la Tourette Syndrome-Quality of Life scale(GTS-QOL)(through study completion, an average of 6 months)
研究者
Liang Dan
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University