跳至主要内容
临床试验/NCT04111991
NCT04111991已完成不适用

Effectiveness of a Psychological Intervention for Children With Post-concussion Syndrome

Sean Rose2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)

研究概览

简要总结

This prospective randomized intervention study aims to determine if the Concussion Symptom Treatment Program (C-STEP), a cognitive behavioral therapy, improves outcomes for children with post-concussion syndrome.

详细描述

This prospective randomized intervention study aims to determine if C-STEP improves outcomes for children with post-concussion syndrome. Forty children with post-concussion syndrome referred to the Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).

C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.

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
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children age 10-17 years or adults age 18 years (total age range 10-18) at the time of the enrollment visit
  • Diagnosed concussion occurring between 1 month and 12 months prior to the enrollment visit
  • Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
  • Intent to participate in the full CCC treatment program (including exercise visits once per week)

排除标准

  • Adults unable to consent, Prisoners, Females currently known to be pregnant, Non-English speaking patient
  • Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)
  • Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)
  • Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)

研究组 & 干预措施

Usual Care

Active Comparator

Usual care in the NCH Complex Concussion Clinic

干预措施: Usual Care (Behavioral)

Usual Care + C-STEP

Experimental

Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

干预措施: Usual Care (Behavioral)

Usual Care + C-STEP

Experimental

Usual care in the NCH Complex Concussion Clinic, plus 4 weekly sessions of C-STEP

干预措施: C-STEP (Cognitive Behavioral Therapy) (Behavioral)

结局指标

主要结局

Change Pediatric Quality of Life Inventory, Version 4.0 (PedsQL)

时间窗: Day 0 to Day 35

This is a 23-item self and parent-reported quality of life metric. Each item is rated on a scale of 0-4. Scores range from 0-100 for each subscale (Physical Functioning; Emotional Functioning; Social Functioning; School Functioning) and for the total score. Higher scores are indicative of better quality of life.

Change in Sport Concussion Assessment Tool- Fifth Edition (SCAT-5) Concussion Symptoms

时间窗: Day 0 to Day 35

This is a 22-item self and parent-reported list of common concussion symptoms filled out on a 0-6 Likert scale. Scores range from 0 to 122. Higher scores are indicative of worse concussion symptoms.

次要结局

  • Change in Brain Connectivity(Day 0 to Day 35)
  • Change in Auditory Attention and Working Memory(Day 0 to Day 35)
  • Change in Phonemic Verbal Fluency(Day 0 to Day 35)
  • Change in Performance Validity(Day 0 to Day 35)
  • Change in Processing Speed(Day 0 to Day 35)
  • Change in Cognitive Flexibility(Day 0 to Day 35)
  • Change in Verbal Memory(Day 0 to Day 35)

研究者

发起方
Sean Rose
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sean Rose

Assistant Professor of Pediatrics

Nationwide Children's Hospital

研究点 (2)

Loading locations...

相似试验

Concussion Symptom Treatment and Education Program... | 临床试验