跳至主要内容
临床试验/NCT02857023
NCT02857023已完成不适用

Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

Steven J. Hardy2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2014年10月1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
91
试验地点
2
主要终点
Cogmed feasibility assessed by program completion rates

研究概览

简要总结

Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
  • 7 to 16 years old.
  • An absolute or relative working memory deficit.
  • IQ of 70 or greater, as measured via the WISC-V.
  • Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.

排除标准

  • Visual, motor, or auditory impairment that prevents computer use.
  • Insufficient English fluency.
  • Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
  • Unreliable access to a source of electricity to charge an iPad battery.

研究组 & 干预措施

Cogmed intervention

Experimental

Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)

干预措施: Cogmed RM (Behavioral)

Cogmed-waitlist control

Experimental

Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)

干预措施: Cogmed RM (Behavioral)

结局指标

主要结局

Cogmed feasibility assessed by program completion rates

时间窗: Following completion of Cogmed (approximately 8-10 weeks from baseline)

Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).

次要结局

  • Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest(Baseline, 8-10 weeks, 6-month follow-up)
  • Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest(Baseline, 8-10 weeks, 6-month follow-up)
  • Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest(Baseline, 8-10 weeks, 6-month follow-up)

研究者

发起方
Steven J. Hardy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steven J. Hardy

Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences

Children's National Research Institute

研究点 (2)

Loading locations...

相似试验

Feasibility and Efficacy of a Home-based,... | 临床试验