跳至主要内容
临床试验/NCT03457402
NCT03457402招募中不适用

Feasibility of Shaping Tolerance for Delayed Rewards in Impulsive 3-6 Year Olds

University of California, Davis2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Percent change in preference for longer, larger (LL) rewards

研究概览

简要总结

Deficits in self-control are of major public health relevance as they contribute to several negative outcomes for both individuals and society. For children, developing self-control is a critically important step toward success in academic settings and social relationships, yet there are few non-pharmacological approaches that have been successful in increasing self-control. We found in our earlier studies that self-control can be increased in preschool-aged children with high impulsivity by using games in which they practice gradually increasing wait-time for larger, more delayed rewards. We are performing this current study to test if this training to increase self-control can be increased using mobile app technology, with computerized game time being used as a reward.

详细描述

Problems with self-control are of major public health relevance as they are associated with substance abuse, suicide attempts, lower academic functioning, poor financial planning, and physical and mental health issues that impact both individuals and society. The ability to obtain immediate rewards in our daily lives is increasing due to technological advances from on-line games to Amazon deliveries within 1 hour after placing an order. There are fewer opportunities for children to learn how to wait. For children, developing self-control is a critically important step toward success in academic settings and social relationships, yet there are few non-pharmacological approaches that have been successful in increasing self-control.

Our objective in this current proof-of-concept study is to replicate and extend our earlier finding (Schweitzer & Sulzer-Azaroff, 1988) in which we demonstrated that self-control could be increased in preschool-aged children with high rates of impulsivity by using a "shaping" procedure whereby delays to larger, more delayed rewards were gradually increased. In this study we will aim to show that shaping self-control can be implemented using more sophisticated experimental design and mobile app technology.

A principal goal of this R03 pilot project is to refine the procedural methods to ensure that they are developmentally-appropriate using a well-controlled design and procedures. Our plan is to develop and implement a mobile application ("app"), "Delay Tolerance Application" (DelTA) that administers real-time rewards in a delay discounting procedure, in which the child will choose between an immediate, shorter game playing and a delayed, longer version of playing the same game.

This project will assess the feasibility of delivering the procedure via a mobile app and test if computerized games are effective rewards in a delay discounting context for young children (3-6 years) given that previous methods used immediately consumable rewards (e.g., candy). Positive findings from this proof-of-concept project will support future clinical trial projects to improve self-control and the use of the procedure for other interventions. The app may eventually serve as a targeted, precision intervention for children who exhibit elevated impulsivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Care Providers are told about the two possible groups during the Consent and will be aware of their child's assignment in terms of whether the child begins treatment immediately after baseline or has to wait 6 weeks prior to treatment.

Members of the research team who are designated as video coders for the Effortful Control tasks will be blind to the group assignment of the participants in the video recordings.

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 3-6 years
  • Hyperactivity/Impulsivity subscale scores of the ADHD Rating Scale-IV Preschool Version (children 3 to 4 years of age) or the Attention and Behavior Scale (children 5 to 6 years of age) ≥ 90th percentile from either the parent or teacher's responses
  • Physically and visually able to use the tablet, as determined by pre-assessment performance
  • Children taking psychotropic medication will be included, but must maintain the same medication and dose over the course of the study and for each assessment and exhibit elevated levels of impulsivity based on parent or teacher ratings while medicated.

排除标准

  • Children with autism spectrum disorder and/or intellectual disability (by parent or teacher report or the NIH Toolbox Picture Vocabulary Test).

研究组 & 干预措施

Treatment

Experimental

Participants in the Experimental arm will begin the Shaping Delay Tolerance behavioral intervention immediately after baseline, and this training will last for about 6 weeks.

干预措施: Shaping Delay Tolerance (Behavioral)

Wait-list Control

Active Comparator

After baseline, participants in the Wait-list Control arm will wait for about 6-weeks before entering the pre-treatment phase, which is a repeat of effortful control assessments and behavior questionnaires, and then they will begin training for with the Shaping Delay Tolerance behavioral intervention.

干预措施: Shaping Delay Tolerance (Behavioral)

结局指标

主要结局

Percent change in preference for longer, larger (LL) rewards

时间窗: Up to 6 weeks

The percentage of trials in which the child selects the longer, larger (LL) reward option during the tablet-task assessment will be recorded. Investigators hypothesize that the shaping group will have greater increases in the percentage of trials for which they choose the LL rewards compared to the waitlist control group.

Indifference point

时间窗: Up to 6 weeks

The indifference point on the tablet-task assessment is defined as the delay interval at which the child chooses 50% longer, larger rewards and 50% shorter, smaller rewards. Investigators hypothesize that the shaping group will have greater increases in their indifference points than the waitlist control group.

次要结局

  • ADHD-RS-IV Preschool Version and Attention and Behavior Rating Form(Up to 6 weeks)
  • The Preschool Life Skills Questionnaire(Up to 6 weeks)
  • Dinky Toy Task(Up to 6 weeks)
  • Gift Wrap and Gift Delay Task(Up to 6 weeks)
  • The Children's Behavior Questionnaire (CBQ)(Up to 6 weeks)
  • Snack Delay Task(Up to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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