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Clinical Trials/NCT03457402
NCT03457402
Recruiting
Not Applicable

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

University of California, Davis1 site in 1 country50 target enrollmentSeptember 12, 2017
ConditionsImpulsivity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Impulsivity
Sponsor
University of California, Davis
Enrollment
50
Locations
1
Primary Endpoint
Percent change in preference for longer, larger (LL) rewards
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2017
End Date
May 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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