Clinical trial NCT03457402: Shaping Tolerance for Delayed Rewards
Official title: Feasibility of Shaping Tolerance for Delayed Rewards in Impulsive 3-6 Year Olds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impulsivity
Keywords: delay discounting
shaping
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two possible groups.

Group 1: Treatment; this group begins 6-week training with the self-control shaping application immediately after baseline.

Group 2: Wait-list Control; After baseline, this group waits for 6-weeks before completing another pre-training assessment and then starts the 6-week training with the self-control application.
Primary purpose: BASIC_SCIENCE

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.

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).

Primary outcomes:
measure: Indifference point
timeFrame: Up to 6 weeks
measure: Percent change in preference for longer, larger (LL) rewards
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: ADHD-RS-IV Preschool Version and Attention and Behavior Rating Form
timeFrame: Up to 6 weeks
measure: The Preschool Life Skills Questionnaire
timeFrame: Up to 6 weeks
measure: The Children's Behavior Questionnaire (CBQ)
timeFrame: Up to 6 weeks
measure: Snack Delay Task
timeFrame: Up to 6 weeks
measure: Dinky Toy Task
timeFrame: Up to 6 weeks
measure: Gift Wrap and Gift Delay Task
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Julie Schweitzer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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