- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457402
Shaping Tolerance for Delayed Rewards (DelTA)
Feasibility of Shaping Tolerance for Delayed Rewards in Impulsive 3-6 Year Olds
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Blair, PhD
- Phone Number: 916-703-0325
- Email: hs-airlab@ucdavis.edu
Study Contact Backup
- Name: Shannon Hoffman, DPT
- Phone Number: 916-703-0258
- Email: hs-airlab@ucdavis.edu
Study Locations
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California
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Sacramento, California, United States, 95817
- Recruiting
- UC Davis MIND Institute
-
Contact:
- Ryan Shickman, B.S.
- Phone Number: 916-703-0294
- Email: rdshickman@ucdavis.edu
-
Contact:
- Shannon Hoffman, DPT
- Phone Number: 916-703-0294
- Email: slhoffman@ucdavis.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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.
|
Participants will be introduced to an adaptive tablet-based application that asks the child to choose between two options: 1) a shorter duration of game play that begins immediately, or 2) a longer duration of game play that begins after a delay.
Depending on the child's choices, the application alters the pre-reward delay with the intent of training the child to tolerate longer delays for larger rewards (i.e., more game play).
Children may participate in up to 25 approximately 30-minute training sessions over 3-6 weeks.
|
Active Comparator: Wait-list Control
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.
|
Participants will be introduced to an adaptive tablet-based application that asks the child to choose between two options: 1) a shorter duration of game play that begins immediately, or 2) a longer duration of game play that begins after a delay.
Depending on the child's choices, the application alters the pre-reward delay with the intent of training the child to tolerate longer delays for larger rewards (i.e., more game play).
Children may participate in up to 25 approximately 30-minute training sessions over 3-6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 weeks
|
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.
|
Up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHD-RS-IV Preschool Version and Attention and Behavior Rating Form
Time Frame: Up to 6 weeks
|
Parent and teacher ratings regarding the frequency of inattentive and hyperactivity/impulsivity ADHD symptoms.
Investigators predict that the shaping group will have better improvement in parent and teacher of ratings of impulsivity than the waitlist control group.
|
Up to 6 weeks
|
The Preschool Life Skills Questionnaire
Time Frame: Up to 6 weeks
|
A 13-item teacher scale that assesses behaviors noted as important to educators in predicting preschool success: instruction following, functional communication, delay tolerance, and friendship skills.
Investigators predict the greatest change in the delay tolerance scale in the shaping group compared to the waitlist control.
|
Up to 6 weeks
|
The Children's Behavior Questionnaire (CBQ)
Time Frame: Up to 6 weeks
|
A highly differentiated assessment of temperament in early to middle childhood.
Investigators predict the greatest change in the shaping group compared to the waitlist control.
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Up to 6 weeks
|
Snack Delay Task
Time Frame: Up to 6 weeks
|
An assessment of delay of gratification.
In this task, the child is invited to play a game in which he or she is asked to wait for varying intervals (5 seconds, 10 seconds, 20 seconds, 30 seconds) before they can a a parent-approved treat.
Behavior is coded for latency to touch and eat the snack (seconds).
Investigators predict that the shaping group will have better improvement in delay of gratification in the Snack Delay Task compared to the waitlist control group.
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Up to 6 weeks
|
Dinky Toy Task
Time Frame: Up to 6 weeks
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An assessment of effortful control.
In this task, the child is asked to look through a prize box containing toys while keeping his hands flat on the table.
The child should then select a prize verbally by indicating the name of the toy or providing a description of it.
Behavior is coded for latency to choose a prize and whether hands were removed from the designated table mat.
Investigators predict that the shaping group will have better improvement in effortful control as measured by the Dinky Toy Task compared to the waitlist control group.
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Up to 6 weeks
|
Gift Wrap and Gift Delay Task
Time Frame: Up to 6 weeks
|
An assessment of effortful control.
In this task, the experimenter shows the child a bag containing a present that still needs to be wrapped.
The child is told "try not to look" at the present during the wrapping process, which is completed by the experimenter at a table behind the child's back.
The rule is to not peek at the gift.
Sixty seconds later, when the experimenter has completed wrapping the gift, she will leave the room to search for a bow while instructing the child not to touch the present.
The experimenter returns in 3 minutes, places the bow, and awards the gift.
Behavior will be coded for the child's peeking strategy, and his latency to peek at the gift, touch the gift, and leave his seat while the experimenter is away.
Investigators predict that the shaping group will have better improvement in effortful control as measured by the Gift Wrap and Gift Delay Task compared to the waitlist control group.
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Up to 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Schweitzer, Ph.D., UC Davis MIND Institute
Publications and helpful links
General Publications
- Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
- Schweitzer JB, Sulzer-Azaroff B. Self-control in boys with attention deficit hyperactivity disorder: effects of added stimulation and time. J Child Psychol Psychiatry. 1995 May;36(4):671-86. doi: 10.1111/j.1469-7610.1995.tb02321.x.
- Putnam SP, Rothbart MK. Development of short and very short forms of the Children's Behavior Questionnaire. J Pers Assess. 2006 Aug;87(1):102-12. doi: 10.1207/s15327752jpa8701_09.
- Schweitzer JB, Sulzer-Azaroff B. Self-control: teaching tolerance for delay in impulsive children. J Exp Anal Behav. 1988 Sep;50(2):173-86. doi: 10.1901/jeab.1988.50-173.
- McGoey KE, DuPaul GJ, Haley E, et al. Parent and teacher ratings of attention-deficit/hyperactivity disorder in preschool: the ADHD Rating Scale-IV Preschool Version. J Psychopathol Behav Assess. 2007;29:269.
- Dunn LM, Dunn DM. Peabody Picture Vocabulary Test - Fourth Edition (PPVT-4). 2006. Toronto; Pearson: 2006.
- Hanley GP, Heal NA, Tiger JH, Ingvarsson ET. Evaluation of a class wide teaching program for developing preschool life skills. J Appl Behav Anal. 2007 Summer;40(2):277-300. doi: 10.1901/jaba.2007.57-06.
- Rothbart MK, Ahadi SA, Hershey KL, Fisher P. Investigations of temperament at three to seven years: the Children's Behavior Questionnaire. Child Dev. 2001 Sep-Oct;72(5):1394-408. doi: 10.1111/1467-8624.00355.
- Gagne JR, Van Hulle CA, Aksan N, Essex MJ, Goldsmith HH. Deriving childhood temperament measures from emotion-eliciting behavioral episodes: scale construction and initial validation. Psychol Assess. 2011 Jun;23(2):337-53. doi: 10.1037/a0021746.
- Liang K, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika 73:13-22; 1986.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 921404
- R03HD087091-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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