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Shaping Tolerance for Delayed Rewards (DelTA)

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ClinicalTrials.gov Identifier: NCT03457402
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Impulsivity Behavioral: Shaping Delay Tolerance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Basic Science
Official Title: Feasibility of Shaping Tolerance for Delayed Rewards in Impulsive 3-6 Year Olds
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

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.
Behavioral: Shaping Delay Tolerance
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.
Behavioral: Shaping Delay Tolerance
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Dinky Toy Task [ Time Frame: Up to 6 weeks ]
    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.

  6. 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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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457402


Contacts
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Contact: Samantha Blair, PhD 916-703-0325 hs-airlab@ucdavis.edu
Contact: Shannon Hoffman, DPT 916-703-0258 hs-airlab@ucdavis.edu

Locations
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United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Ryan Shickman, B.S.    916-703-0294    rdshickman@ucdavis.edu   
Contact: Shannon Hoffman, DPT    916-703-0294    slhoffman@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Julie Schweitzer, Ph.D. UC Davis MIND Institute
Publications:
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.
Liang K, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika 73:13-22; 1986.

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03457402    
Other Study ID Numbers: 921404
R03HD087091-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
delay discounting
shaping
Additional relevant MeSH terms:
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Impulsive Behavior