NCT03457402

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

8.6 years

First QC Date

March 1, 2018

Last Update Submit

July 10, 2025

Conditions

Keywords

delay discountingshaping

Outcome Measures

Primary Outcomes (2)

  • Indifference point

    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

    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 Outcomes (6)

  • ADHD-RS-IV Preschool Version and Attention and Behavior Rating Form

    Up to 6 weeks

  • The Preschool Life Skills Questionnaire

    Up to 6 weeks

  • The Children's Behavior Questionnaire (CBQ)

    Up to 6 weeks

  • Snack Delay Task

    Up to 6 weeks

  • Dinky Toy Task

    Up to 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Shaping Delay Tolerance

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.

Behavioral: Shaping Delay Tolerance

Interventions

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.

TreatmentWait-list Control

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 3193054BACKGROUND
  • 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.

    PMID: 7650090BACKGROUND
  • 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.

    BACKGROUND
  • Dunn LM, Dunn DM. Peabody Picture Vocabulary Test - Fourth Edition (PPVT-4). 2006. Toronto; Pearson: 2006.

    BACKGROUND
  • 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.

    PMID: 17624068BACKGROUND
  • 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.

    PMID: 11699677BACKGROUND
  • 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.

    PMID: 16856791BACKGROUND
  • 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.

    PMID: 21480723BACKGROUND
  • Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.

    PMID: 7168798BACKGROUND
  • Liang K, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika 73:13-22; 1986.

    BACKGROUND

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julie Schweitzer, Ph.D.

    UC Davis MIND Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Blair, PhD

CONTACT

Shannon Hoffman, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 7, 2018

Study Start

September 12, 2017

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations