Mobile App Training for Impulsivity

(DelTA Trial)

Overseen By Samantha Blair, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Autism, Intellectual disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help preschool-aged children with high impulsivity improve their self-control using a mobile app. The app features games that encourage children to gradually increase the time they wait for bigger rewards, fostering better self-control without medication. This approach, known as Shaping Delay Tolerance (also referred to as Delay Tolerance Training or Self-Control Enhancement), is designed to enhance self-control in children. Participants will be divided into two groups: one will begin the app training immediately, while the other will wait six weeks before starting. Children aged 3-6 who experience high levels of impulsivity and can use a tablet may be eligible to participate. As an unphased trial, this study offers a unique opportunity for children to benefit from innovative self-control training without medication.

Will I have to stop taking my current medications?

Participants can continue taking their current medications, but they must keep the same medication and dose throughout the study.

What prior data suggests that this mobile app training is safe for children?

Research shows that the Shaping Delay Tolerance treatment is generally easy for children to handle. Studies have found that gradually increasing the time children wait for rewards helps them develop better self-control without causing major issues. In these studies, children practiced waiting for bigger rewards over time, and this method did not lead to any significant problems.

This approach has been used safely in homes and schools. Reports have not indicated any harmful side effects from this type of training. Since it doesn't involve medication, it is considered a safe option for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile App Training for Impulsivity because it takes a fresh approach to managing impulsivity through behavioral intervention. Unlike traditional methods that might rely heavily on medication or in-person therapy sessions, this technique focuses on Shaping Delay Tolerance, helping individuals improve their self-control through a digital platform. This app provides the flexibility and accessibility of treatment from anywhere, potentially making it more convenient and engaging for users. By offering tailored exercises aimed at enhancing patience and delay tolerance, this method could lead to more sustainable self-regulation skills without the side effects associated with medication.

What evidence suggests that this mobile app training is effective for increasing self-control in children with high impulsivity?

Research has shown that games designed to gradually increase the time children wait for rewards can improve self-control in highly impulsive children. One study found that before playing these games, children could wait between 1.7 to 51.7 seconds. After playing, they could wait between 37.5 to at least 90 seconds. This approach gradually increases waiting times to help children become more patient and better at delaying gratification. The current trial tests this concept with a mobile app called Shaping Delay Tolerance to determine if it can effectively teach self-control through technology. Participants in the Experimental arm will begin this training immediately, while those in the Wait-list Control arm will start after a 6-week waiting period. Early results suggest these games could be a promising non-drug method to teach self-control. ^{6 7 8 9 10}

Who Is on the Research Team?

Julie B Schweitzer, PhD

Principal Investigator

UC Davis MIND Institute

Are You a Good Fit for This Trial?

This trial is for preschool-aged children (3-6 years old) who show high levels of impulsivity, as indicated by specific rating scales. They must be physically and visually able to use a tablet and if on medication, keep the same type throughout the study.

Inclusion Criteria

My child is on stable psychotropic medication and shows high impulsivity despite the medication.

I am between 3 and 6 years old.

Physically and visually able to use the tablet, as determined by pre-assessment performance

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants in the Wait-list Control arm undergo effortful control assessments and behavior questionnaires

6 weeks

Treatment

Participants receive the Shaping Delay Tolerance behavioral intervention

6 weeks

Follow-up

Participants are monitored for changes in self-control and impulsivity through various tasks and questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shaping Delay Tolerance

Trial Overview

The study tests whether self-control in highly impulsive young children can be improved using mobile app games that reward them for waiting longer times for better rewards. It builds on earlier work showing success with non-digital games.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Wait-list Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A study of nearly 60 individuals who participated in a delay-of-gratification task as preschoolers found that those who struggled to delay gratification showed poorer impulse control and greater sensitivity to appealing cues, like happy faces, in their mid-forties.

Functional imaging revealed that high delayers had better activation of the prefrontal cortex for impulse control, while low delayers exhibited increased activity in the ventral striatum, indicating a neural basis for their difficulties in resisting temptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and neural correlates of delay of gratification 40 years later. Casey, BJ., Somerville, LH., Gotlib, IH., et al.[2022]

The 'marshmallow test' developed in the 1960s has shown strong predictive validity for important life outcomes, such as social skills and mental health, based on preschoolers' ability to delay gratification.

Research into the cognitive strategies behind delay of gratification suggests that understanding these mechanisms can help explain individual differences in self-regulation and willpower throughout life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Willpower' over the life span: decomposing self-regulation. Mischel, W., Ayduk, O., Berman, MG., et al.[2021]

Rats identified as highly impulsive showed significant deficits in 'waiting impulsivity,' as they struggled with delay-of-reward tasks, which may reflect similar behaviors in humans with ADHD and drug addiction.

The study suggests that impulsivity related to waiting for rewards could be a key factor in the development of compulsive behaviors, such as cocaine addiction, highlighting the potential for targeted interventions in neuropsychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural characterisation of high impulsivity on the 5-choice serial reaction time task: specific deficits in 'waiting' versus 'stopping'. Robinson, ES., Eagle, DM., Economidou, D., et al.[2022]

The study identified specific neural connections in the subthalamic nucleus that are linked to waiting impulsivity, showing that lower connectivity in this area is associated with impulsive behaviors, particularly in binge drinkers and individuals with alcohol use disorders.

Using advanced imaging techniques, the research demonstrated that the connectivity patterns in the subthalamic nucleus can differentiate between binge drinkers, those with alcohol use disorders, and healthy individuals, highlighting the potential for targeted interventions in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jumping the Gun: Mapping Neural Correlates of Waiting Impulsivity and Relevance Across Alcohol Misuse. Morris, LS., Kundu, P., Baek, K., et al.[2022]

The study compared two tasks, the Stop Signal Task (SST) and the Choice-Delay Task (C-DT), to assess their effectiveness in distinguishing children with ADHD from those without, finding that using both tasks together provided excellent discriminant validity.

Delay aversion, as measured by the C-DT, was strongly linked to various ADHD symptoms and behaviors, while the SST primarily related to inhibitory control, indicating that delay aversion may reflect a broader range of ADHD characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ecological validity of delay aversion and response inhibition as measures of impulsivity in AD/HD: a supplement to the NIMH multimodal treatment study of AD/HD. Solanto, MV., Abikoff, H., Sonuga-Barke, E., et al.[2019]

This review systematically compares state regulation deficits (SRD) and delay aversion (DAv) in ADHD, highlighting their core and secondary manifestations, which can help in understanding the unique and overlapping features of these dysfunctions.

The study emphasizes the importance of differentiating between DAv's preference for immediate rewards and SRD's slow event rate effect, suggesting that targeted experimental manipulations can clarify these neuropsychological patterns and improve ADHD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Context-dependent dynamic processes in attention deficit/hyperactivity disorder: differentiating common and unique effects of state regulation deficits and delay aversion. Sonuga-Barke, EJ., Wiersema, JR., van der Meere, JJ., et al.[2021]

The Continuous Delay Aversion Test (ConDAT) is a new computer-based task designed to measure delay aversion, a motivational style linked to ADHD, by presenting subjects with a diminishing reward/delay ratio.

Pilot data suggests that ConDAT is reliable and valid, making it a flexible tool for neurophysiological studies and brain imaging experiments, potentially improving our understanding of ADHD-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online measurement of motivational processes: introducing the Continuous Delay Aversion Test (ConDAT). Müller, UC., Sonuga-Barke, EJ., Brandeis, D., et al.[2019]

A study with 12 male Wistar rats showed that training with delayed reinforcement (delay-exposure training) significantly reduced impulsive choices compared to training with immediate reinforcement (immediate-exposure training).

The reduction in delay discounting was stable over time, as delay-exposed rats continued to show less impulsive behavior even 120 days after the initial training, suggesting that this training method could be effective for long-term behavior modification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impulsive choice and pre-exposure to delays: III. Four-month test-retest outcomes in male wistar rats. Renda, CR., Madden, GJ.[2019]

A systematic review of 98 studies involving participants aged 12 and older found that delay discounting (DD), the tendency to prefer smaller immediate rewards over larger delayed ones, can be significantly reduced through various behavioral trainings and manipulations.

The most effective strategies identified include acceptance-based/mindfulness-based trainings and interventions that promote a future-oriented mindset, suggesting that DD is not fixed and can be influenced by context and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral trainings and manipulations to reduce delay discounting: A systematic review. Scholten, H., Scheres, A., de Water, E., et al.[2023]

In a study using positron emission tomography with healthy volunteers, lower binding of D2/D3 autoreceptors in the midbrain was linked to higher levels of impulsivity, suggesting a biological basis for impulsive traits.

Increased dopamine release in the striatum, triggered by amphetamine, was associated with greater impulsivity and stimulant craving, indicating that dopamine signaling plays a crucial role in impulsive behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dopaminergic network differences in human impulsivity. Buckholtz, JW., Treadway, MT., Cowan, RL., et al.[2022]

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