Mobile App Training for Impulsivity

(DelTA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Julie B Schweitzer, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Disqualifiers: Autism, Intellectual disability

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Shaping Delay Tolerance, Delay Tolerance Training, Self-Control Enhancement for impulsivity?

Research shows that impulsivity, a key issue in conditions like ADHD and addiction, can be linked to difficulties in delaying gratification and waiting for rewards. Studies suggest that improving self-control and delay tolerance may help manage impulsivity by enhancing the ability to wait for future rewards. ^{1 2 3 4 5}

Is the mobile app training for impulsivity safe for humans?

The research articles provided do not contain specific safety data for the mobile app training for impulsivity or its related treatments under different names. Therefore, no relevant safety information is available from these sources. ^{1 4 6 7 8}

How is the Shaping Delay Tolerance treatment different from other treatments for impulsivity?

Shaping Delay Tolerance is unique because it uses a mobile app to train individuals to improve their self-control by increasing their ability to wait for rewards, which is different from traditional treatments that may not focus on enhancing delay tolerance through digital platforms. ^{1 3 4 9 10}

Research Team

Julie B Schweitzer, PhD

Principal Investigator

UC Davis MIND Institute

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• Shaping Delay Tolerance (Behavioral Intervention)

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.

Participant Groups

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+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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]

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]

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 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]

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]

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]

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]

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 '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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Online measurement of motivational processes: introducing the Continuous Delay Aversion Test (ConDAT). [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioural characterisation of high impulsivity on the 5-choice serial reaction time task: specific deficits in 'waiting' versus 'stopping'. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral and neural correlates of delay of gratification 40 years later. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Jumping the Gun: Mapping Neural Correlates of Waiting Impulsivity and Relevance Across Alcohol Misuse. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dopaminergic network differences in human impulsivity. [2022]

6. United States 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. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

'Willpower' over the life span: decomposing self-regulation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Behavioral trainings and manipulations to reduce delay discounting: A systematic review. [2023]