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Идёт набор NCT03457402

Shaping Tolerance for Delayed Rewards

Без фазы С лечением Impulsivity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Shaping Delay Tolerance.
Кому может быть актуально
Состояния в реестре: Impulsivity. Базовые параметры: 3 лет — 6 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility of Shaping Tolerance for Delayed Rewards in Impulsive 3-6 Year Olds

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 trainin

Первичные конечные точки

  • Indifference point [Срок оценки: Up to 6 weeks]
  • Percent change in preference for longer, larger (LL) rewards [Срок оценки: Up to 6 weeks]
Вторичные конечные точки (6)
  • ADHD-RS-IV Preschool Version and Attention and Behavior Rating Form [Срок оценки: Up to 6 weeks]
  • The Preschool Life Skills Questionnaire [Срок оценки: Up to 6 weeks]
  • The Children's Behavior Questionnaire (CBQ) [Срок оценки: Up to 6 weeks]
  • Snack Delay Task [Срок оценки: Up to 6 weeks]
  • Dinky Toy Task [Срок оценки: Up to 6 weeks]
  • Gift Wrap and Gift Delay Task [Срок оценки: Up to 6 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • UC Davis MIND Institute — Sacramento

Публикации

  • 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 3193054
  • 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 7650090
  • 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. PMID 17624068
  • 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 11699677
  • 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 16856791
  • 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 21480723

Идентификаторы

NCT: NCT03457402 · 921404 · R03HD087091-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗