Adding Printed CBT Materials to a Pediatric Digital Intervention
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: Mightier.
- Кому может быть актуально
- Состояния в реестре: Emotional Regulation. Базовые параметры: 4 лет — 16 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Examining the Impact of Adding Printed CBT Materials to a Pediatric Digital Emotional Regulation Intervention
Обзор
The primary goal of this study is to demonstrate that engaging with "offscreen" physical materials that focus on teaching and practicing Cognitive Behavioral Therapy-based skills alongside a digital emotional regulation intervention results in greater symptom improvement in kids than engaging with the digital intervention alone. Participants are children who are using Mightier a video-game based heart rate biofeedback intervention used to build emotion regulation. Caregivers will be asked to complete a short survey prior to their child's first play and then complete that survey at 12 weeks post baseline. The pre-post self-report design, combined with analyses accounting for engagement with offscreen materials will allow the investigators to observe changes during Mightier use and relate those changes to type of program engagement. (edited)
Подробное описание
Mightier is an app-based biofeedback videogame platform that utilizes heart rate (HR) monitoring during gameplay to teach and facilitate practice of emotional regulation skills in children ages 6-14. The effectiveness of Mightier has been supported through several studies in children ages 8-18, specifically reducing symptoms of aggression, oppositional behavior, and parental stress. The developers of Mightier have recently created "offscreen" physical materials that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts. While these materials are based on empirically supported principles, it remains unclear whether they impart additional clinical benefit when used in conjunction with the validated video game. Investigators seek (1) a better understanding of how offscreen materials may support digital experiences, and (2) to provide preliminary evidence that these specific offscreen experiences provide clinical benefit to families, rather than solely entertainment benefit.
For this proposed study investigators hypothesize the following:
1. Caregivers will report family engagement with CBT printed materials. 2. Caregivers who indicated high family engagement with printed CBT materials will report larger gains in emotional awareness and emotional regulation than those who did not engage, or engaged minimally, with CBT printed materials. 3. Caregivers will report significantly greater feelings of self-efficacy after using the Mightier program. 4. Those who reported high family engagement with printed CBT materials will report higher increases in parenting self-efficacy.
For the duration of the 12 week intervention period, participants will play Mightier and engage with CBT-based printed materials ad libitum. They will not receive any special instructions or recommendations outside of those provided to all Mightier families. Consistent with any other family using Mightier, participating families will be free to engage with or deny all programming associated with Mightier (e.g. email updates and other support). All individuals engaging with participating families to facilitate the standard Mightier experience will be blinded to their participation in research.
Participating families will be contacted via email to complete follow-up measures at 12 weeks. Participants will only be sent these emails if they are customers of Mightier at the time of follow up.
Вмешательства
- Поведенческое Mightier
Mightier is a pediatric at-home intervention program that includes an app-based biofeedback video game that utilizes heart rate (HR) monitoring during game play to teach and facilitate practice of emotional regulation skills in children ages 6-14. The program also uses physical materials including printed workbooks and conversation cards that focus on teaching additional Cognitive Behavioral Therapy (CBT)-based skills and concepts.
Первичные конечные точки
- Difficulties in Emotion Regulation Scale-Parent (DERS-P) [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (2)
- Brief Parental Self-Efficacy Scale (BPSES) [Срок оценки: Baseline and Week 12]
- Parent Reported Clinical Global Impression- Improvement (CGI-I) [Срок оценки: Week 12]
Критерии участия
Критерии включения
- Age 4-16 years old at time of enrollment
- Regular access to WiFi (for Mightier gameplay device connection)
- Independently elected to engage with Mightier program
Критерии исключения
- Previous use of Mightier
- Under the age of 4
- Older then 16 years of age
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06580496 · 2594