- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05689736
Оптимизация основанной на фактических данных распространяемой бесплатной интернет-программы для родителей
The CDC's Essentials for Parenting Toddlers and Preschoolers program (EFP) is a free Internet resource with the potential to break down barriers to population-wide access to scientifically-based parenting interventions. EFP has considerable promise, but parental engagement, a major issue in the success of universal parenting interventions, remains a challenge. The objective of the proposed research is to optimize EFP by identifying engagement-focused intervention elements to add to EFP that enhance its effects on parenting skills.
Обзор исследования
Статус
Условия
Подробное описание
The study is a longitudinal factorial optimization trial in a community sample of 800 parents with 1.5- to 3-year-old children. There are 4 experimental factors; each corresponds to the presence vs. absence of an engagement-focused intervention element. This experiment enables the estimation of the individual and combined effects of each element. The specific aims follow.
Aim 1: Optimize the effects of EFP on parenting skills by determining which combination of the four experimental engagement-focused intervention elements results in the greatest success of EFP, as reflected in increasing parent warmth and reducing corporal punishment, overreactive and lax discipline.
Aim 2: Determine the extent to which boosted meaningful parent engagement in EFP is the mechanism driving the effects of the four engagement-focused intervention elements on parenting skills, and which aspect(s) of engagement (e.g., content consumption; behavioral skills practice) are the key mediators that translate the effects of the four engagement-focused intervention elements into improved parenting.
Aim 3: Examine parent (e.g., change readiness; race) and child characteristics (e.g., externalizing behavior; sex) to determine if the optimal intervention package differs among subgroups. Cracking the code of providing parents with an intervention that they actually use, and that improves parenting, could have far-reaching effects (e.g., improving population-level child outcomes).
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Maryland
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Rockville, Maryland, Соединенные Штаты, 20850
- Westat, Inc.
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 18- to 36-month-old child
- ≥18-year-old parent
- Internet access
- willingness to commit to intervention/assessment procedures
- proficiency in speaking and reading English
Exclusion Criteria:
- child older than 36 months
- parent younger than 18 years
- no access to internet
- not willing to commit to intervention/assessment procedures OR
- not proficient with speaking and reading English
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Факторное присвоение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Motivational Enhancements + Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core Essentials for Parenting (EFP) intervention and all additional engagement-focused intervention elements: motivational enhancements, simplification, gamification, and low engagement nudges. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Simplification + Gamification
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and gamification intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and low engagement nudges as intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Simplification
Participants will receive the Core EFP intervention and motivational enhancement and simplification as intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, gamification, and low engagement nudge as intervention elements. |
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Gamification
Participants will receive the Core EFP intervention and motivational enhancement and gamification as intervention elements. |
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement and low engagement nudge as intervention elements. |
Motivational Enhancements (ME) will include three features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Motivational Enhancements
Participants will receive the Core EFP intervention and motivational enhancement as an additional intervention element. |
Motivational Enhancements (ME) will include three features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification, gamification, and low engagement nudge as additional intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Simplification + Gamification
Participants will receive the Core EFP intervention and simplification and gamification as additional intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification and low engagement nudge as intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Simplification
Participants will receive the Core EFP intervention and simplification as an additional intervention element. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and gamification and low engagement nudge as additional intervention elements. |
Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Gamification
Participants will view the Core EFP and will be exposed only to gamification as an additional intervention element. |
Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: Low Engagement Nudge
Participants will receive the Core EFP intervention and low engagement nudge as an additional intervention element. |
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Экспериментальный: EFP Only
Participants will receive the Core EFP intervention and not be exposed to any additional intervention elements. |
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Parent Behavior Inventory, item average of Supportive/Engaged subscale
Временное ограничение: 6 months
|
Parental warmth (e.g., physical affection) will be measured by parent completing the 10-item self-report Supportive Engaged subscale of the Parent Behavior Inventory. |
6 months
|
|
Parent-Child Conflict Tactics Scale, item average of Corporal Punishment subscale
Временное ограничение: 6 months
|
Corporal punishment (noninjurious physical discipline, e.g., spanking) will be measured by parent completing the 6-item self-report corporal punishment subscale of the Parent-Child Conflict Tactics Scale |
6 months
|
|
Parenting Scale, item average of Overreactivity subscale
Временное ограничение: 6 months
|
Parents' use of harsh or otherwise overreactive discipline (i.e., angry discipline) will be measured by parent completing the 10-item self-report Overreactivity subscale of the Parenting Scale. |
6 months
|
|
Parenting Scale, item average of Laxness subscale
Временное ограничение: 6 months
|
Use of permissive or lax discipline (e.g., failure to enforce rules) will be measured by parent completing the 11-item self-report Laxness subscale of the Parenting Scale |
6 months
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Kimberly Rhoades, Ph.D., New York University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 1R01HD101634 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
There is not a plan to make IPD available.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .