- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07676240
An Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting
Randomized Controlled Trial of an Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting
Father-child pairs (N=200; children ages 12-36 months) will be randomized to FIND-F or a waitlist control group. Assessments comparing the two groups will occur at baseline, end of program, and 6 months post-program. Our aims include:
Aim 1: Evaluate the main impacts of FIND-F on the primary program target (fathers' supportive parenting) and related child and parent outcomes.
Aim 2. Identify mechanisms of FIND-F's intervention effects.
Aim 3. Examine variation by select child, father, and program measures.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The proposed work will achieve three specific aims in the context of a two-arm, fully powered RCT. This will be one of the first large-scale RCTs focused on evaluating the impacts and underlying theory of a nurturing fathering program.
As fathers enroll, they will be randomly assigned to either FIND-F (Group A) or a waitlist control group (Group B). A waitlist control group design is proposed based on community views that it would be unethical to deny consenting, eligible fathers access to FIND-F. This is a common approach in early childhood evaluations to increase program access. Both groups will be assessed at three time points: baseline, endpoint, and 6-Month follow-up. After the 6-month follow-up assessment, the waitlist group will be given the opportunity to receive FIND-F.
Each FIND-F session focuses on a specific element of a serve and return interaction, using the edited films to support fathers in learning about that element. The five elements are: (a) Sharing Child's Focus- when the father notices what the child is interested in and puts his attention there too; (b) Supporting and Encouraging- when the father responds to the child's "serve" through acknowledging, soothing, comforting, or praising the child; (c) Naming - when the father provides a word or explanation for what the child is seeing, doing, or feeling; (d) Back and Forth- when the father and child continue interacting in a longer back-and-forth manner; and (e) Endings and Beginnings- when a child signals the end of an activity, a new serve and return interaction begins, and the father follows the child's lead.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Holly Schindler, PhD
- Номер телефона: 206-616-0853
- Электронная почта: hschindl@uw.edu
Места учебы
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Washington
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Seattle, Washington, Соединенные Штаты, 98125
- Рекрутинг
- Akin
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Контакт:
- FIND Program Manager
- Номер телефона: 206-695-3200
- Электронная почта: novina.maree@akinfamily.org
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Identify as a father
- Speak English or Spanish
- Have a child between the ages of 12-36 months who lives with you
- Be enrolled in Akin services
Exclusion Criteria:
- No additional exclusion criteria
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Filming Interactions to Nurture development (FIND)
This group of fathers will receive FIND, a 6-session manualized program.
FIND with fathers is delivered through flexible home visits, targets warm and responsive father-child interactions, and uses video recordings to emphasize each father's parenting strengths in the context of everyday caretaking moments.
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FIND-F is a 6-session manualized program that begins with the home visitor taking a 10-minute video of the father and child engaging in an everyday activity (e.g., playing, having a snack).
Then, that video is carefully edited to emphasize the specific strengths observed in the father-child interactions.
The brief, edited videos are then reviewed with the father the following week.
In reviewing the video clips, the home visitor uses micro-analytic narration, highlighting the frame-by-frame sequence of events that fosters the child's healthy development.
In this way, the goal of FIND-F is to shift the father's perceptions of himself and his child, enabling the father to become increasingly responsive and encouraging.
Home visitors also provide opportunities for fathers to comment and ask questions throughout the video review.
Другие имена:
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Без вмешательства: Waitlist Control
This group will serve as the control group.
After all data is collected, they will be offered FIND.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fathers' Supportive Parenting Practices
Временное ограничение: From enrollment to the end of treatment at 7 weeks
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Fathers' supportive parenting skills will be observed through videotaped father-child interactions.
Fathers will be provided with a standard bag of toys and asked to "share these toys with your child as you normally would."
Each set of toys (one set for pretest, one for endpoint, and one for follow-up) has been carefully selected with input from home visitors about which toys could support interactions across the age range in our study.
The first 10 minutes of the videotaped interactions will be coded using the PICCOLO-D (Dads' Parenting Interactions with Children Checklist of Observations Linked to Outcomes).
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From enrollment to the end of treatment at 7 weeks
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Fathers' Supportive Parenting Practices
Временное ограничение: 6 months after end of treatment
|
Fathers' supportive parenting skills will be observed through videotaped father-child interactions.
Fathers will be provided with a standard bag of toys and asked to "share these toys with your child as you normally would."
Each set of toys (one set for pretest, one for endpoint, and one for follow-up) has been carefully selected with input from home visitors about which toys could support interactions across the age range in our study.
The first 10 minutes of the videotaped interactions will be coded using the PICCOLO-D (Dads' Parenting Interactions with Children Checklist of Observations Linked to Outcomes).
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6 months after end of treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Parenting Stress
Временное ограничение: From enrollment to the end of treatment at 7 weeks
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Fathers' parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) (Loyd & Abidin, 1985).
The PSI-SF asks parents of children birth to 12 years old to indicate their level of agreement or disagreement about 36 statements on a 5-point scale regarding their level of stress, how difficult their child is to manage, and whether parenting fits their expectations.
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From enrollment to the end of treatment at 7 weeks
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Father Identity
Временное ограничение: From enrollment to the end of treatment at 7 weeks
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Fathers' identity related to the fathering role will be measured with The Pie, which instructs fathers to create a graphical representation of their psychological investment in the different aspects of their lives (Cowan & Cowan, 1991).
More specifically, fathers will be asked to list the main roles in their lives and then divide a circle (pie) into pieces so that the size of each piece represents the importance of that role.
In this study, the degrees of the circle that represent fathering or parenting will be recorded.
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From enrollment to the end of treatment at 7 weeks
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Children's Behavior Problems and Social and Emotional Competence
Временное ограничение: From enrollment to the end of treatment at 7 weeks
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We will use the Brief Infant-Toddler Social-Emotional Assessment (BITSEA) to measure both behavior problems and social and emotional competence (Briggs-Gowan, Carter, McCarthy, Augustyn, & Clark, 2013).
The BITSEA is a standardized parent-reported measure of 42 items.
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From enrollment to the end of treatment at 7 weeks
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Father Involvement
Временное ограничение: From enrollment to the end of treatment at 7 weeks
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Fathers' involvement will be captured through the Father Engagement Scale (Dyer et al., 2015).
This measure is for use with fathers of children 12 months to 6 years and asks fathers 10 questions on a 5-point scale about the frequency of their engagement in activities such as playing with toys, hugging their child, talking with their child, and encouraging their child.
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From enrollment to the end of treatment at 7 weeks
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Parenting Stress
Временное ограничение: 6 months after end of treatment
|
Fathers' parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) (Loyd & Abidin, 1985).
The PSI-SF asks parents of children birth to 12 years old to indicate their level of agreement or disagreement about 36 statements on a 5-point scale regarding their level of stress, how difficult their child is to manage, and whether parenting fits their expectations.
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6 months after end of treatment
|
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Father Identity
Временное ограничение: 6 months after end of treatment
|
Fathers' identity related to the fathering role will be measured with The Pie, which instructs fathers to create a graphical representation of their psychological investment in the different aspects of their lives (Cowan & Cowan, 1991).
More specifically, fathers will be asked to list the main roles in their lives and then divide a circle (pie) into pieces so that the size of each piece represents the importance of that role.
In this study, the degrees of the circle that represent fathering or parenting will be recorded.
|
6 months after end of treatment
|
|
Children's Behavior Problems and Social and Emotional Competence
Временное ограничение: 6 months after end of treatment
|
We will use the Brief Infant-Toddler Social-Emotional Assessment (BITSEA) to measure both behavior problems and social and emotional competence (Briggs-Gowan, Carter, McCarthy, Augustyn, & Clark, 2013).
The BITSEA is a standardized parent-reported measure of 42 items.
|
6 months after end of treatment
|
|
Father Involvement
Временное ограничение: 6 months after end of treatment
|
Fathers' involvement will be captured through the Father Engagement Scale (Dyer et al., 2015).
This measure is for use with fathers of children 12 months to 6 years and asks fathers 10 questions on a 5-point scale about the frequency of their engagement in activities such as playing with toys, hugging their child, talking with their child, and encouraging their child.
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6 months after end of treatment
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Holly Schindler, PhD, University of Washington
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
- STUDY00022913
- R01HD117812-01 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Data will be for public use (i.e., not restricted). ICPSR users must agree to the following per ICPSR guidelines:
- The datasets are to be used solely for statistical analysis and reporting aggregated information.
- The confidentiality of research participants is to be guarded in all ways.
- Anything that can potentially breach participants' confidentiality is to be reported promptly to ICPSR.
- The data are not to be redistributed or sold to others without the written agreement of ICPSR.
- The user will inform ICPSR of the use of the data in books, articles, and other forms of publication.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
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. .