- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03282071
Joyful Parenting Pilot Project RCT Study
Community-based Mental Wellness Project for Adolescents and Adults: Joyful Parenting Pilot Project RCT Study
Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community.
Targets: Parents aged 12-59 and their family members in Hong Kong.
Methods: Joyful Parenting Pilot Project will adopt the public health and family-focused approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence Generating approach with vigorous study design, both qualitative (e.g. focus groups) and quantitative (e.g. randomised controlled trial), will be used to evaluate the overall programme effectiveness including follow-up of at least one month ("best science"). To ensure the practicability and sustainability of the CBEP, we will engage community partners with strong track records of "best practice" to design, plan, and implement the intervention. This project will use innovative and integrated positive psychology and public health theories and methods to plan brief, simple, and cost-effective intervention.
Significance: By using "best science" in the design and evaluation of intervention programme, and the "best practice" of the partners' skills, experience and strong connection with service targets in the community, the intervention, if proven to be effective, for promoting sharing, mind and enjoyment and enhancing mental wellbeing can be further developed and widely disseminated to and adopted by the practitioners in the health and social service sectors for replication and improvement to benefit the whole population.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Joyful Parenting Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. The Project is funded by Health Care and Promotion Fund of Food and Health Bureau.
Joyful Parenting Pilot Project is organized by the Hong Kong Family Welfare Society and led by the School of Public Health, The University of Hong Kong (HKU). The project will organize two-session interactive talks for parents to promote praise and appreciation, positive thinking, enjoyable parenting and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being; and one family gathering activity to promote and practice quality family communication. One wisdom sharing session will be organized for social workers and service practitioners to promote best practice of community mental wellness project.
The major subjects of the Joyful Parenting Pilot Project RCT Study are 120 parents and at least 240 family members. 4 family service units of Hong Kong Family Welfare Society will either be assigned into intervention groups or wait-list control groups. Cluster Randomized Controlled Trial will be used to evaluate the effectiveness of the intervention programme.
In the study, parents and their family members will be invited to complete questionnaires to measure the behavioral indicators of sharing, mind and enjoyment, and mental well-being and/or invited to attend the focus group to understand the participants' experience during the programme while community partners will be invited to individual in-depth interviews. HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will also be evaluated.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Hong Kong, Гонконг
- Hong Kong Family Welfare Society- North Point Integrated Family Service Centre
-
Hong Kong, Гонконг
- Hong Kong Family Welfare Society- Yau Tong Integrated Family Service Centre
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Parents (major subjects):
- Parents aged 18-59 (including single parents)
- Chinese speaking
- Able to complete questionnaires/ focus groups
Their family members:
- Family members of those parents who have already participated in the Joyful Parenting Pilot Project (Their family members could be children/ adolescents)
- Chinese speaking
- Able to complete questionnaires/ focus groups
Community partners
- Staff of Integrated Family Service Units, under Hong Kong Family Welfare Society in partnership with HKU research team, who organize, plan or implement the project
- Adults aged 18 or above
- Chinese speaking
- Able to complete questionnaires/ individual in-depth interviews
Exclusion Criteria:
- Those who cannot read Chinese
- Those who suffered from severe mental illness
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Joyful Parenting Intervention
Subjects will participate in two-session interactive talks on joyful parenting (a core session intervention and booster intervention) and one family gathering activity; questionnaire evaluation will be conducted at baseline, post-session,1 month and 3 month after core session.
|
|
|
Без вмешательства: Control
No intervention will be provided to control groups during study period.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Sharing (Praise), Mind (Appreciation) and Enjoyment (SME) Related Behaviours
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
|
Outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours from baseline to three-month after baseline. Praise: 3-item (range: 0-21). Higher scores mean a better outcome. Appreciation: 2-item (range: 0-14). Higher scores mean a better outcome. Enjoyment: 2-item (range: 0-14). Higher scores mean a better outcome. |
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow-up after baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in Subjective Happiness From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Subjective Happiness Scale (4 items) (1-7): higher scores mean a better outcome.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Mental Well-being From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Validated Chinese version of 7-item Warwick Edinburgh Well-being Scale (7-35): higher scores indicated higher level of wellbeing.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Family Relationship From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Respondents rated each item from 0 (no understanding / intimacy / communication at all with family members) to 10 (full understanding / intimacy / communication with family members), resulting in a total score of 0-30, with higher scores indicating better family relationship.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Personal and Family Health From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Respondents rated each item from 0 (not at all healthy) to 10 (very healthy), with higher scores indicating higher level of personal/family health.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Personal and Family Happiness From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Respondents rated each item from 0 (not at all happy) to 10 (very happy), with higher scores indicating higher level of personal/family happiness.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Family Harmony From Baseline to Three-month After Baseline
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Respondents rated each item from 0 (not at all harmonious) to 10 (very harmonious), with higher scores indicating higher level of family harmony.
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Changes in Knowledge and Perception of Mixed Anxiety and Depressive Disorders
Временное ограничение: T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
The knowledge and understandings of MADD was self-developed to assess the level of awareness of the MADD symptoms ("I know the symptoms of MADD", range 0 to 10), intention to seek help ("I will talk to families or friends when I have emotional disturbance", range 0-10), self-efficacy of help seeking ("I know how to seek help when I have emotional disturbance", range 0-10), and understanding of the MADD definition ("MADD refers to the condition when both anxiety and depression are diagnosed", yes/no/uncertain).
|
T1: baseline; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
|
Satisfaction Towards Joyful Parenting Intervention Programme
Временное ограничение: T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Satisfaction towards programme will be assessed by program evaluation measures: rated on a 0-10 scale, with "0" indicating "unsatisfied" and "10" indicating "satisfied".
|
T2: after 1st talk; T3: 1-month follow-up after baseline; T4: 3-month follow up after baseline
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Yuying Sun, The University of Hong Kong
Публикации и полезные ссылки
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
Ключевые слова
Другие идентификационные номера исследования
- SPH-MHP-FWS01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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.
продукт, произведенный в США и экспортированный из 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. .
Клинические исследования Joyful Parenting Intervention
-
Children's Hospital Medical Center, CincinnatiРекрутингОтношения между родителями и детьми | Воспитание детей | Проблема поведения ребенка | НедоношенныйСоединенные Штаты
-
Stockholm UniversityYale University; University of Chile; EDI Global; Elizabeth Glaser Pediatric AIDS Foundation... и другие соавторыЗавершенныйВоспитание детей | Раннее развитие ребенкаТанзания
-
Brigham and Women's HospitalNational Institute on Aging (NIA)ЗавершенныйРевматические заболевания | Красная волчанка, системная | Приверженность, лекарства | ПодаграСоединенные Штаты
-
University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)ЗавершенныйПрактика воспитания | Поведенческие и эмоциональные трудности ребенкаПанама
-
Dalhousie UniversityЗавершенныйБеспокойство | Проблемы со сномКанада
-
Meghan MarsacChildren's Hospital of PhiladelphiaЗавершенный
-
Seton Healthcare FamilyUniversity of Texas at AustinЗавершенныйКачество жизни | Хроническое заболевание | Хроническое заболеваниеСоединенные Штаты
-
University Medical Center GroningenGGZ Drenthe Mental Health InstitutionРекрутингСердечно-сосудистый риск | Депрессия, униполярная | Депрессия, биполярное расстройствоНидерланды
-
Hospital Clinic of BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer; University of BarcelonaЗавершенныйЗаболевания печени | Неалкогольная жировая болезнь печени | Образ жизни, ЗдоровыйИспания
-
Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute... и другие соавторыНеизвестныйТравматическое повреждение мозгаСоединенные Штаты