Promoting Treatment Access Following Pediatric Primary Care Depression Screening
5 марта 2020 г. обновлено: Jessica Schleider, Stony Brook University
Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality.
The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment.
Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services.
Single-session interventions (SSIs) may help forward these goals.
SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale.
Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs.
One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health.
This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening.
Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI).
The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months.
Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.
Обзор исследования
Статус
Неизвестный
Условия
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
246
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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New York
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Stony Brook, New York, Соединенные Штаты, 11794-2500
- Рекрутинг
- Stony Brook University
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Контакт:
- Jessica L Schleider, PhD
- Номер телефона: 631-632-4131
- Электронная почта: jessica.schleider@stonybrook.edu
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 11 лет до 16 лет (Ребенок)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment
- Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook University-affiliated clinics participating in this study
- Parent and youth are comfortable with reading and writing in English
- Parent and youth are comfortable with online activity
Exclusion Criteria:
- Parent or youth is not comfortable reading and/or writing in English
- Parent or youth is not comfortable with online activity
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Online Programs + Information/Psychoeducation/Referral (IPR)
Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR.
The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.
In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth.
After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information.
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Online, 15-minute self-administered program for parents
Online, 30 minute self-administered program for youths
Другие имена:
Usual care at pediatric primary care clinics participating in this study
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Плацебо Компаратор: Information/Psychoeducation/Referral (IPR; usual care control)
Information, Psychoeducation and Referral (IPR) represents usual care in the Stony Brook University Hospital's Pediatric Primary Care Division.
Families of a youth with elevated MD symptoms during a PC visit receive a folder containing informational materials about the nature of depression and referrals to providers in their area.
All families in this study will receive PC-based IPR.
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Usual care at pediatric primary care clinics participating in this study
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mental Health Treatment-Seeking Behavior Checklist
Временное ограничение: Baseline to 3-month follow-up
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At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency.
Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period).
At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.'
At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'
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Baseline to 3-month follow-up
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Change in Children's Depression Inventory 2 - Youth Report Total Score
Временное ограничение: Baseline to 3-month follow-up.
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Change in youth reported depressive symptoms, total score derived from 28-item CDI-2.
Scores range from 0-56, with higher scores indicating higher levels of depression.
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Baseline to 3-month follow-up.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Pediatric Symptom Checklist - Youth-Report Total score
Временное ограничение: Baseline to 3-month follow-up.
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Youth-report measure of overall youth psychopathology.
Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms.
Scores range from 0 - 70.
Higher scores indicate higher overall symptom severity.
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Baseline to 3-month follow-up.
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Change in Pediatric Symptom Checklist- Parent Report Total score
Временное ограничение: Baseline to 3-month follow-up.
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Youth-report measure of overall youth psychopathology.
Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms.
Scores range from 0 - 70.
Higher scores indicate higher overall symptom severity.
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Baseline to 3-month follow-up.
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Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
Временное ограничение: Baseline to 3-month follow-up.
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Parent-report measure of overall youth psychopathology.
Parents rate 5 items on a 0-2 scale reflecting internalizing symptoms in their child.
Scores range from 0-10.
Higher scores indicate higher overall symptom severity.
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Baseline to 3-month follow-up.
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Change in Beck Hopelessness Scale - 4 (Youth Report)
Временное ограничение: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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Respondents (youths) report agreement with 4 items indicating levels of hopelessness about the future.
Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.
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Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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Change in Beck Hopelessness Scale - 4 (Parent Report)
Временное ограничение: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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Respondents (parents) report agreement with 4 items indicating levels of hopelessness about the future.
Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.
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Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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Change in Brief Symptom Inventory - 18
Временное ограничение: Baseline to 3-month follow-up
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The Brief Symptom Inventory-18 (BSI-18) assesses self reported parent psychopathology and distress.
Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale.
The total sum score yields an additional total distress score (range: 0-72).
Higher scores indicate higher levels of overall psychological distress.
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Baseline to 3-month follow-up
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Change in Barriers to Accessing Care Evaluation (BACE)
Временное ограничение: Baseline to 3-month follow-up
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Parents rate the 30 items on a 0-3 scale indicating the degree to which various beliefs, concerns, circumstances, and logistical difficulties have stopped, delayed or discouraged them from getting professional care for their child's mental health problem.
Higher total scores indicate greater perceived barriers to care.
Scores range from 0-90, with higher scores indicating more overall barriers to accessing mental health care for their child.
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Baseline to 3-month follow-up
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Change in Attitudes Toward Therapy Scale - Parent
Временное ограничение: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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One-item measure used to assess parents' perceptions that therapy/counseling would be useful in reducing their child's emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10).
Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems.
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Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
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Mental Health Treatment Access at 3-month follow-up
Временное ограничение: 3-month follow-up
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Parents will indicate (yes/no) whether their child has received (a) new and/or (b) continuing school-based, outpatient, or other mental health-related services since the child's recent PC appointment (at baseline) and since the baseline assessment (at 3-month follow-up).
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3-month follow-up
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Change in Perceived Stress Scale
Временное ограничение: Baseline to 3-month follow-up
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The PSS is a well-validated measure of the degree to which situations in one's life are appraised as stressful, unpredictable, and uncontrollable.
Higher total scores indicate greater overall perceived stress.
The scale includes 10 items rated on a 0-4 scales, and scores range from 0-40.
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Baseline to 3-month follow-up
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Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
Временное ограничение: Baseline to 3-month follow-up.
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Youth-report measure of youth depressive symptoms.
Youth rate 5 items reflecting internalizing symptoms on a scale from 0-2.
Total scores range from 0 to 10. Higher scores indicate higher internalizing symptom severity.
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Baseline to 3-month follow-up.
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Change in Children's Depression Inventory 2 - Parent Report total score
Временное ограничение: Baseline to 3-month follow-up.
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Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2.
Scores range from 0-54, and higher scores indicate greater youth depression severity.
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Baseline to 3-month follow-up.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in implicit theories of emotion scale, parent-report
Временное ограничение: Baseline to immediate-post-online intervention (active intervention group only)
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This measure will be used as a manipulation check for parents assigned to the active intervention condition.
Parents will be asked to report the degree to which they view emotions as malleable (versus immutable) at pre- and post-intervention using a previously validated, 4-item assessment of emotion mindsets in adults.
Four items are rated using a 1-to-6 Likert scale.
Higher mean scores on these items indicate a stronger fixed emotion mindset, a lower scores, a stronger growth emotion mindset (range: 1-).
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Baseline to immediate-post-online intervention (active intervention group only)
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Change in Implicit Theories of Personality Questionnaire, youth-report
Временное ограничение: Baseline to immediate-post-online intervention (active intervention group only)
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This measure will be used as a manipulation check for youths assigned to the active intervention condition.
Respondents rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-6 Likert scale (e.g.
"Your personality is something about you that you can't change very much").
Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-6).
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Baseline to immediate-post-online intervention (active intervention group only)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
15 января 2020 г.
Первичное завершение (Ожидаемый)
30 апреля 2021 г.
Завершение исследования (Ожидаемый)
30 августа 2021 г.
Даты регистрации исследования
Первый отправленный
20 июля 2019 г.
Впервые представлено, что соответствует критериям контроля качества
23 июля 2019 г.
Первый опубликованный (Действительный)
24 июля 2019 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
6 марта 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
5 марта 2020 г.
Последняя проверка
1 марта 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB2019-00241
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
De-identified individual-level participant data will be made publicly available on Open Science Framework upon completion of the grant period (August 2021).
Сроки обмена IPD
Study protocol and a statistical analysis plan have been uploaded with this pre-registration.
Критерии совместного доступа к IPD
Materials will be publicly available on clinicaltrials.gov.
IPD will be made publicly available on Open Science Framework upon completion of the grant period (August 2021)
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .