Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy (PSC-TF-CBT)to Reduce Trauma Symptoms and Negative Mental Health Sequelae
27 августа 2026 г. обновлено: Funlola Are, The University of Texas Health Science Center, Houston
Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy to Reduce Trauma Symptoms and Negative Mental Health Sequelae
The purpose of this study is to evaluating the feasibility of delivering a trauma-focused intervention among children with elevated traumatic stress symptoms in primary care
Обзор исследования
Тип исследования
Интервенционный
Регистрация (Оцененный)
30
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Funlola G Are, PhD
- Номер телефона: (713) 486-2700
- Электронная почта: Funlola.G.Are@uth.tmc.edu
Учебное резервное копирование контактов
- Имя: Kofoworola Bombata
- Электронная почта: Kofoworola.Bombata@uth.tmc.edu
Места учебы
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- The University of Texas Health Science Center at Houston
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Контакт:
- Kofoworola Bombata
- Электронная почта: Kofoworola.Bombata@uth.tmc.edu
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Контакт:
- Funlola G Are, PhD
- Номер телефона: 713-486-2700
- Электронная почта: Funlola.G.Are@uth.tmc.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
- Ребенок
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- able to read or understand English
Exclusion Criteria:
- Currently receiving mental health treatment elsewhere
Clinical exclusion criteria:
- Evidence of active suicidality
- Presence of psychotic symptoms
Severe psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as:
- Score ≥ 40 on the child-report measure, or
- Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments
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: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: PSC-TF-CBT
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The intervention is a stepped-care adaptation of Trauma-Focused Cognitive Behavioral Therapy (PSC-TF-CBT) delivered within pediatric primary care.
Treatment intensity is matched to each participant's individual clinical needs, with participants receiving lower-intensity intervention components initially and progressing to more intensive trauma-focused treatment as clinically indicated.
PSC-TF-CBT incorporates trauma-focused cognitive behavioral therapy strategies for youth and includes caregiver involvement.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility as assessed by the number of participants recruited
Временное ограничение: From baseline to end of study (30 weeks form baseline)
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From baseline to end of study (30 weeks form baseline)
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Feasibility as assessed by the number of participants enrolled in the study
Временное ограничение: end of study (30 weeks form baseline)
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end of study (30 weeks form baseline)
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Feasibility as assessed by the number of participants retained in the study
Временное ограничение: end of study (30 weeks form baseline)
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Retained is described as participants who enroll in the study and remain enrolled through the study endpoint/final.
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end of study (30 weeks form baseline)
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Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant
Временное ограничение: From baseline to end of study (30 weeks form baseline)
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From baseline to end of study (30 weeks form baseline)
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Feasibility as assessed by number of participants that completed the intervention
Временное ограничение: end of study (30 weeks from baseline)
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end of study (30 weeks from baseline)
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Change in acceptability by youth as assessed by participant satisfaction questionnaires
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Satisfaction will be assessed using a 10-item questionnaire.
Participants will respond to each item with either "Agree" or "Disagree."
The total number of "Agree" responses will be calculated, resulting in a total score ranging from 0 to 10.
A higher number of "Agree" responses indicates greater satisfaction.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability by caregiver as assessed by participant satisfaction questionnaires
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 13 item questionnaire and each is scored from 1(very dissatisfied) to 7 (Very satisfied) for a score range of 13-91, higher scores indicating better outcome
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability of the intervention by the youth as assessed by qualitative exit interviews
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability of the intervention by the caregiver as assessed by qualitative exit interviews
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Child traumatic stress symptoms as assessed by the Child Trauma Screen (CTS)
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 10 item questionnaire divided into 2 components: Four items assess exposure to potentially traumatic events using a yes/no response format, and six items assess PTSD-related reactions using a 4-point response scale scored from 0 to 3. The six reaction items are summed to produce a Reactions Total score ranging from 0 to 18, with higher scores indicating greater traumatic stress symptom severity. A Reactions Total score of ≥6 indicates a high likelihood of clinically significant PTSD symptoms |
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), (parent report )
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (child's self-report)
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
|
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (parent report)
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in emotional and behavioral problems as assessed by the Pediatric Symptom Checklist-17 (PSC-17)
Временное ограничение: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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The Pediatric Symptom Checklist-17 (PSC-17) is a 17-item screening measure of psychosocial, emotional, and behavioral problems in children and adolescents.
Each item is rated on a 3-point scale from 0 (Never) to 2 (Often).
Item scores are summed to generate a Total Problems Score, ranging from 0 to 34, with higher scores indicating greater emotional and behavioral difficulties.
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 4-item implementation outcome measure rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Scores will be calculated by averaging item responses , with higher scores indicating greater perceived appropriateness.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability as assessed by the Acceptability of Intervention Measure (AIM)
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
The four item scores are averaged to generate an overall AIM score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Feasibility as assessed by the Feasibility of Intervention Measure (FIM).
Временное ограничение: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree) for a maximum score range of 1-20,with higher scores indicating greater perceived feasibility of the intervention.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Funlola G Are, The University of Texas Health Science Center, Houston
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 (Оцененный)
31 августа 2026 г.
Первичное завершение (Оцененный)
1 июля 2027 г.
Завершение исследования (Оцененный)
1 августа 2027 г.
Даты регистрации исследования
Первый отправленный
27 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
27 августа 2026 г.
Первый опубликованный (Действительный)
1 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HSC-MS-26-0466
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
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. .