Single Session Consultation for Parents (SSC)
8 сентября 2021 г. обновлено: Dr. Anil Chacko, New York University
Single-Session Consultation (SSC) is a rapidly provided, low-intensity, goal-directed counseling service used for treatment of diverse mental health problems. Research on SSC suggests that, for some clients, a single session of counseling (60 minutes) may help reduce clinical distress.
Despite its benefits, SSC has yet to be evaluated as an alternative for parents (18+) of school-age children (5-12 years old) in the United States with elevated stress levels.
The current research aims to evaluate SSC's feasibility, acceptability, and efficacy as an intervention for this population.
First, perceived acceptability (i.e., parents' participation and successful completion, reschedules, and/or cancellations), usefulness, and client satisfaction will be examined. The investigators will also evaluate whether mechanisms of change (e.g, hope, agency), parental (e.g, stress, mental health), and child (e.g, behavior) outcomes, are improved following the SSC.
The investigators expect SSC to be acceptable, for clients to find SSC to be useful, to be satisfied, and experience an increase in hope and agency after the SSC and hypothesize a reduction in stress levels and improvement in mental health among parents. However, the investigators believe behavior outcomes for the child will remain unchanged.
The investigators will recruit parents via online advertisement on social media. Potential participants will complete a screener through Qualtrics to determine eligibility, which includes location in the United States, age (18+), child's age (5-12 years old), preferred language, child's legal guardianship, technology access, and stress levels. Once eligible, participants will provide consent and make an appointment for their SSC.
The 60-minutes-session will be conducted using HIPAA complaint NYU Zoom with Study Consultants. Parents will complete assessments of parental stress, parental mental health, and child behavior to assess mechanisms (i.e., hope, agency) outcomes and measures of usefulness and satisfaction prior and post the SSC, and another 2-week follow-up questionnaire to monitor progress.
Sessions will be recorded for supervision and treatment fidelity purposes. Upon completion, parents will receive an Action Plan, a written record of the discussion, recommendations, and resources.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
40
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: Zuania Capo, MA
- Номер телефона: 787-510-1279
- Электронная почта: zc490@nyu.edu
Учебное резервное копирование контактов
- Имя: Nicole Lui, BS
- Номер телефона: 718-406-3960
- Электронная почта: nvl221@nyu.edu
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
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Adult parents (18+ years old) who are legal guardians of their school-age children (5 to 12 years old)
- Must have elevated stress levels based on validated measures obtained through parent self-report
- Parent must reside in the United States
- Must be English dominant
- Can access video-based Zoom conference
Exclusion Criteria:
- Parent has significant cognitive delays that prohibit involvement in SSC
- Parent expresses significant personal mental health challenges/child abuse during SSC that warrant immediate discontinuation from SSC.
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: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Single Arm Study
The intervention will consist of one 60-minute long session conducted through NYU ZOOM.
Each session will be between one parent and one study consultant.
The session is goal-oriented and solution-focused.
During the SSC, consultants will identify the participant's hope for the session and a specific modifiable goal.
From this, the consultant will discuss the "smallest-possible step" participants can take toward overcoming their identified problem and work together in creating an Action Plan, which will present three specific actions the participant can take to accomplishing the session's established goals.
Following completion of the two-week follow-up assessment, additional resources personalized to participants will also be provided (i.e., referrals for further services and online resources for parents/children).
Ultimately, this intervention is a way to potentially jumpstart progress and facilitate hope and agency.
|
Single-Session Consultation (SSC) is a low-intensity, goal-directed, solution-focused counseling service used for treatment of mental health problems.
The intervention consists of a 60-minute session conducted through NYU ZOOM, a HIPAA compliant teleconferencing platform.
Sessions will be conducted between a parent and a study consultant.
The consultant will 1) identify the participant's specific modifiable goal (and associated "hope"); 2) the "smallest-possible step" taken to overcome their problem; and 3) work collaboratively in creating an Action Plan, drawing on their inner abilities and external resources.
This intervention does not act as therapy but instead, to potentially jumpstart progress and facilitate hope and agency.
Following completion, participants will receive their Action Plan.
Additional personalized resources will be provided following completion of the follow-up assessment, which includes referrals for further services and online resources.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Parenting Stress [Fragile Families Aggravation in Parenting Scale (FFAPS)] from Screener to Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Screener, Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The Fragile Families Aggravation in Parenting Scale is a four-item scale completed by parents to assess parenting stress.
Items are rated on a scale from strongly agree to strongly disagree, with greater agreement of items relating to higher levels of stress.
The FFAPS has been used in longitudinal studies of parenting and family functioning in the United States and is psychometrically validated for parents of preschool-school-age children.
This measure will be used to screen for participant eligibility and as an outcome measure.
|
Screener, Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in Positive and Negative Affect Schedule Short Form (PANAS-SF) from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The PANAS -SF is a 10-item self-report measure that assesses positive affect and negative affect in adults.
Scores range from 1 (very slightly or not at all) to 5 (extremely).
The items correlate with more specific measures of adult mood and anxiety and is often used in research with community samples to assess mental health functioning.
The PANAS-SF is psychometrically-validated (Thomas et al., 2007).
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in Family Empowerment Scale (family subscale) from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The Family Empowerment Scale (FES) is a parent-report measure to specifically assess empowerment in families with children with emotional/behavioral challenges.
The "About Your Family" subscale is a six-item subscale that focuses on parents' confidence in managing their family/child.
Scores range from 1 (never) to 5 (very often).
Higher total scores indicate a higher level of parent empowerment.
The FES has been used in intervention studies with parents/families and has strong psychometric properties.
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in Readiness for Change Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The Readiness for Change Ruler is a three-item parent-report of parents motivation for change.
The ruler is based on the motivational interviewing literature and has been adapted for use for a specific population and research questions.
Scores range from 0 (not at all confident/important/ready) to 10 (completely confident/important/ready), with scores above a 5 showing that the person is willing to consider change.
The ruler was adapted for use with parents who have stress related to parenting.
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in Beck Hopelessness Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The Beck Hopelessness Scale is a four-item self-report measure assessing adult hopelessness about the future.
Scores range from 1 (absolutely disagree) to 4 (absolutely agree), with higher total scores equating to greater levels of hopelessness.
The Beck Hopelessness scale is psychometrically valid.
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in State Hope Scale from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The State Hope Scale offers a brief, internally consistent, and valid self-report measure of ongoing goal-directed thinking of adults.
Scores range from 1 (definitely false) to 8 (definitely true), with higher total scores equating to greater levels of agency.
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Change in Behavior and Feelings Questionnaire from Baseline to Within 2 Hours of the Intervention to 2-Week Follow Up
Временное ограничение: Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
The Behavior and Feelings Survey (BFS) is a brief, 12-item rating scale designed to facilitate efficient progress-monitoring during youth psychotherapy.
It was developed and evaluated in four samples, among youths ages 7-15 years, with results demonstrating a robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity, and utility for tracking change during youth psychotherapy (Weisz et al., 2019).
The BFS offers caregiver-report forms.
Items are rated on a scale from 0 (not a problem) to 4 (a very big problem).
Three scale scores can be derived: Internalizing Problems (sum of items 1-6), Externalizing Problems (sum of items 7-12), and Total Problems (sum of items 1-12).
|
Baseline, Within 2 Hours of Intervention, and 2-Week Follow Up
|
|
Strengths and Difficulties Questionnaire (SDQ)
Временное ограничение: Screener
|
The Strengths and Difficulties Questionnaire (SDQ) is a short behavioral screening questionnaire for children aged 3 to 16.
The questionnaire is used to assess children's mental health and can be completed by children and young people themselves, by their parents, or by their teachers.
Scores range between not true to somewhat true to certainly true.
For this study, parents will complete the 25 attributes/questions from the SDQ.
These 25 items are divided between 5 scales: emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behavior (5 items).
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Screener
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
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 (Ожидаемый)
1 октября 2021 г.
Первичное завершение (Ожидаемый)
1 февраля 2022 г.
Завершение исследования (Ожидаемый)
1 мая 2022 г.
Даты регистрации исследования
Первый отправленный
24 августа 2021 г.
Впервые представлено, что соответствует критериям контроля качества
8 сентября 2021 г.
Первый опубликованный (Действительный)
17 сентября 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 сентября 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 сентября 2021 г.
Последняя проверка
1 сентября 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB-FY2021-5325
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. .