The Family VOICE Study
1 ноября 2019 г. обновлено: Gloria Reeves, University of Maryland, Baltimore
The Family VOICE Study (Value, Information, Community Support, and Experience): A Randomized Trial of Family Navigator Services Versus Usual Care for Care of Young Children Treated With Antipsychotic Medication
Family centered mental health treatment with children values and supports the role of parents in their child's recovery.
However, medications are often the primary focus in community treatment, even in preschool age youth, with increasing use of antipsychotic medication for serious mood and behavior problems.
Although medication may be necessary to address safety issues (such as severe aggression) it can cause serious side effects, such as obesity, and medication only does not follow recommended care for these types of problems.
Psychosocial treatments are highly recommended (e.g.
Programs that coach empower parents to manage their child's difficult behaviors) as part of comprehensive child treatment.
Parent involvement in psychosocial treatment has clear benefits for their child's mental health, and unlike medication, the effects can last long after treatment is completed.
However, problems related to access (e.g.
long waiting lists) and use (e.g.
parent mistrust mental health services) of services are common.
Maryland, like other states, has developed a system to improve medication safety by reviewing health information about the child to determine if the treatment is appropriate.
This reduces unnecessary medication treatment and ensures children have adequate health screening before starting any treatment.
Those approved for medication have moderate-severe mental health problems, which supports their need for comprehensive (medication and psychosocial) treatment, instead of medication only.
In this study, investigators partner with parents/family advocates, child-serving agencies, and health providers to develop a Family Navigator (FN) Service to link with this medication program.
A FN is an individual who has cared for their own child with mental illness.
The FN supports parents, provide information on psychosocial treatment options, and address barriers to using services.
The goals of this program are to improve use of psychosocial services, and to improve parent empowerment, support, and satisfaction with their child's mental health treatment.
The investigators also expect that the FN Service will improve the child's overall mental health and reduce the likelihood of a medication dose increase or another medication added during the initial treatment period.
The FN Service is provided for parents of public insured children ages 3-15 years newly approved for antipsychotic medication treatment.
The FN Services will be provided by phone, which supports families in both rural and urban settings.
The investigators' long term goal is to develop a FN program that strongly supports Family-centered treatment of children and can be used to help families in other underserved areas beyond Maryland.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
Background: Emerging data on serious antipsychotic medication side effects (e.g.
new onset diabetes)has heightened concerns about sharp increases in "off label" pediatric antipsychotic treatment of mood/behavioral disorders, and led to increased scrutiny of pediatric mental health treatment.
Several states are developing antipsychotic medication pre-authorization programs to reduce inappropriate or unsafe prescribing.
This Healthcare system change, however, fails to address a critical underlying problem that parents are not effectively engaged to utilize non-medication treatments and serve an active role in their child's mental health recovery.
Psychosocial treatments (e.g.
parenting skills training to manage aggressive behaviors) are evidence-based interventions that are poorly utilized in community care.
The Maryland Medicaid program developed a pediatric Antipsychotic Pre-Authorization Program that requires providers to make at least one psychosocial treatment referral in order to obtain medication approval.
This program was shaped by strong input from parents, health experts, and child serving agency administrators to promote psychosocial treatment referral, but it does not provide any Family-centered services to improve treatment utilization.
Objectives: We propose to link the Antipsychotic Pre-Authorization Program with a Family Navigator Service.
The investigators will examine if Navigator Services improve parent empowerment, support, and satisfaction with child services.
The investigators will also assess if Navigator Services are associated with improved psychosocial service utilization, improved child functioning, and lower likelihood of medication increases (higher dose or addition of another medication).
The investigators' long term objective is to develop a Family Navigator model that is highly portable, amenable for use in underserved areas, addresses the needs of low income families with young children, and promotes evidence-based mental health care.
Methods: The investigators will conduct a randomized trial of a telephone Family Navigator Service versus usual care for 240 Medicaid insured youth 10 years old who are approved for antipsychotic medication treatment.
The Family Navigator is a parent who has experienced their own child's mental illness.
Navigators will provide support, information on psychosocial treatment options, and options to address barriers to care.
The investigators will assess family-centered outcomes at baseline and 90 days (medication re-authorization).
The investigators will use generalized linear mixed effects models with the appropriate link functions to assess whether there is a significant difference in improvement from baseline to the post-treatment assessment on the outcome variables between the Family Navigator condition and treatment as usual condition.
A significant interaction between time and study condition would support the hypothesis that a Family Navigator will improve parent and child outcomes.
Тип исследования
Интервенционный
Регистрация (Действительный)
350
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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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21201
- University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
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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 2 года до 15 лет (Ребенок)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
Child 2 to 15 years old who has been approved by the Maryland Medicaid program for treatment with an antipsychotic medication.
Exclusion Criteria:
Department of social services custody
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: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Family Navigator Consultation
This group of parents will be contacted by a Family Navigator to assist them in accessing psychosocial resources based on their child and family needs. Components of this intervention are the following: (1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan. |
Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following: (1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan.
Другие имена:
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Без вмешательства: Usual Care
No specific study intervention is provided to this group of parents.
This control group will received the usual care that they have been receiving from their child's providers.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Family Empowerment Scale
Временное ограничение: Change from baseline to 90 days
|
This 34-item, Likert scale with scores ranging from 1 (never) to 5 (very often) which measures parent empowerment related to caring for their child with special needs.
Higher scores indicate a greater sense of parental empowerment in caring for their child, interacting with the services system and contributing to the community.
The sub scales have demonstrated good reliability and validity, and provide comprehensive information about empowerment, including attitudes, knowledge, and behaviors.
A composite score was calculated for each participant with the range 1-5 (1 never to 5 very often)based on the average of their item scores with higher scores indicating better outcomes.
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Change from baseline to 90 days
|
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Duke-UNC (University of North Carolina) Functional Social Support Questionnaire
Временное ограничение: Change from Baseline to 90 days
|
This 14 item questionnaire assesses confidant ("e.g.
"I get chances to talk to someone I trust about family problems."),
affective ("People care what happens to me."), and instrumental ("I can get help when I need transportation support.").
In a validation sample, the measure was found to have good internal consistency and it correlated with related domains of psychosocial functioning in expected directions.
This measure has been widely used to assess social support among both identified medical and mental health patients as well as their family members.
A composite score was calculated for each participant with the range 1-5 (1 As much as I would like to 5 Much less than I would like) based on the average of their item scores.
The range of scores is from 1-5 with lower scores indicating better functional social support.
Subscales were not analyzed.
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Change from Baseline to 90 days
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Youth Services Survey for Families
Временное ограничение: Change from Baseline to 90 days
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This 26-item questionnaire specifically targets parents' satisfaction with children's mental health services.
The measure assesses five domains of parent satisfaction: cultural sensitivity, access, treatment participation, appropriateness, and outcome.
This measure has been adopted by several State mental health systems to evaluate parent satisfaction with child services.
A composite score was calculated for each participant with the range 1-5 (1 Strongly Disagree to 5 Strongly Agree) based on the average of their item scores.
Range of scores is from 1-5 with higher scores indicating better functional social support.
Subscales were not analyzed.
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Change from Baseline to 90 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Child Behavior Checklist - Brief Problem Monitor
Временное ограничение: Change from Baseline to 90 days
|
We will use the preschool (ages 1 ½-5) and school age (6-12) versions of this measure, which asks parents to rate items about behavioral and emotional problems on a 0-2 scale.
Both versions provide a Total Problem Score.
These measures have been widely used in pediatric mental health research.
The Brief Problem Monitor provides T scores for the total problem score and it ranges from 0-80, with higher T scores indicating more mental health difficulties.
Subscales of this measure were not analyzed.
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Change from Baseline to 90 days
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Psychosocial Service Utilization
Временное ограничение: Change from Baseline to 90 days
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We will utilize total Medicaid claims data for any psychosocial services claims (e.g.
individual, family, or group psychotherapy; parenting groups) to collect information on services used in the 90 days prior to the baseline and over the 90 days of participant enrollment in the study.
Participants were considered to have received psychosocial claims (dichotomous Yes/No) if they received any individual, family, or group psychotherapy in the 90 days prior and during the study period.
Higher numbers indicate more participants received at least 1 psychosocial service claim.
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Change from Baseline to 90 days
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Medication Regimen
Временное ограничение: Change from Baseline to 90 days
|
We will utilize Medicaid pharmacy prescription data collect information at baseline and 90 days on the name and dose of all psychiatric medications prescribed at those time points.
Participants were designated increase or no increase in their dosage of antipsychotic medication (i.e., dichotomous Yes/No) over the 90 day intervention period.
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Change from Baseline to 90 days
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Gloria M Reeves, M.D., University of Maryland, Baltimore
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)
1 мая 2013 г.
Первичное завершение (Действительный)
31 марта 2016 г.
Завершение исследования (Действительный)
31 марта 2016 г.
Даты регистрации исследования
Первый отправленный
27 февраля 2013 г.
Впервые представлено, что соответствует критериям контроля качества
1 марта 2013 г.
Первый опубликованный (Оценивать)
5 марта 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 ноября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 ноября 2019 г.
Последняя проверка
1 ноября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HP-00054913
- 1300476 (Другой идентификатор: Patient Centered Outcome Research Institute (PCORI))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .