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The Family VOICE Study

2019年11月1日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

350

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Maryland
      • Baltimore、Maryland、アメリカ、21201
        • University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

2年~15年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の名前:
  • Patient navigator services
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Family Empowerment Scale
時間枠: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.
Change from baseline to 90 days
Duke-UNC (University of North Carolina) Functional Social Support Questionnaire
時間枠: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.
Change from Baseline to 90 days
Youth Services Survey for Families
時間枠:Change from Baseline to 90 days
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.
Change from Baseline to 90 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Child Behavior Checklist - Brief Problem Monitor
時間枠: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.
Change from Baseline to 90 days
Psychosocial Service Utilization
時間枠:Change from Baseline to 90 days
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.
Change from Baseline to 90 days
Medication Regimen
時間枠: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.
Change from Baseline to 90 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Gloria M Reeves, M.D.、University of Maryland, Baltimore

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年5月1日

一次修了 (実際)

2016年3月31日

研究の完了 (実際)

2016年3月31日

試験登録日

最初に提出

2013年2月27日

QC基準を満たした最初の提出物

2013年3月1日

最初の投稿 (見積もり)

2013年3月5日

学習記録の更新

投稿された最後の更新 (実際)

2019年11月20日

QC基準を満たした最後の更新が送信されました

2019年11月1日

最終確認日

2019年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Family Navigator consultationの臨床試験

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