The Family VOICE Study
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
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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 |
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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:
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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.
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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 |
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Family Empowerment Scale
時間枠:Change from baseline to 90 days
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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
時間枠:Change from Baseline to 90 days
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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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Child Behavior Checklist - Brief Problem Monitor
時間枠:Change from Baseline to 90 days
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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
時間枠: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
時間枠:Change from Baseline to 90 days
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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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協力者と研究者
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
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HP-00054913
- 1300476 (その他の識別子:Patient Centered Outcome Research Institute (PCORI))
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?
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。
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