- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01804582
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Family Empowerment Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child Behavior Checklist - Brief Problem Monitor
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Gloria M Reeves, M.D., University of Maryland, Baltimore
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HP-00054913
- 1300476 (Altro identificatore: Patient Centered Outcome Research Institute (PCORI))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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