- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
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No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Empowerment Scale
Time Frame: 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
|
Duke-UNC (University of North Carolina) Functional Social Support Questionnaire
Time Frame: 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
|
Youth Services Survey for Families
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Behavior Checklist - Brief Problem Monitor
Time Frame: 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
Time Frame: 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.
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Change from Baseline to 90 days
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Medication Regimen
Time Frame: 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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Collaborators and Investigators
Investigators
- Principal Investigator: Gloria M Reeves, M.D., University of Maryland, Baltimore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00054913
- 1300476 (Other Identifier: Patient Centered Outcome Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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