The Family VOICE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01804582
Recruitment Status : Unknown
Verified December 2015 by Gloria Reeves, University of Maryland.
Recruitment status was:  Enrolling by invitation
First Posted : March 5, 2013
Last Update Posted : December 10, 2015
Information provided by (Responsible Party):
Gloria Reeves, University of Maryland

Brief Summary:
Family-centered mental health treatment of children values and supports the role of parents in their child's recovery. However, medications are often the primary focus in community treatment. Young children, even preschool-age youth, are increasingly being treated with antipsychotic medication for serious mood and behavior problems. This medication may be necessary to address safety issues (such as severe aggression), but it can cause serious side effects, such as obesity. Also, medication-only treatment does not follow recommended care for these types of problems. Psychosocial treatments (for example, programs that coach and empower parents to manage their child's difficult behaviors) are highly recommended as part of comprehensive (medication and psychosocial) 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 (for example, long waiting lists) and use (for example, parent mistrust of 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 review reduces unnecessary medication treatment and makes sure that children have adequate health screening before starting any treatment. Children who are approved for medication treatment have moderate-to-severe mental health problems, which supports their need for comprehensive (medication and psychosocial)treatment, instead of medication-only treatment. In this study, investigators are partnering with parents/family advocates, child-serving agencies, and health providers to develop a Family Navigator Service to link with this medication program. Family Navigators are individuals who have cared for their own child with mental illness. The navigators will support 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 Navigator Service will improve the child's overall mental health and reduce the likelihood that he/she will need a medication dose increase or another medication added over the initial treatment period. The Navigator Service will be provided for parents of public insured children who are 10 years old and have just been approved for antipsychotic medication treatment. The Navigator Services will be provided by phone, so this service can support families in both rural and urban settings. The investigators' long term goal is to develop a Family Navigator program that strongly supports Family-centered treatment of children and can be used to help families in other underserved areas beyond Maryland.

Condition or disease Intervention/treatment Phase
Autism Aggression Bipolar Disorder Psychotic Disorders Other: Family Navigator consultation Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.

Other: Family Navigator consultation

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 Name: Patient navigator services

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.

Primary Outcome Measures :
  1. Family Empowerment Scale [ Time Frame: Change from baseline to 90 days ]
    This 34-item, scale provides scores for parent empowerment related to their Family (e.g. "I make efforts to help my child grow and develop."), Services System ("My opinion is just as important as professionals who are providing services to my child."), and Community ("I feel I can have a part in improving services for children in my community."). The subscales have demonstrated good reliability and validity, and provide comprehensive information about empowerment, including attitudes, knowledge, and behaviors.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. Child Behavior Checklist [ 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, and well as two broadband scores, Externalizing (behavioral) and Internalizing (mood) problems. These measures have been widely used in pediatric mental health research.

  2. Psychosocial Service Utilization [ Time Frame: Change from Baseline to 90 days ]
    We will utilize 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 90 days (the initial medication authorization period). We will also collect parent report data on any other, non-Medicaid reimbursed psychosocial services utilized during those time periods (e.g. school services, parent mental health treatment, peer support groups).

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Child 12 years old and younger who has been approved by the maryland medicaid program for treatment with an antipsychotic medication.

Exclusion Criteria:

Department of social services custody

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01804582

United States, Maryland
University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Gloria M Reeves, M.D. University of Maryland

Responsible Party: Gloria Reeves, M.D. , Associate Professor, University of Maryland Identifier: NCT01804582     History of Changes
Other Study ID Numbers: HP-00054913
1300476 ( Other Identifier: Patient Centered Outcome Research Institute (PCORI) )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Keywords provided by Gloria Reeves, University of Maryland:
Family navigator
Patient Centered Outcomes
Pediatric Antipsychotic treatment

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs