The Family VOICE Study

Status:Enrolling by invitation
Conditions:Neurology, Psychiatric, Bipolar Disorder, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Age Range:1 - 12
Start Date:May 2013
End Date:May 2017

Use our guide to learn which trials are right for you!

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 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.

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.

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
We found this trial at
Baltimore, MD
Click here to add this to my saved trials