The Family VOICE Study
Condition: Autism; Aggression; Bipolar Disorder; Psychotic Disorders
MeSH terms: Bipolar Disorder; Psychotic Disorders; Aggression
Study type: Interventional

Summary: 
      Family centered mental health treatment with children values and supports the role of parents
      in their child's recovery. However, medications are often the primary focus in community
      treatment, even in preschool age youth, with increasing use of antipsychotic medication for
      serious mood and behavior problems. Although medication may be necessary to address safety
      issues (such as severe aggression) it can cause serious side effects, such as obesity, and
      medication only does not follow recommended care for these types of problems. Psychosocial
      treatments are highly recommended (e.g. Programs that coach empower parents to manage their
      child's difficult behaviors) as part of comprehensive 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 (e.g. long waiting lists) and use (e.g. parent mistrust 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 reduces unnecessary medication treatment and ensures children
      have adequate health screening before starting any treatment. Those approved for medication
      have moderate-severe mental health problems, which supports their need for comprehensive
      (medication and psychosocial) treatment, instead of medication only. In this study,
      investigators partner with parents/family advocates, child-serving agencies, and health
      providers to develop a Family Navigator (FN) Service to link with this medication program. A
      FN is an individual who has cared for their own child with mental illness. The FN supports
      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 FN Service will improve the child's overall
      mental health and reduce the likelihood of a medication dose increase or another medication
      added during the initial treatment period. The FN Service is provided for parents of public
      insured children ages 3-15 years newly approved for antipsychotic medication treatment. The
      FN Services will be provided by phone, which supports families in both rural and urban
      settings. The investigators' long term goal is to develop a FN program that strongly supports
      Family-centered treatment of children and can be used to help families in other underserved
      areas beyond Maryland.
    

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.
    

Intervention name(s): Family Navigator consultation
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Patient navigator services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Family navigator; Patient Centered Outcomes; Pediatric Antipsychotic treatment