Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01804582
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2013-02-27
Brief Title:
The Family VOICE Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Family centered mental health treatment with children values and supports the role of parents in their childs 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 eg Programs that coach empower parents to manage their childs difficult behaviors as part of comprehensive child treatment Parent involvement in psychosocial treatment has clear benefits for their childs mental health and unlike medication the effects can last long after treatment is completed However problems related to access eg long waiting lists and use eg 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 parentsfamily 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 childs mental health treatment The investigators also expect that the FN Service will improve the childs 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 eg new onset diabeteshas heightened concerns about sharp increases in off label pediatric antipsychotic treatment of moodbehavioral 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 childs mental health recovery Psychosocial treatments eg 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1300476 | OTHER | Patient Centered Outcome Research Institute PCORI | None |