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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01804582
Enrollment
350
Registered
2013-03-05
Start date
2013-05-31
Completion date
2016-03-31
Last updated
2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression, Autism, Bipolar Disorder, Psychotic Disorders

Keywords

Family navigator, Patient Centered Outcomes, Pediatric Antipsychotic treatment

Brief 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.

Interventions

OTHERFamily 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.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Family Empowerment ScaleChange from baseline to 90 daysThis 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.
Duke-UNC (University of North Carolina) Functional Social Support QuestionnaireChange from Baseline to 90 daysThis 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.
Youth Services Survey for FamiliesChange from Baseline to 90 daysThis 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.

Secondary

MeasureTime frameDescription
Child Behavior Checklist - Brief Problem MonitorChange from Baseline to 90 daysWe 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.
Psychosocial Service UtilizationChange from Baseline to 90 daysWe 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.
Medication RegimenChange from Baseline to 90 daysWe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Family Navigator Consultation
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, (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.
175
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.
173
Total348

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up4756
Overall StudyPhysician Decision20

Baseline characteristics

CharacteristicUsual CareFamily Navigator ConsultationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants5 Participants10 Participants
Age, Categorical
Between 18 and 65 years
168 Participants170 Participants338 Participants
Age, Continuous38.47 years
STANDARD_DEVIATION 10
40.09 years
STANDARD_DEVIATION 10.06
39.28 years
STANDARD_DEVIATION 10.05
Region of Enrollment
United States
173 participants175 participants348 participants
Sex: Female, Male
Female
158 Participants167 Participants325 Participants
Sex: Female, Male
Male
15 Participants8 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 1770 / 173
serious
Total, serious adverse events
0 / 1770 / 173

Outcome results

Primary

Duke-UNC (University of North Carolina) Functional Social Support Questionnaire

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.

Time frame: Change from Baseline to 90 days

Population: An intent to treat analysis was conducted with a linear mixed model on all outcome data collected at baseline and 3 months to determine significance of change.

ArmMeasureGroupValue (MEAN)Dispersion
Family Navigator ConsultationDuke-UNC (University of North Carolina) Functional Social Support QuestionnaireBaseline Outcome2.58 units on a scaleStandard Deviation 1.1
Family Navigator ConsultationDuke-UNC (University of North Carolina) Functional Social Support Questionnaire3 month Outcome2.48 units on a scaleStandard Deviation 1.1
Usual CareDuke-UNC (University of North Carolina) Functional Social Support QuestionnaireBaseline Outcome2.46 units on a scaleStandard Deviation 1.07
Usual CareDuke-UNC (University of North Carolina) Functional Social Support Questionnaire3 month Outcome2.45 units on a scaleStandard Deviation 1.06
p-value: 0.53Mixed Models Analysis
Primary

Family Empowerment Scale

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.

Time frame: Change from baseline to 90 days

Population: An intent to treat analysis was conducted with a linear mixed model which included data from all participants collected at baseline and 3 months.

ArmMeasureGroupValue (MEAN)Dispersion
Family Navigator ConsultationFamily Empowerment Scalebaseline outcome3.75 units on a scaleStandard Deviation 0.52
Family Navigator ConsultationFamily Empowerment Scale3 month outcome3.81 units on a scaleStandard Deviation 0.55
Usual CareFamily Empowerment Scale3 month outcome4.02 units on a scaleStandard Deviation 0.51
Usual CareFamily Empowerment Scalebaseline outcome3.86 units on a scaleStandard Deviation 0.51
Comparison: An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.p-value: 0.15Mixed Models Analysis
Primary

Youth Services Survey for Families

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.

Time frame: Change from Baseline to 90 days

Population: An intent to treat analysis was conducted with a linear mixed model on all data collected at baseline and 3 months.

ArmMeasureGroupValue (MEAN)Dispersion
Family Navigator ConsultationYouth Services Survey for FamiliesBaseline Outcome3.75 units on a scaleStandard Deviation 0.64
Family Navigator ConsultationYouth Services Survey for Families3 month Outcome3.81 units on a scaleStandard Deviation 0.61
Usual CareYouth Services Survey for FamiliesBaseline Outcome3.90 units on a scaleStandard Deviation 0.63
Usual CareYouth Services Survey for Families3 month Outcome3.95 units on a scaleStandard Deviation 0.6
p-value: 0.8Mixed Models Analysis
Secondary

Child Behavior Checklist - Brief Problem Monitor

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.

Time frame: Change from Baseline to 90 days

Population: An intent to treat analysis was conducted with a linear mixed model on all data collected at baseline and 3 months.

ArmMeasureGroupValue (MEAN)Dispersion
Family Navigator ConsultationChild Behavior Checklist - Brief Problem MonitorBaseline Outcome69.51 units on a scaleStandard Deviation 5.69
Family Navigator ConsultationChild Behavior Checklist - Brief Problem Monitor3 month Outcome67.63 units on a scaleStandard Deviation 6.03
Usual CareChild Behavior Checklist - Brief Problem MonitorBaseline Outcome69.19 units on a scaleStandard Deviation 5.62
Usual CareChild Behavior Checklist - Brief Problem Monitor3 month Outcome66.73 units on a scaleStandard Deviation 6.83
p-value: 0.33Mixed Models Analysis
Secondary

Medication Regimen

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.

Time frame: Change from Baseline to 90 days

Population: The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Family Navigator ConsultationMedication RegimenDose increase over 90 days26 Participants
Family Navigator ConsultationMedication RegimenNo dose increase over 90 days84 Participants
Usual CareMedication RegimenDose increase over 90 days49 Participants
Usual CareMedication RegimenNo dose increase over 90 days70 Participants
Comparison: The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)p-value: 0.005Chi-squared
Secondary

Psychosocial Service Utilization

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.

Time frame: Change from Baseline to 90 days

Population: The same participants 175 FN and 173 TAU participants were analyzed for psychosocial claims during the 90 day period prior to enrollment and then 90 days during enrollment. The count of participants represents the number of subjects (from the 175 FN and 173 TAU) that had at least 1 claim during each specified time period.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Family Navigator ConsultationPsychosocial Service UtilizationPS claim 90 days prior to enrollment with services120 Participants
Family Navigator ConsultationPsychosocial Service Utilization90 days during enrollment112 Participants
Family Navigator ConsultationPsychosocial Service UtilizationNo PS claim 90 day prior to enrollment35 Participants
Family Navigator ConsultationPsychosocial Service UtilizationNo PS claim 90 days during enrollment63 Participants
Usual CarePsychosocial Service UtilizationNo PS claim 90 days during enrollment65 Participants
Usual CarePsychosocial Service UtilizationPS claim 90 days prior to enrollment with services108 Participants
Usual CarePsychosocial Service UtilizationNo PS claim 90 day prior to enrollment65 Participants
Usual CarePsychosocial Service Utilization90 days during enrollment108 Participants
p-value: 0.21Wald Chi-Squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026