Trial Outcomes & Findings for The Family VOICE Study (NCT NCT01804582)

NCT ID: NCT01804582

Last Updated: 2019-11-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 350 participants
• Primary outcome timeframe: Change from baseline to 90 days
• Results posted on: 2019-11-20

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	177	173
Overall Study COMPLETED	128	117
Overall Study NOT COMPLETED	49	56

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	47	56
Overall Study Physician Decision	2	0

Baseline Characteristics

The Family VOICE Study

Baseline characteristics by cohort

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.	Total n=348 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	170 Participants n=5 Participants	168 Participants n=7 Participants	338 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	40.09 years STANDARD_DEVIATION 10.06 • n=5 Participants	38.47 years STANDARD_DEVIATION 10.00 • n=7 Participants	39.28 years STANDARD_DEVIATION 10.05 • n=5 Participants
Sex: Female, Male Female	167 Participants n=5 Participants	158 Participants n=7 Participants	325 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	175 participants n=5 Participants	173 participants n=7 Participants	348 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.
Family Empowerment Scale baseline outcome	3.75 units on a scale Standard Deviation .52	3.86 units on a scale Standard Deviation .51
Family Empowerment Scale 3 month outcome	3.81 units on a scale Standard Deviation .55	4.02 units on a scale Standard Deviation .51

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.
Duke-UNC (University of North Carolina) Functional Social Support Questionnaire 3 month Outcome	2.48 units on a scale Standard Deviation 1.10	2.45 units on a scale Standard Deviation 1.06
Duke-UNC (University of North Carolina) Functional Social Support Questionnaire Baseline Outcome	2.58 units on a scale Standard Deviation 1.10	2.46 units on a scale Standard Deviation 1.07

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.
Youth Services Survey for Families Baseline Outcome	3.75 units on a scale Standard Deviation .64	3.90 units on a scale Standard Deviation .63
Youth Services Survey for Families 3 month Outcome	3.81 units on a scale Standard Deviation .61	3.95 units on a scale Standard Deviation .60

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.
Child Behavior Checklist - Brief Problem Monitor Baseline Outcome	69.51 units on a scale Standard Deviation 5.69	69.19 units on a scale Standard Deviation 5.62
Child Behavior Checklist - Brief Problem Monitor 3 month Outcome	67.63 units on a scale Standard Deviation 6.03	66.73 units on a scale Standard Deviation 6.83

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Family Navigator Consultation n=175 Participants 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.	Usual Care n=173 Participants 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.
Psychosocial Service Utilization No PS claim 90 days during enrollment	63 Participants	65 Participants
Psychosocial Service Utilization PS claim 90 days prior to enrollment with services	120 Participants	108 Participants
Psychosocial Service Utilization 90 days during enrollment	112 Participants	108 Participants
Psychosocial Service Utilization No PS claim 90 day prior to enrollment	35 Participants	65 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Family Navigator Consultation n=110 Participants 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.	Usual Care n=119 Participants 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.
Medication Regimen Dose increase over 90 days	26 Participants	49 Participants
Medication Regimen No dose increase over 90 days	84 Participants	70 Participants

Adverse Events

Family Navigator Consultation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Family Navigator Consultation n=177 participants at risk 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.	Usual Care n=173 participants at risk 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.
Psychiatric disorders Suspected Child Abuse/Neglect	1.7% 3/177 • Number of events 3 • Safety monitoring for adverse events was conducted throughout the study for each participant at baseline, each family navigator contact and 3 months. Over the course of the study 3 cases of suspected abuse was reported to the Department of Social Services Child Protective Services.	0.00% 0/173 • Safety monitoring for adverse events was conducted throughout the study for each participant at baseline, each family navigator contact and 3 months. Over the course of the study 3 cases of suspected abuse was reported to the Department of Social Services Child Protective Services.

Additional Information

Gloria M. Reeves, M.D.

University of Maryland, Baltimore

Phone: 410-328-3522

Email: greeves@psych.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place