Results Summary

What was the research about?

Parents whose children need mental health services often feel overwhelmed. Having support from others with similar experiences may help parents manage their families’ needs.

In this study, the research team wanted to learn if family navigators helped parents of children who need mental health services. The family navigators were parents who had raised a child who needed mental health services. They were available by phone to offer emotional support and help parents manage care for their children. Family navigators also helped parents find resources for treatment and daily living. The research team compared two groups: parents who had family navigators and parents who received usual mental health care.

What were the results?

After 90 days, the research team found no differences between the two groups in

  • Parents’ feelings of involvement and control in their children’s mental health care
  • Parents’ feelings of social support
  • Parents’ satisfaction with their children’s mental health care
  • Children’s behavior
  • Amount of therapy that children received

Children whose parents had family navigators were less likely to increase doses of medicines for mental illness than children whose parents received usual care.

Many parents who had family navigators asked for help with daily living needs. They most often requested help with housing or getting food.

Who was in the study?

The study included 348 parents with low incomes in Maryland. Each child was 16 years old or younger. Children had Medicaid and were approved to take medicine for mental illness. In this study, 93 percent of parents were female, 56 percent were white, and 34 percent were African American.

What did the research team do?

The research team assigned parents to one of two groups by chance. One group of parents received one-on-one phone support from family navigators. Parents chose how often and how long they spoke with their family navigator. Family navigators offered parents emotional support. They also told parents about therapy services or other resources when parents asked for help. The second group of parents continued their children’s usual medical care. At the end of the study, the research team offered the second group of parents information on parent-support programs.

The research team asked parents in both groups to rate

  • Their feelings of involvement and control in their child’s mental health care
  • Their feelings of social support
  • Their satisfaction with their child’s mental health care
  • Their child’s behavior

The research team compared the ratings from the groups at the start of the study and after 90 days. The team also looked at how often children went to therapy and whether the medicine they took changed. An advisory group helped guide the study. The group included parents, mental health doctors, and child service workers.

What were the limits of the study?

The study was only 90 days long. This time period may not have been long enough to cause major changes in parents’ responses. The team didn’t contact children or children’s doctors directly. Doing so may have helped the team see changes that weren’t reported by parents.

Many parents in the study asked for help with daily living needs. Future research could look for ways to help families with these types of concerns.

How can people use the results?

Clinics that provide care for children who take medicine for mental illness may consider using programs like the one in the study to support the children and their families. Staff from these programs should consider whether parents need help with daily needs like food and housing.

Final Research Report

View this project's final research report.

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Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Clarifying the role that patients and other stakeholders played in the development of study aims and other processes before and during study implementation
  • Providing more details in the Methods to address reviewer concerns that the report lacked several reporting elements required by the CONSORT statement. This included describing modifications to the study eligibility criteria and sample size
  • Clarifying and describing their assumptions regarding missing data, and describing sensitivity analyses performed to determine whether results differed when including data from families who did not complete the study, or who did not use the Family Navigator intervention. The result was no change in the outcomes of the study, indicating that the intervention did not have a significant effect on most primary and secondary outcomes even when limiting the analysis to families who completed treatment
  • Revising the Results and Discussion sections of the report and the abstract to clearly state the primary and secondary outcomes, and acknowledge null findings. These were separated from the more positive post-hoc analyses

Conflict of Interest Disclosures

Project Information

Gloria Reeves, MD
University of Maryland Baltimore
$1,452,517
10.25302/3.2019.CER.997
The Family VOICE Study: A Randomized Trial of Family Navigator Services Versus Usual Care for Young Children Treated with Antipsychotic Medication

Key Dates

December 2012
May 2018
2012
2018

Study Registration Information

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Last updated: January 20, 2023