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NCT01804582 · ClinicalTrials.gov registry record · NA

The Family VOICE Study

A NA study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
NA
Development phase
350
Enrollment target

NCT01804582: Completed NA study, sponsored by University of Maryland, Baltimore.

NCT01804582 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 350 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01804582, a NA study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
NA
Development phase
350 participants
Enrollment target

Study 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 pare

Primary Outcome

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

Interventions

  • OTHER Family Navigator consultation

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2013-05
Est. Completion 2016-03-31
Phase NA
University of Maryland, Baltimore

560 total trials

What the finished NCT01804582 record still lists

NCT01804582 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Family Navigator consultation is the first listed.

NCT01804582 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01804582 about?

NCT01804582 is a clinical study titled "The Family VOICE Study". 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...

What is the current status of trial NCT01804582?

This trial is currently completed. It is a NA study. The enrollment target is 350 participants. The study started on 2013-05. Estimated completion is 2016-03-31.

What interventions are being tested in trial NCT01804582?

The interventions under investigation include: Family Navigator consultation (OTHER).

Who is sponsoring clinical trial NCT01804582?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01804582's enrollment target sits among peer trials

350 292nd of 2000 higher than 1,699 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01804582, the US trial registry maintained by the National Library of Medicine. NCT01804582 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.