What side effects are associated with this type of intervention?

Common treatments for mental health conditions include pharmacotherapy, psychotherapy, and combined approaches. Pharmacotherapy, such as antidepressants and antipsychotics, can cause side effects like weight gain, drowsiness, dry mouth, and gastrointestinal issues. Psychotherapy, including cognitive-behavioral therapy (CBT) and interpersonal therapy (IPT), generally has fewer physical side effects but may cause emotional discomfort as patients confront difficult issues. Combined treatments can offer enhanced benefits but also carry the risk of combined side effects from both medication and therapy. Family support and mobile health technologies, as studied in the FMHN project, aim to improve engagement and adherence to these treatments, potentially mitigating some side effects by providing better support and monitoring.

What prior FDA approvals exist?

The Family Mental Health Navigator (FMHN) trial aims to enhance mental health service engagement through family support and mobile health technologies. While specific FDA approvals for such integrative approaches are limited, several drugs have been approved for mental health conditions. These include antidepressants like fluoxetine and sertraline, antipsychotics like olanzapine, and stimulants like methylphenidate for ADHD. Additionally, digital health technologies and telehealth platforms have gained traction, although they may not be FDA-approved as treatments, they are increasingly used to support mental health care delivery.

What other types of research exist?

Promising alternatives to the Family Mental Health Navigator (FMHN) for mental health patients include: 1) Telemedicine platforms that offer remote therapy and psychiatric consultations, improving access to care. 2) Mobile apps designed for mental health management, such as those providing cognitive-behavioral therapy (CBT) exercises, mood tracking, and real-time support. 3) Digital peer support networks that connect patients with trained peer counselors for emotional and practical support. 4) Integrated care models that combine primary care and mental health services, ensuring comprehensive and coordinated treatment. 5) Virtual reality (VR) therapy for conditions like PTSD and anxiety, offering immersive and controlled therapeutic environments.

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Mental Health Navigation for Youth Mental Health (FMHN Trial)

N/A

Recruiting

Led By Marina Tolou-Shams, Ph.D

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 6-17

Be younger than 18 years old

Must not have

Youth is not English-speaking nor Spanish-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a support system called the Family Mental Health Navigator (FMHN) combined with mobile technology to help publicly-insured youth access mental health services. It aims to improve how these young people start and stay in treatment, especially those from racial and ethnic minority groups.

Who is the study for?

This trial is for English or Spanish-speaking children aged 6-17 who are publicly insured and currently receiving services at San Francisco General Hospital. They must have mobile phone access and an involved caregiver to provide consent. Children without a guardian's consent, non-English/Spanish speakers, or caregivers unable to give informed consent cannot participate.

What is being tested?

The study is testing a new approach called the Family Mental Health Navigator (FMHN), which uses family-based guidance along with mobile health technology to see if it helps young people start and stick with mental health services more effectively.

What are the potential side effects?

Since this intervention involves counseling and support rather than medication, there may not be physical side effects. However, participants might experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to treatment initiation

Time to treatment referral

Treatment engagement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Family-based mental health navigationExperimental Treatment1 Intervention

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mental health issues include psychotherapy, pharmacotherapy, and integrative approaches like family support and mobile health technologies. Psychotherapy, such as cognitive-behavioral therapy (CBT), works by helping patients identify and change negative thought patterns and behaviors. Pharmacotherapy involves medications that alter brain chemistry to improve mood and cognitive function. The FMHN trial focuses on family support and mobile health technologies, which facilitate access to and engagement with mental health services. These approaches work by providing continuous support, improving adherence to treatment plans, and enhancing communication between patients and healthcare providers. Understanding these mechanisms is crucial for mental health patients as it empowers them to actively participate in their treatment, leading to better outcomes and improved quality of life.

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