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Behavioural Intervention
Family Spirit Programs for Mental Health Issues (FSS Trial)
N/A
Recruiting
Led By Emily Haroz
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-6 months post baseline, 6-8 months post baseline
Awards & highlights
FSS Trial Summary
This trial will test an evidence-based program to help American Indian/Alaska Native communities address mental/behavioral health issues. It combines skills-based approaches with cultural elements to build self-efficacy and connections.
Who is the study for?
This trial is for self-identifying females who are pregnant or primary caregivers of a child under 24 months, aged 14+, with family history of substance use and symptoms/risk of depression, anxiety, or substance use disorder. Participants must be from certain service populations.Check my eligibility
What is being tested?
The study tests the Family Spirit Strengths (FSS) program against an evidence-based nutrition education program in a randomized controlled trial to improve mental health and coping skills among American Indian/Alaska Native communities.See study design
What are the potential side effects?
Since FSS is a non-medical intervention focusing on skill-building and education, typical medical side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues.
FSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-6 months post baseline, 6-8 months post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-6 months post baseline, 6-8 months post baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in number of poor mental health days in last 30 days as assessed by a single item on the Health-Related Quality of Life (HRQOL) measure
Secondary outcome measures
Change in Substance Use as measure by the Timeline Follow Back for Substance Use
Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
FSS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Family Spirit Strengths (FSS)Experimental Treatment1 Intervention
FSS participants will receive 4-16 (average of 6-8) intervention visits covering topics related to their mental and behavioral health. The number of sessions each participant receives varies and depends on their unique needs. To guide this process, all intervention participants will take a brief, in-session survey to screen for current challenges they may be facing. Their answers will help determine the content and dose of future sessions.
Group II: Family Spirit NurtureActive Control1 Intervention
Participants enrolled in nutrition education comparison group will receive 6 educational lessons related to promoting early childhood healthy growth. Lessons will be delivered bi-weekly for no longer than 4-months total. The lessons are from the evidence-based Family Spirit Nurture curriculum.
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Who is running the clinical trial?
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,106,742 Total Patients Enrolled
19 Trials studying Depression
8,214 Patients Enrolled for Depression
Emily HarozPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 14 years old or older.I have a severe disability that prevents me from participating in assessments or treatments.I am experiencing high levels of depression, anxiety, or at risk for substance abuse.I identify as female.
Research Study Groups:
This trial has the following groups:- Group 1: Family Spirit Strengths (FSS)
- Group 2: Family Spirit Nurture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies in this experiment for volunteers?
"Clinicaltrials.gov reports that this medical trial, which began on May 1st 2023, is not currently looking to enrol candidates at this moment in time. Fortunately for those interested in participating, there are 1892 other clinical studies actively recruiting patients."
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