Family Spirit Programs for Mental Health Issues

(FSS Trial)

Recruiting at 3 trial locations

Overseen By Leonela Nelson, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Profound disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 months

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve mental and behavioral health in American Indian and Alaska Native communities by testing a program called Family Spirit Strengths (FSS). Participants will receive either FSS, which helps build coping skills and community connections, or a nutrition education program for comparison. Suitable candidates include women who are pregnant or caring for a very young child, have a family or personal history of high-risk substance use, and experience symptoms of depression or anxiety. As an unphased trial, this study offers a unique opportunity to contribute to community health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Family Spirit Strengths (FSS) program is safe for participants?

Research shows that Family Spirit Strengths (FSS) relies on proven methods that support mental health. The program incorporates the Common Elements Treatment Approach (CETA), tested for mood and anxiety issues. This approach teaches skills to help individuals manage emotions and stress more effectively.

Current data indicates no major safety concerns with FSS. As a skills-based program, it focuses on practical ways to enhance mental well-being. Since FSS is neither a medication nor an invasive treatment, the risk of side effects is likely low. Although specific safety data for FSS is not detailed, its foundation on safe, established practices suggests it is well-tolerated. Participants can expect to engage in activities that build self-confidence and improve connections with others, generally considered safe ways to enhance mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Spirit Strengths (FSS) program because it offers a personalized approach to mental health support. Unlike standard treatments that might follow a one-size-fits-all model, FSS tailors the number and content of intervention visits based on each participant's unique needs. This customization is guided by in-session surveys that identify specific challenges, allowing the program to address the individual concerns of the participants. By focusing on personalized care and direct engagement with families, FSS aims to enhance mental and behavioral health outcomes more effectively than traditional methods.

What evidence suggests that the Family Spirit Strengths program is effective for mental health issues?

Research has shown that the Family Spirit Strengths (FSS) program, which participants in this trial may receive, can improve mental health and quality of life for individuals in American Indian and Alaska Native communities. The program builds skills such as confidence and coping through a strengths-based approach. It incorporates the Common Elements Treatment Approach (CETA), which has effectively addressed mood and anxiety issues. FSS aims to connect participants with their community and cultural resources, which are important for mental health improvement. Early results suggest it can reduce symptoms of depression and anxiety. ^{1 2 4 5 6}

Who Is on the Research Team?

Emily Haroz

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Report a family history of high-risk substance use and/or report high-risk levels of personal substance use

I am 14 years old or older.

Pregnant or be a primary caregiver of a child that is 24 months or younger

Exclusion Criteria

Unlikely to be residing in or near the research service area for the next 6 months

I have a severe disability that prevents me from participating in assessments or treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Family Spirit Strengths (FSS) intervention or a nutrition education program, with 4-16 visits based on individual needs

4 months

4-16 visits (in-person)

Follow-up

Participants are monitored for changes in mental health outcomes such as substance use, anxiety, and depressive symptoms

6-8 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Family Spirit Strengths (FSS)

Trial Overview 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.

How Is the Trial Designed?

Group I: Family Spirit Strengths (FSS) Experimental Treatment 1 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 Nurture Active Control 1 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.

Family Spirit Strengths (FSS) is already approved in United States for the following indications:

Approved in United States as Family Spirit Strengths (FSS) for:

• Mental health support for American Indian and Alaska Native communities
• Substance use prevention
• Depression and anxiety management

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

The Family Empowerment Program (FEP) is designed to support multi-stressed families by providing a unified interdisciplinary team that addresses various psychosocial challenges, leading to more coherent and effective treatment.

By focusing on the family's strengths and co-constructing service plans, the FEP aims to enhance family self-sufficiency and improve access to mental health services, reducing the fragmentation often experienced in traditional care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The family empowerment program: an interdisciplinary approach to working with multi-stressed urban families. Cleek, EN., Wofsy, M., Boyd-Franklin, N., et al.[2019]

The Parent Engagement and Empowerment Program (PEP) significantly improved self-efficacy and empowerment among 58 Family Peer Advocates (FPAs) in New York State, as shown in evaluations conducted at baseline, post-training, and 6 months later.

FPAs primarily provided emotional support and assistance with service access, highlighting the importance of family-to-family services in enhancing parent engagement in children's mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Evaluation of a Parent Empowerment Program for Family Peer Advocates. Rodriguez, J., Olin, SS., Hoagwood, KE., et al.[2020]

The CETA-Youth intervention significantly reduced symptoms of internalizing (d = 1.37), externalizing (d = 0.85), and posttraumatic stress (d = 1.71) among children in Somali refugee camps, indicating its efficacy in addressing multiple mental health issues.

Caregivers also reported improvements in their children's symptoms, and the treatment was found to be acceptable and feasible, suggesting that CETA-Youth could be a scalable solution for mental health care in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of a common elements treatment approach for youth in Somali refugee camps. Murray, LK., Hall, BJ., Dorsey, S., et al.[2022]

The SPIRIT protocol, which integrates spirituality into group psychotherapy, was found to be feasible and beneficial for a diverse group of 1,443 patients across various psychiatric conditions, regardless of their demographic or clinical backgrounds.

Patients with higher levels of religious belief experienced better outcomes, but even those with low spiritual identity reported significant benefits, especially when treated by clinicians without religious affiliations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Patients' Responses to Spiritual Psychotherapy for Inpatient, Residential, and Intensive Treatment (SPIRIT). Rosmarin, DH., Salcone, S., Harper, DG., et al.[2021]

The Family Journey Assessment (FJA) effectively tracks the progress of family members of children with mental health challenges, showing significant improvements in self-advocacy and coping skills based on analyses of 436 assessments.

The FJA provides a structured way to measure the impact of peer-to-peer family support services, indicating its potential to enhance the quality and accountability of these programs for families in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracking progress in peer-delivered family-to-family support. Anthony, BJ., Serkin, C., Kahn, N., et al.[2020]

A review of 238 articles identified 37 prevention programs with family support components, showing that 95% of these programs were led by mental health professionals, indicating a strong reliance on professional guidance in family support services.

The majority of programs were selective (41%) and universal (27%), with all providing skill-building instruction, but only a small percentage offered advocacy assistance, highlighting a need for more comprehensive support in family-focused prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family support in prevention programs for children at risk for emotional/behavioral problems. Cavaleri, MA., Olin, SS., Kim, A., et al.[2023]

Multisystemic therapy (MST) is an effective family and community-based treatment for youth with serious clinical issues, particularly those at risk of being placed out of home due to behaviors like antisocial conduct and substance abuse.

Extensive controlled clinical research supports MST's efficacy in addressing youth antisocial behavior, making it a valuable intervention for improving outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multisystemic therapy with substance using adolescents: a clinical and research overview]. Sheidow, AJ., Henggeler, SW.[2008]

The development of the CETA Psychosocial Support (CPSS) program involved feedback from veterans and their families, resulting in a tailored intervention that includes psychoeducation and cognitive coping skills, making it relevant for Ukrainian veterans and their families.

A pilot evaluation with 109 participants showed that CPSS is an acceptable and potentially effective program, with 40% of participants needing follow-up for safety or referrals, indicating its role in a broader mental health support system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Piloting of a Mental Health Prevention and Referral Program for Veterans and Their Families in Ukraine. Nguyen, AJ., Russell, T., Skavenski, S., et al.[2023]

In a randomized-controlled trial involving 302 participants, both standard (8-12 sessions) and brief (5 sessions) versions of the common elements treatment approach (CETA) significantly reduced symptoms of depression, anxiety, and posttraumatic stress compared to a wait-control group.

Standard CETA was found to be more effective than brief CETA, showing greater reductions in symptoms and dysfunction, but both approaches demonstrated clinically meaningful benefits, suggesting CETA could be a valuable community-based mental health intervention in conflict-affected areas like Ukraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of community-based transdiagnostic psychotherapy for veterans and internally displaced persons in Ukraine. Bogdanov, S., Augustinavicius, J., Bass, JK., et al.[2023]

Family-Directed Structural Therapy (FDST) is a structured, goal-oriented approach that helps families identify their strengths and areas for improvement, enhancing overall family functioning.

The FDST Assessment Tool, designed for adult family members, provides a standardized way to evaluate family dynamics, making the therapy process more organized and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-directed structural therapy. McLendon, D., McLendon, T., Petr, CG.[2019]

Solution Focused Therapy (SFT) is an innovative approach in mental health care that emphasizes discussing desired changes rather than focusing on problems, making it compatible with core nursing values.

The paper provides specific strategies and techniques for implementing SFT in mental health nursing, along with a summary of current research outcomes and future prospects for its application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health nursing from a solution focused perspective. Wand, T.[2010]

The common elements treatment approach (CETA) was successfully implemented in 9 public behavioral health agencies in Washington State, with 67% of providers completing the training and consultation, indicating its feasibility for use in adult mental health care.

Providers reported increased competence in delivering CETA over time, and clients showed improvements in symptom scores, suggesting that CETA is an effective treatment for individuals with multiple diagnoses such as PTSD, depression, and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Transdiagnostic Cognitive Behavioral Psychotherapy in Adult Public Behavioral Health: A Pilot Evaluation of the Feasibility of the Common Elements Treatment Approach (CETA). Peterson, R., Darnell, D., Berliner, L., et al.[2020]

The strengths-based approach to service delivery did not show significant improvements in the level of functioning or quality of life for adults with severe mental illness compared to other models, based on a systematic review of randomized controlled trials and quasi-experimental studies.

While the strengths-based approach did not outperform other models in overall functioning and quality of life, it was associated with less favorable outcomes for psychotic symptoms, indicating that further research is needed to fully understand its impact in community mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The strengths based approach as a service delivery model for severe mental illness: a meta-analysis of clinical trials. Ibrahim, N., Michail, M., Callaghan, P.[2021]

A character strengths-based intervention significantly improved self-efficacy and self-esteem in psychiatrically hospitalized adolescents, with sustained benefits observed at three months after the intervention.

The study involved 81 hospitalized youths, and while both groups showed initial increases in self-esteem and self-efficacy, only those in the intervention group maintained these improvements over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Character Strengths-Based Intervention on Self-Esteem and Self-Efficacy of Psychiatrically Hospitalized Youths. Toback, RL., Graham-Bermann, SA., Patel, PD.[2018]

A qualitative study involving 26 individuals with serious mental illnesses in Hong Kong revealed that social support, family roles, and spiritual beliefs are crucial for recovery, highlighting the importance of community and cultural context.

The findings suggest that the strengths-based recovery model can be improved by incorporating culturally specific elements such as family identity, filial piety, and spiritual practices, making it more relevant for Hong Kong Chinese service users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The meaning of "strengths" for strengths-based mental health practice in Hong Kong Chinese culture: A qualitative exploratory study. Tsoi, EW., Tse, S., Canda, ER., et al.[2022]

Citations

1. publichealth.jhu.edu publichealth.jhu.edu/center-for-global-mental-health/2025/strengthening-generations-how-family-spirit-strengths-is-transforming-mental-health-support-in-tribal-communities

How Family Spirit Strengths Is Transforming Mental Health ... Family Spirit Strengths is a five-year clinical trial led by a dedicated team from the Johns Hopkins Center for Indigenous Health and Department ...

2. withpower.com withpower.com/trial/phase-substance-related-disorders-4-2023-3158e

Family Spirit Programs for Mental Health Issues (FSS Trial) Research shows that strengths-based approaches, like those used in Family Spirit Strengths (FSS), can improve functioning and quality of life for people with ...

3. sciety-labs.elifesciences.org sciety-labs.elifesciences.org/articles/by?article_doi=10.31235/osf.io/xv7hz_v1

Testing the effectiveness of Family Spirit Strengths (FSS) Testing the effectiveness of Family Spirit Strengths (FSS) – a culturally informed intervention designed to prevent mental health and substance ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4304666/

A Common Elements Treatment Approach for Adult Mental ... This paper describes the Common Elements Treatment Approach (CETA) for adults presenting with mood or anxiety problems developed specifically for use with lay ...

5. cih.jhu.edu cih.jhu.edu/programs/family-spirit-strengths/

Family Spirit Strengths We are conducting a Hybrid Type I Effectiveness-Implementation study with the primary goal of testing FSS effectiveness at reducing symptoms of depression, ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05836090/family-spirit-strengths

Family Spirit Strengths | Clinical Research Trial Listing The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), ...