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

Trial Summary

What is the purpose of this trial?

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

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 data supports the effectiveness of the Family Spirit Strengths (FSS) treatment for mental health issues?

Research shows that strengths-based approaches, like those used in Family Spirit Strengths (FSS), can improve functioning and quality of life for people with severe mental illness. Additionally, focusing on character strengths has been found to boost self-esteem and self-efficacy in young people with mental health challenges. ^{1 2 3 4 5}

Is the Family Spirit Programs treatment safe for humans?

The Common Elements Treatment Approach (CETA), which is related to Family Spirit Programs, has been tested in various settings, including with veterans and refugees, and no safety concerns have been reported in these studies. ^{6 7 8 9 10}

How is the Family Spirit Strengths (FSS) treatment different from other treatments for mental health issues?

Family Spirit Strengths (FSS) is unique because it focuses on empowering families by emphasizing their strengths and competencies, and it involves a unified team approach to address multiple psychosocial challenges. This contrasts with traditional treatments that may not integrate family strengths or provide coordinated support across different systems. ^{11 12 13 14 15}

Research Team

Emily Haroz

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Family-directed structural therapy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The strengths based approach as a service delivery model for severe mental illness: a meta-analysis of clinical trials. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Character Strengths-Based Intervention on Self-Esteem and Self-Efficacy of Psychiatrically Hospitalized Youths. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The meaning of "strengths" for strengths-based mental health practice in Hong Kong Chinese culture: A qualitative exploratory study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development and Piloting of a Mental Health Prevention and Referral Program for Veterans and Their Families in Ukraine. [2023]

7. United States 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). [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Predictors of Patients' Responses to Spiritual Psychotherapy for Inpatient, Residential, and Intensive Treatment (SPIRIT). [2021]

9. England pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of community-based transdiagnostic psychotherapy for veterans and internally displaced persons in Ukraine. [2023]

10. England pubmed.ncbi.nlm.nih.gov

An evaluation of a common elements treatment approach for youth in Somali refugee camps. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The family empowerment program: an interdisciplinary approach to working with multi-stressed urban families. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Multisystemic therapy with substance using adolescents: a clinical and research overview]. [2008]

13. United States pubmed.ncbi.nlm.nih.gov

Tracking progress in peer-delivered family-to-family support. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Family support in prevention programs for children at risk for emotional/behavioral problems. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

The Development and Evaluation of a Parent Empowerment Program for Family Peer Advocates. [2020]