Depressive SymptomsFSSNCT05836090
Family Spirit Strengths
A study testing Family Spirit Strengths (FSS) and Family Spirit Nurture in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Depressive Symptoms, Anxiety Disorders and Symptoms, Substance Use
- What is being tested?
- Family Spirit Strengths (FSS) and Family Spirit Nurture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-identify as female; and
- Pregnant or be a primary caregiver of a child that is 24 months or younger; and
- 14 years or older at time of enrollment; and
- Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
- Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
- Be part of the service population of one of the participating sites.
Who cannot join
- Profound disability that limits the ability to participate in assessments or interventions; and
- Unlikely to be residing in or near the research service area for the next 6 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Center for Indigenous Health
Chinle, Arizona, 86503
Brandy Begay, 928-674-6824, bbegay4@jh.edu
- Recruiting
Pokagon Health Services
Pokagon, Michigan, 49047
Elizabeth Leffler, 269-462-4406, Elizabeth.Leffler@pokagonband-nsn.gov
- Recruiting
Johns Hopkins Center For Indigenous Health
Shiprock, New Mexico, 87420
Leonela Nelson, MPH, lnelso32@jhu.edu
About this study
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.
- Being tested
- Family Spirit Strengths (FSS), Family Spirit Nurture
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Spirit Strengths (FSS)Behavioural
The FSS intervention consists of psychoeducational components that emphasize the importance of mental and emotional health as part of overall wellness, and seek to normalize experiences of stress, to de-stigmatize help-seeking, and to build hope. Core content focuses on awareness of the connections between thoughts, feelings, behaviors, and spirituality, and imparts related self-help skills. It also specifically builds in connection to culture, land and others as coping strategies. The FSS lessons were developed based on culturally adapting the Common Elements Treatment Approach (CETA).
Family Spirit NurtureBehavioural
The active control Family Spirit Nurture, is an evidence-based nutrition education curriculum that has been previously tested with Navajo communities which focuses on age-appropriate parental feeding practices, including snack routines, avoidance of sugar-sweetened beverages (SSB) and promotion of water consumption.
| Study group | Role | What they receive |
|---|---|---|
| Family Spirit Strengths (FSS) | Experimental | 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. Receives: Behavioral: Family Spirit Strengths (FSS) |
| Family Spirit Nurture | Active comparator | 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. Receives: Behavioral: Family Spirit Nurture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-up timepoint.
Measured: baseline, 6-9 months post baseline
Secondary outcomes (6)
Days of alcohol or drug use measured by adapted Timeline Follow-Back (TLFB)
The adapted TLFB records daily substance use during the past 2 weeks. The outcome is the number of days with any alcohol, cannabis, or other drug use, including recreational use of prescription medication (0-14 days). Each day counts once regardless of the number of substances used. Higher values indicate more days of use. The questionnaire also collects alcohol quantities and nicotine use.
Measured: baseline, 3-6 months post baseline, 6-9 months post baseline
Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
Centers for Epidemiological Research Revised 10 item scale (CESDR-10). This 10-item screening measure is used to identify individuals who are at high-risk for major depressive disorder. It asks respondents to rate the frequency of specific depressive symptoms in the past two weeks. The more often depressive symptoms that are experienced by the respondent and the more depressive symptoms they experience in general, the higher the risk for major depressive disorder. The average score range for this measure is 0-3. An average score of 0.80 and over is considered high risk and warrants a referral for additional support. A score lower than 0.80 is considered at lower risk and no referral is necessary.
Measured: baseline, 3-4 months post baseline, 6-9 months post baseline
Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Patient-Reported Outcomes Measurement Information System (PROMIS) short form. This 8-item anxiety screening tool asks respondents to rate how often they feel anxiety symptoms in the past 7 days. Items focus on feeling fearful, anxious, worried, nervous, uneasy, tense, and unable to focus on anything other than anxiety. The more often anxiety symptoms are experienced by the respondent and the more anxiety symptoms they experience in general, the higher the risk for an anxiety disorder. The average score range for this measure is 1-5. An average score of 2.125 and above is considered high risk, warrants a referral for additional support. Scores lower than 2.125 average score are considered at lower risk and no referral is necessary.
Measured: baseline, 3-6 months post baseline, 6-9 months post baseline
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
As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-up timepoint.
Measured: baseline, 3-4 months post baseline
Alcohol involvement measured by the adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
The alcohol score is the mean of 6 items assessing frequency of use, desire to use, problems related to use, failure to meet obligations, concern expressed by others, and unsuccessful efforts to reduce use. Items on use, desire, problems, and obligations refer to the past month. The last 2 distinguish never, within the past month, and before the past month. Scores range from 0 to 6.5, with higher scores indicating greater alcohol involvement. Analysis includes participants reporting alcohol use at baseline.
Measured: Baseline; post-intervention (3-4 months after baseline); final follow-up (6- 9 months).
Drug involvement measured by the adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
The drug score is the mean of 6 parallel items about illegal drugs or legal drugs used other than as prescribed. Drug types are assessed together. Items on use, desire, problems, and obligations refer to the past month. Concern expressed by others and unsuccessful efforts to reduce use distinguish never, within the past month, and before the past month. Scores range from 0 to 6.5, with higher scores indicating greater drug involvement. Analysis includes participants reporting drug use at baseline.
Measured: Baseline; post-intervention (3-4 months after baseline); final follow-up (6- 9 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start20 Apr 2023
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Haroz, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836090
- Sponsor's protocol ID
- IRB00023017
- Acronym
- FSS
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson L, Lopez LM, Archuleta S, Van Wyk SS, Kushman E, Martin L, Mitchell K, Leffler E, Werwie TR, Kemp CG, Cuddy RF, Haroz EE. Testing the effectiveness of Family Spirit Strengths (FSS) - a culturally informed intervention designed to prevent mental health and substance misuse for indigenous families through home visiting. BMC Public Health. 2026 Feb 26;26(1):1085. doi: 10.1186/s12889-026-26593-0.
PubMed 41749230
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Spirit Strengths
- ClinicalTrials.gov ID
- NCT05836090
- Acronym / sponsor ID
- FSS / IRB00023017
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Spirit Strengths (FSS) | Experimental | Behavioral: Family Spirit Strengths (FSS)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. |
| Family Spirit Nurture | Active comparator | Behavioral: Family Spirit NurtureParticipants 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as female; and
- Pregnant or be a primary caregiver of a child that is 24 months or younger; and
- 14 years or older at time of enrollment; and
- Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
- Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
Key exclusion criteria (2 listed)
- Profound disability that limits the ability to participate in assessments or interventions; and
- Unlikely to be residing in or near the research service area for the next 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Spirit Strengths (FSS)The FSS intervention consists of psychoeducational components that emphasize the importance of mental and emotional health as part of overall wellness, and seek to normalize experiences of stress, to de-stigmatize help-seeking, and to build hope. Core content focuses on awareness of the connections between thoughts, feelings, behaviors, and spirituality, and imparts related self-help skills. It also specifically builds in connection to culture, land and others as coping strategies. The FSS lessons were developed based on culturally adapting the Common Elements Treatment Approach (CETA). | Behavioural | Family Spirit Strengths (FSS) |
| Family Spirit NurtureThe active control Family Spirit Nurture, is an evidence-based nutrition education curriculum that has been previously tested with Navajo communities which focuses on age-appropriate parental feeding practices, including snack routines, avoidance of sugar-sweetened beverages (SSB) and promotion of water consumption. | Behavioural | Family Spirit Nurture |
Primary outcome
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
Time frame: baseline, 6-9 months post baseline
As measured by the single item on the Health-Related Quality of Life (HRQOL) which asks responders to identify how many days in the past 30 day they experience bad or poor mental health. Scores may range from 0-30 where 0 indicates the participant did not experience any poor mental health days in the last 30 days and 30 indicates the participant experienced a poor mental health day every day in the last 30 days. A difference in mean for the past 30 days will be calculated at the 6 month follow-up timepoint.
6 secondary outcomes
Days of alcohol or drug use measured by adapted Timeline Follow-Back (TLFB)
Time frame: baseline, 3-6 months post baseline, 6-9 months post baseline
Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
Time frame: baseline, 3-4 months post baseline, 6-9 months post baseline
Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Time frame: baseline, 3-6 months post baseline, 6-9 months post baseline
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
Time frame: baseline, 3-4 months post baseline
Alcohol involvement measured by the adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline; post-intervention (3-4 months after baseline); final follow-up (6- 9 months).
Drug involvement measured by the adapted Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline; post-intervention (3-4 months after baseline); final follow-up (6- 9 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 41749230Nelson L, Lopez LM, Archuleta S, Van Wyk SS, Kushman E, Martin L, Mitchell K, Leffler E, Werwie TR, Kemp CG, Cuddy RF, Haroz EE. Testing the effectiveness of Family Spirit Strengths (FSS) - a culturally informed intervention designed to prevent mental health and substance misuse for indigenous families through home visiting. BMC Public Health. 2026 Feb 26;26(1):1085. doi: 10.1186/s12889-026-26593-0.
- Johns Hopkins Center for Indigenous Health Family Spirit Strengths program descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Haroz principal investigator
Johns Hopkins Bloomberg School of Public Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Spirit Strengths (FSS) and Family Spirit Nurture in people with Depressive Symptoms and Anxiety Disorders and Symptoms, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Haroz, PhD (410-449-0051, eharoz1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline, 6-9 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.