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Family Spirit Strengths (FSS)

Primary Purpose

Depressive Symptoms, Anxiety Disorders and Symptoms, Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Spirit Strengths (FSS)
Family Spirit Nurture
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Symptoms

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Center For Indigenous Health - ShiprockRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Spirit Strengths (FSS)

Family Spirit Nurture

Arm Description

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.

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.

Outcomes

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
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.

Secondary Outcome Measures

Change in Substance Use as measure by the Timeline Follow Back for Substance Use
Timeline Follow Back for substance use is a 21 item assessment tool used to measure substance use. Domains measured by this tool include alcohol, marijuana, other drugs, and cigarette use. Participants will be asked to report on any use within the past two weeks. This tool uses standard units of alcoholic beverages, in which each count as one drink. The average alcohol score ranges from 0-4. An average score of 2 or above indicates some level of risk and warrants a referral for additional support. The average drug use score range is 0-6. An average score of 1 or above indicates some level of drug use risk and a referral for additional support will be made. The average score range for injection drug use is 0-3. An average injection drug use score of 1 or higher indicates some level of risk and a referral for additional support will be made. For any score of less than scores stated above as being high risk will be considered low risk and no referral is necessary.
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.
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 0-4. 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.

Full Information

First Posted
April 18, 2023
Last Updated
July 26, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT05836090
Brief Title
Family Spirit Strengths
Acronym
FSS
Official Title
Family Spirit Strengths
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety Disorders and Symptoms, Substance Use, Mental Health Issue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family Spirit Strengths (FSS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Family Spirit Nurture
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Spirit Strengths (FSS)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Family Spirit Nurture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
baseline, 3-4 months post baseline, 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in Substance Use as measure by the Timeline Follow Back for Substance Use
Description
Timeline Follow Back for substance use is a 21 item assessment tool used to measure substance use. Domains measured by this tool include alcohol, marijuana, other drugs, and cigarette use. Participants will be asked to report on any use within the past two weeks. This tool uses standard units of alcoholic beverages, in which each count as one drink. The average alcohol score ranges from 0-4. An average score of 2 or above indicates some level of risk and warrants a referral for additional support. The average drug use score range is 0-6. An average score of 1 or above indicates some level of drug use risk and a referral for additional support will be made. The average score range for injection drug use is 0-3. An average injection drug use score of 1 or higher indicates some level of risk and a referral for additional support will be made. For any score of less than scores stated above as being high risk will be considered low risk and no referral is necessary.
Time Frame
baseline, 3-4 months post baseline, 6 months post baseline
Title
Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10)
Description
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.
Time Frame
baseline, 3-4 months post baseline, 6 months post baseline
Title
Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form
Description
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 0-4. 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.
Time Frame
baseline, 3-4 months post baseline, 6 months post baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identifies as female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Haroz, PhD
Phone
410-449-0051
Email
eharoz1@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leonela Nelson, MPH
Phone
505-368- 4234
Email
lnelso32@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Haroz
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center For Indigenous Health - Shiprock
City
Shiprock
State/Province
New Mexico
ZIP/Postal Code
87420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonela Nelson, MPH
Email
lnelso32@jhu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Family Spirit Strengths

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