LGBTQL-FAP OPTNCT07326748
Lakota Family Acceptance Project
A study testing Adapted Lakota Family Acceptance Program in people with LGBTQ and Racial Disparities, run by University of Michigan at 2 sites in United States.
Trial summary
The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- LGBTQ, Racial Disparities, Family Relationships
- What is being tested?
- Adapted Lakota Family Acceptance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wahwala Iyohlogya/Peaceful Means
Pine Ridge, South Dakota, 57770
He Sapa New Life Wesleyan Church
Rapid City, South Dakota, 57701
About this study
Official title: Development and Evaluation of an Indigenized Family Acceptance Project for Lakota LGBTQ2S+ Youth
The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. The investigators will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then participants will engage in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.
Read the detailed description
Research shows that Indigenous Lesbian, Gay, Bisexual, Transgender, Queer, and Two-Spirit (2SLGBTQ+) youth experience high rates of mental health problems. A key factor that leads to these challenges is family rejection (family behaviors and reactions that minimize, deny, ridicule and attempt to prevent or change a child's sexual orientation, gender identity and gender expression).
Family rejection among Indigenous 2SLGBTQ+ youth is rooted in colonization and multiple historical traumas. This includes disrupting traditional childrearing practices by forced placement in boarding schools that with other historical traumas focused on erasing Indigenous culture, including positive Two Spirit histories. Indeed, in many traditional Indigenous communities, including among the Lakota Oyate, Two Spirit relatives held important and honorable roles.
The Family Acceptance Project® (FAP) is a research, education and intervention program that was founded more than 20 years ago to help ethnically, racially and spiritually/religiously diverse parents and caregivers to learn to support and advocate for their 2SLGBTQ+ children and youth to prevent health and mental health problems and promote well-being. FAP conducted the first research on sexual minority and gender diverse youth and families and developed the first family support model to decrease family rejection and increase acceptance and support. FAP's work is grounded in the family's culture and spirituality/faith traditions.
The overall goal of the Tiwahe Tewichaglapi ("the family loves them" in Lakota) program is to apply FAP's culture-based model in the context of Lakota culture, history, and virtues. The investigators are carrying out this working partnership with community leadership to provide key family support services to 2SLGBTQ+ Lakota youth and their caregivers.
The open pilot trial (OPT) is specifically focused on assessing acceptability, feasibility, and safety of programming and research. The investigators will also use surveys to help us learn if the program impacts the project's goals above. Investigators will also ask SGMY and caregivers to share what they liked about the program and their guidance for enhancing it. This data will be used to further refine L-FAP prior to the start of the pilot RCT.
The goals of the program are to:
- Promote parent/caregiver acceptance, respect, and support for their 2SLGBTQ+ Lakota youth.
- Increase family bonding, love, support, and communication.
- Increase LGBTQ2S+ youths' feelings of pride and hope about the future.
- Reduce problems such as depression, anxiety, substance abuse, dating violence, and suicide.
- Promote bright, happy, and thriving futures for 2SLGBTQ+ Lakota youth.
Before receiving Tiwahe Tewichaglapi, SGMY (ages 13 to 18) and their caregivers will complete a survey. After completing this initial (baseline) survey, half of the families will participate in program sessions. Following the first round of sessions, all participants will complete an immediate follow-up survey. After this final survey, the other half of families will attend the program sessions.
The project includes an Advisory Board with representation from 2SLGBTQ+ Lakota youth, their caretakers, and professionals who work with 2SLGBTQ+ Lakota youth and their families, Elders and Spiritual Leaders. These individuals will provide input on key aspects of the project to ensure that it is culturally grounded and impactful for 2SLGBTQ+ Lakota youth and their caregivers.
- Conditions
- LGBTQ, Racial Disparities, Family Relationships, Minority Stress, Depression, Anxiety
- Being tested
- Adapted Lakota Family Acceptance Program
- Keywords
- family acceptance, LGBTQ, 2SLGBTQ+, youth, family support, parents of LGBTQ youth, Racial/Ethnic Minority, health equity, Native American/Indigenous, Two Spirit
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Lakota Family Acceptance ProgramBehavioural
Tiwahe Tewichaglapi ("The Family Loves Them") Program Overview
Tiwahe Tewichaglapi is a culturally grounded, family-centered intervention adapted from the Family Acceptance Project® (FAP) to promote caregiver acceptance, respect, support, and family bonding for 2SLGBTQ+ Lakota youth. The program was developed in partnership with the Lakota Oyate to address family rejection rooted in colonization and historical trauma and to honor traditional Two Spirit roles that have long held important and respected places within Lakota communities. The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, anxiety, substance use, dating violence, and suicide among 2SLGBTQ+ Lakota youth.
Tiwahe Tewichaglapi includes eight family-centered group sessions delivered by Lakota facilitators. Each session begins with Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal - to ground the
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | There is only one arm in this OPT and that is the intervention group that will participate in the 8-session LFAP intervention Receives: Behavioral: Adapted Lakota Family Acceptance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidality (Youth and Caregivers)
Participant responses to items from the Suicidal Ideation Attributes Scale to measure suicide and life-threatening behavior in the past month. The 5-item scale includes likert response options ranging from 0 = Never to 10 = Always with higher scores indicating severity of suicidal ideation.
Measured: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Depression (Youth and Caregivers)
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms.
Measured: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Anxiety (Youth and Caregivers)
Participant responses to items from the Generalized Anxiety Disorder Screener (GAD-7) to measure anxiety symptoms in the past two weeks. The 7-item scale includes likert response options ranging from 0 = not at all to 3 = Nearly every day. Higher scores indicate greater anxiety severity.
Measured: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Secondary outcomes (5)
Adolescent Dating Violence (Youth)
Participant responses to victimization and perpetration experiences in the past 30 days using items from the Adolescent Relationship Harassment and Abuse Scale on the Youth Risk Behavior Survey. The victimization scale is 21 items and the perpetration scale is 24 items. Likert response options range from 0 = 0 times to 3 = More than 10 times. Higher scores indicate greater dating violence.
Measured: Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Alcohol Use (Youth)
Participant responses to alcohol use items on the Youth Risk Behavior Survey. The 3-item scale assesses alcohol use in the past 30 days. Likert response options for items 1 and 2 range from 0 = 0 days to 6 = all 30 days. Item 3 is an 8 point scale ranging from 0 = I did not drink alcohol in the past 30 days to 8 = 10 or more drinks. Higher scores indicate greater alcohol use.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Drug Use (Youth)
Participant responses to items on drug use in the past 30 days from the Youth Risk Behavior Survey. The 8-item scale incudes likert response options ranging from 0 = 0 times to 5 = 40 or more times. Higher scores indicate greater drug use.
Measured: Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
School Engagement (Youth)
Participant response to school engagement items from the Hulsey et al., 2018 measure. The 5-item scale includes likert response options ranging from 1= Not at all true of me to 4 = Extremely true of me. Higher scores indicate increased school engagement.
Measured: Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Sexual Risk Taking (Youth)
Risky Sexual Behavioral Items from the Youth Risk Behavior Survey with participants using a slider to indicate response options ranging from 0 to 100. Higher scores indicate greater sexual risk behavior in the past 30 days.
Measured: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start20 Jan 2026
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LGBTQStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katie M Edwards, University of Michigan
- Investigators
- Katie Edwards, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326748
- Sponsor's protocol ID
- HUM00264029
- Other IDs
- 7R34MH134937-02
- Acronym
- L-FAP OPT
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Indigenized Family Acceptance Project for Lakota LGBTQ2S+ Youth
- ClinicalTrials.gov ID
- NCT07326748
- Acronym / sponsor ID
- L-FAP OPT / HUM00264029
- Conditions
- LGBTQ, Racial Disparities, Family Relationships, Minority Stress, Depression, Anxiety
- Keywords
- family acceptance, LGBTQ, 2SLGBTQ+, youth, family support, parents of LGBTQ youth, Racial/Ethnic Minority, health equity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 8 Jan 2026 (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.
The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. The investigators will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then participants will engage in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.
Detailed description
Research shows that Indigenous Lesbian, Gay, Bisexual, Transgender, Queer, and Two-Spirit (2SLGBTQ+) youth experience high rates of mental health problems. A key factor that leads to these challenges is family rejection (family behaviors and reactions that minimize, deny, ridicule and attempt to prevent or change a child's sexual orientation, gender identity and gender expression).
Family rejection among Indigenous 2SLGBTQ+ youth is rooted in colonization and multiple historical traumas. This includes disrupting traditional childrearing practices by forced placement in boarding schools that with other historical traumas focused on erasing Indigenous culture, including positive Two Spirit histories. Indeed, in many traditional Indigenous communities, including among the Lakota Oyate, Two Spirit relatives held important and honorable roles.
The Family Acceptance Project® (FAP) is a research, education and intervention program that was founded more than 20 years ago to help ethnically, racially and spiritually/religiously diverse parents and caregivers to learn to support and advocate for their 2SLGBTQ+ children and youth to prevent health and mental health problems and promote well-being. FAP conducted the first research on sexual minority and gender diverse youth and families and developed the first family support model to decrease family rejection and increase acceptance and support. FAP's work is grounded in the family's culture and spirituality/faith traditions.
The overall goal of the Tiwahe Tewichaglapi ("the family loves them" in Lakota) program is to apply FAP's culture-based model in the context of Lakota culture, history, and virtues. The investigators are carrying out this working partnership with community leadership to provide key family support services to 2SLGBTQ+ Lakota youth and their caregivers.
The open pilot trial (OPT) is specifically focused on assessing acceptability, feasibility, and safety of programming and research. The investigators will also use surveys to help us learn if the program impacts the project's goals above. Investigators will also ask SGMY and caregivers to share what they liked about the program and their guidance for enhancing it. This data will be used to further refine L-FAP prior to the start of the pilot RCT.
The goals of the program are to:
- Promote parent/caregiver acceptance, respect, and support for their 2SLGBTQ+ Lakota youth.
- Increase family bonding, love, support, and communication.
- Increase LGBTQ2S+ youths' feelings of pride and hope about the future.
- Reduce problems such as depression, anxiety, substance abuse, dating violence, and suicide.
- Promote bright, happy, and thriving futures for 2SLGBTQ+ Lakota youth.
Before receiving Tiwahe Tewichaglapi, SGMY (ages 13 to 18) and their caregivers will complete a survey. After completing this initial (baseline) survey, half of the families will participate in program sessions. Following the first round of sessions, all participants will complete an immediate follow-up survey. After this final survey, the other half of families will attend the program sessions.
The project includes an Advisory Board with representation from 2SLGBTQ+ Lakota youth, their caretakers, and professionals who work with 2SLGBTQ+ Lakota youth and their families, Elders and Spiritual Leaders. These individuals will provide input on key aspects of the project to ensure that it is culturally grounded and impactful for 2SLGBTQ+ Lakota youth and their caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Adapted Lakota Family Acceptance ProgramThere is only one arm in this OPT and that is the intervention group that will participate in the 8-session LFAP intervention |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.
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 |
|---|---|---|
| Adapted Lakota Family Acceptance ProgramTiwahe Tewichaglapi ("The Family Loves Them") Program Overview Tiwahe Tewichaglapi is a culturally grounded, family-centered intervention adapted from the Family Acceptance Project® (FAP) to promote caregiver acceptance, respect, support, and family bonding for 2SLGBTQ+ Lakota youth. The program was developed in partnership with the Lakota Oyate to address family rejection rooted in colonization and historical trauma and to honor traditional Two Spirit roles that have long held important and respected places within Lakota communities. The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, anxiety, substance use, dating violence, and suicide among 2SLGBTQ+ Lakota youth. Tiwahe Tewichaglapi includes eight family-centered group sessions delivered by Lakota facilitators. Each session begins with Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal - to ground the | Behavioural | Intervention |
Primary outcome
Suicidality (Youth and Caregivers)
Time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Participant responses to items from the Suicidal Ideation Attributes Scale to measure suicide and life-threatening behavior in the past month. The 5-item scale includes likert response options ranging from 0 = Never to 10 = Always with higher scores indicating severity of suicidal ideation.
Depression (Youth and Caregivers)
Time frame: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms.
Anxiety (Youth and Caregivers)
Time frame: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Participant responses to items from the Generalized Anxiety Disorder Screener (GAD-7) to measure anxiety symptoms in the past two weeks. The 7-item scale includes likert response options ranging from 0 = not at all to 3 = Nearly every day. Higher scores indicate greater anxiety severity.
5 secondary outcomes
Adolescent Dating Violence (Youth)
Time frame: Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Alcohol Use (Youth)
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Drug Use (Youth)
Time frame: Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
School Engagement (Youth)
Time frame: Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Sexual Risk Taking (Youth)
Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Related trials for LGBTQ
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Lakota Family Acceptance Project Pilot RCT
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Assessing the Level of Awareness Regarding the Unique Medical Needs of the LGBTQ+ Community Among Emergency Department Physicians, as Well as Their Attitudes Toward Taking Medical Histories, Examining, and Treating Patients From This Community.
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RecruitingPhase 2
Family Acceptance Project Online (Pilot RCT)
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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. This study is not recruiting at the moment.
Katie Edwards, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Lakota Family Acceptance Program in people with LGBTQ and Racial Disparities, run by University of Michigan at 2 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidality (Youth and Caregivers) (time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.