About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver)
Identify as Indigenous (multiracial youth who are also Indigenous are eligible)
Youth should be between the ages of 13 and 18 years
Read and speak English
Disqualifiers
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 design
Single group
Treatments tested in this trial
Adapted Lakota Family Acceptance Program
BehavioralTiwahe 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
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
(Intermediary Outcome) Caregiver Accepting and Rejecting Behaviors (Youth and Caregivers)
FAP-Reactions, Advocacy, Feelings/Experiences is a 34 item measure with a 4 point scale for items 1-30 0=Never to 3=Many times. Higher scores indicate more accepting behavior in the past 30 days. A 5 point scale for items 31-32 1=Very Upset to 5=Very Happy with higher scores indicating accepting behavior for item 31 and rejecting behavior for item 32; items 33-34 1=Extremely to 5=Not At All with higher scores indicating accepting behavior for item 33 and rejecting behavior for item 34 in the past 30 days. LGBTQ microaggressions and anti-LGBTQ attitudes (reactions and feelings from microaggressions) subscale is 8 items with a 5 point scale 0=Never to 4=All the time. Higher scores suggest experiencing more interpersonal microaggressions in the past 30 days.
(Intermediary Outcome) Harsh Parenting (Youth and Caregivers)
Items from the Brief Family Relationship Scale to assess family conflict. The 6-item scale includes response options using a continuous slider scale ranging from 1 to 20. Higher scores indicate greater conflict.
(Intermediary Outcome) Connection to Lakota Culture (Youth and Caregivers)
Participant responses to items on the Lakota Cultural Identity Scale. The 7-item scalre includes likert response options ranging from 1 = Not at all to 4 = A lot. Higher scores indicate greater connection to Lakota culture.
(Intermediary Outcome) Connection to Community (Youth and Caregivers)
Participant responses to the Sense of Community Index. The 25-item scale includes likert response options ranging from 1 = Not at all to 4 = Very Important. Higher scores indicate greater sense of community.
Sponsors and contacts
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University of Michigan
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator