Cultural-Based Intervention for Psychological Trauma in Native American Caregivers

Overseen By Teresa Brockie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Inability to participate

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support Native American caregivers and their young children by addressing psychological trauma and everyday stress. Participants will receive lessons on parenting, stress management, and cultural teachings through the Wakȟáŋyeža (Little Holy One) program. The goal is to enhance parenting skills and improve children's emotional and behavioral development, reducing future risks of issues like suicide and substance use. Caregivers who have experienced adverse childhood events and care for a child aged 2-5 who is a member or descendant of the Fort Peck Tribes may be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored support programs for Native American families.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Wakȟáŋyeža (Little Holy One) intervention is safe for Native American caregivers and their children?

Research has shown that the Wakȟáŋyeža (Little Holy One) program is still under study, and specific safety information is not yet available. The trial's "Not Applicable" phase designation indicates that the program is in the early stages of research, focusing more on development than detailed safety studies.

The program includes educational sessions on parenting, stress, and culture. Such programs are generally considered low-risk because they do not involve medication or medical procedures. However, while educational programs are usually well-tolerated, detailed safety information is still being collected.

Prospective participants should consider these points and discuss any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wakȟáŋyeža (Little Holy One) intervention because it offers a culturally tailored approach to treating psychological trauma in Native American caregivers. Unlike standard treatments that may not consider cultural factors, this intervention incorporates lessons on parenting, stress, and culture, which can resonate deeply with participants' cultural identities. This personalized method could lead to more effective healing by addressing the unique cultural needs and experiences of Native American caregivers, potentially setting a new standard for culturally informed trauma care.

What evidence suggests that the Wakȟáŋyeža (Little Holy One) intervention is effective for reducing psychological trauma in Native American caregivers?

Research has shown that the Wakȟáŋyeža (Little Holy One) program, one of the interventions in this trial, is designed to help Native American communities by addressing issues like trauma, suicide, and substance use that can affect multiple generations. This program aims to lower stress and trauma symptoms in caregivers and improve their parenting skills. By doing so, it seeks to support better emotional and behavioral development in children. While specific results are still under study, the program is based on cultural traditions, which are important for healing historical trauma. Early findings suggest that programs rooted in cultural practices can positively impact mental health and parenting in Native American families. Participants in another arm of this trial will receive a nutrition control intervention, which includes nutrition information, weekly food boxes, and recipes based on seasonal foods. ^{1 3 4 5 6}

Who Is on the Research Team?

Teresa Brockie, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for Native American caregivers on a Northern Plains reservation with children aged 2-5. Participants must have experienced trauma or stress and be willing to join all study parts, including random assignment. Children should be members or descendants of the Fort Peck Tribes.

Inclusion Criteria

Child is an enrolled member of Fort Peck Tribes or the descent of an enrolled member

Parent or caregiver must be willing to participate in all aspects of the study including random assignment

The parent or caregiver has experienced a traumatic event during their childhood or in the past.

Exclusion Criteria

My parent or caregiver is younger than 18.

I cannot fully participate in the treatment plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive 12 weekly individual lessons on parenting, stress, and culture at Head Start facilities

16 weeks

12 visits (in-person)

Follow-up

Participants are monitored for mental health and behavioral outcomes after the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Wakȟáŋyeža (Little Holy One)

Trial Overview The 'Wakȟáŋyeža (Little Holy One)' intervention includes active nutrition control, cultural components, adapted parenting lessons from Family Spirit, and CETA modules to reduce trauma symptoms in parents and improve child development outcomes.

How Is the Trial Designed?

Group I: Little Holy One intervention Experimental Treatment 1 Intervention

The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks.

Group II: Nutrition control Active Control 1 Intervention

The active control condition will receive nutrition information, weekly food boxes and recipes based on seasonal foods, as well as a shopping list for making future meals.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Annie E. Casey Foundation

Collaborator

Trials

6

Recruited

1,600+

Published Research Related to This Trial

A study involving 74 ethnographic interviews with 37 Diné youth, parents, and grandparents found that addressing historical trauma is crucial for understanding behavioral health inequities among Diné youth.

The research emphasizes the importance of current stressors like poverty and violence, and suggests that interventions should incorporate traditional knowledge and culturally based healing practices to promote resilience and social transformation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"We're still in a struggle": Diné resilience, survival, historical trauma, and healing. Goodkind, JR., Hess, JM., Gorman, B., et al.[2021]

The Little Holy One intervention was successfully adapted for Head Start teachers on the Fort Peck Native American Reservation to address their high stress levels and support needs, using a participatory approach that involved community input from 27 teachers and parents.

This adaptation process, guided by the ADAPT-ITT methodology, emphasizes the importance of cultural relevance in mental health interventions, potentially improving psychological health outcomes for Native Americans who may not typically access traditional psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pre-implementation Process of Adapting a Culturally Informed Stress Reduction Intervention for Native American Head Start Teachers. Wilson, DH., Nelson, KE., Gresh, A., et al.[2023]

Interviews with 19 staff and clients at a Native American healing lodge revealed that addressing historical trauma involves recognizing and confessing pain, which is linked to adult dysfunction like substance abuse.

The healing process emphasizes the importance of reclaiming indigenous heritage and spirituality, suggesting that culturally sensitive approaches can effectively address the impacts of colonization and promote self-improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based treatment for Native American historical trauma: prospects for evidence-based practice. Gone, JP.[2009]

Native American and Alaska Native people face a higher incidence of traumatic events and are more susceptible to posttraumatic stress disorder, highlighting a significant public health concern.

Interviews with six Native healers revealed key themes related to trauma, emphasizing the importance of cultural competence in healthcare to better support Native trauma patients and improve their recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Our culture is medicine": perspectives of Native healers on posttrauma recovery among American Indian and Alaska Native patients. Bassett, D., Tsosie, U., Nannauck, S.[2022]

The Honoring Children, Mending the Circle (HC-MC) treatment is an adaptation of trauma-focused cognitive-behavioral therapy specifically designed for American Indian and Alaska Native populations, addressing their unique experiences with trauma.

HC-MC integrates traditional AI/AN teachings with cognitive-behavioral methods, providing a culturally relevant approach to therapy that aims to improve the mental health outcomes for these vulnerable communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Honoring children, mending the circle: cultural adaptation of trauma-focused cognitive-behavioral therapy for American Indian and Alaska native children. BigFoot, DS., Schmidt, SR.[2022]

Indigenous adults in the USA face a high risk of mental health issues such as PTSD, depression, suicide, and substance use disorders, largely influenced by historical oppression and family problems.

Protective factors like family support and engagement in tribal cultural activities can help mitigate these risks, suggesting that holistic approaches are essential for effective mental health interventions in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Culturally Informed Systematic Review of Mental Health Disparities Among Adult Indigenous Men and Women of the USA: What is known? Ka'apu, K., Burnette, CE.[2020]

The Wakȟáŋyeža (Little Holy One) intervention is a culturally-based program aimed at reducing intergenerational trauma and improving parenting among Fort Peck Assiniboine and Sioux families, utilizing a randomized controlled trial design with 1:1 randomization of parent-child dyads.

The intervention focuses on addressing trauma symptoms and stress in parents, with secondary outcomes including improvements in parenting practices and child behavior, suggesting a potential upstream approach to reduce children's risk for substance use and suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wakȟáŋyeža (Little Holy One) - an intergenerational intervention for Native American parents and children: a protocol for a randomized controlled trial with embedded single-case experimental design. Brockie, T., Haroz, EE., Nelson, KE., et al.[2022]

The Iwankapiya study involved 52 American Indian adults and tested a combined intervention of Historical Trauma and Unresolved Grief Intervention (HTUG) with Group Interpersonal Psychotherapy (IPT) over 12 sessions, aiming to reduce depression and trauma symptoms.

While both treatment groups showed significant decreases in depression scores, HTUG + IPT led to greater group engagement, suggesting that this combined approach may enhance treatment participation, which is crucial for communities facing high levels of trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iwankapiya American Indian pilot clinical trial: Historical trauma and group interpersonal psychotherapy. Brave Heart, MYH., Chase, J., Myers, O., et al.[2022]

Native American families possess strong resilience despite facing challenges like oppression and poverty, which can lead to mental health issues.

Cultural traditions that promote harmony can enhance mental health in Native American children and adolescents, highlighting the importance of culturally sensitive practices in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Native American children and adolescents: cultural distinctiveness and mental health needs. Keltner, BR.[2019]

The article highlights the unique challenges of providing mental health services to isolated urban Native Americans living with HIV, who often face multiple trauma-related issues and have a deep distrust of traditional treatment methods.

Integrating art therapy and in-home therapy into mental health services can effectively support individuals who struggle to express their emotions verbally, thereby respecting their cultural context and addressing their specific mental health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Art therapy as emotional and spiritual medicine for Native Americans living with HIV/AIDS. Bien, MB.[2007]

Citations

1. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-12272-9

Wakȟáŋyeža (Little Holy One) | BMC Public Health | Full Text Designed to break cycles of intergenerational trauma, suicide, and substance use among Fort Peck Assiniboine and Sioux parents and their children.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34922510/

an intergenerational intervention for Native American parents ... Designed to break cycles of intergenerational trauma, suicide, and substance use among Fort Peck Assiniboine and Sioux parents and their children.

3. clinicaltrial.be clinicaltrial.be/en/details/59393?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Wakȟáŋyeža (Little Holy One) The scale quantifies 12 types of losses that Native American tribes might have experienced in the past, how often they are thought about in ...

4. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/wak%C8%9F%C3%A1%C5%8Bye%C5%BEa-little-holy-one-an-intergenerational-intervention-for-/

Wakȟáŋyeža (Little Holy One) - an intergenerational ... The objective of this manuscript is to describe the Wakȟáŋyeža (Little Holy One) intervention and evaluation protocol, that is designed to break cycles of ...

5. researchgate.net researchgate.net/publication/357163027_Wakhanyeza_Little_Holy_One_-_an_intergenerational_intervention_for_Native_American_parents_and_children_a_protocol_for_a_randomized_controlled_trial_with_embedded_single-case_experimental_design

(PDF) Wakȟáŋyeža (Little Holy One) - an intergenerational ... PDF | Background Trauma within Native American communities compromises parents' parenting capacity; thus, increasing childrens' risk for substance use.

6. withpower.com withpower.com/trial/phase-psychological-trauma-10-2019-3e172

Cultural-Based Intervention for Psychological Trauma in Native ... The available research does not provide specific safety data for the Wakȟáŋyeža (Little Holy One) intervention. However, the intervention is being evaluated ...