← Back to Search

Cultural-Based Intervention for Psychological Trauma in Native American Caregivers

N/A

Recruiting

Led By Teresa Brockie, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

Awards & highlights

Study Summary

This trial will develop an intervention to help reduce historical trauma and stress among Native American caregivers and improve their children's emotional and behavioral development to reduce the risk for suicide and substance abuse.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves nutritional guidance and educational components rather than medical treatments, there are no typical side effects like those seen with medications; however, emotional discomfort due to discussing traumatic experiences may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit, 6 weeks, 12 weeks, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Change in Caregiver Parenting Stress

Aim 1: Change in caregiver trauma symptoms

Secondary outcome measures

Aim 1: Adverse Childhood Experiences (ACEs)

Aim 1: Change in Caregiver Depression

Aim 1: Family routines

+12 more

Other outcome measures

Aim 1: of child: child's externalization and internalization of symptoms

Aim 1: of child: head start school attendance

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Little Holy One interventionExperimental Treatment1 Intervention

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

Group II: Nutrition controlActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,636 Total Patients Enrolled

5 Trials studying Parenting

775 Patients Enrolled for Parenting

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,045 Total Patients Enrolled

4 Trials studying Parenting

1,544 Patients Enrolled for Parenting

Annie E. Casey FoundationOTHER_GOV

5 Previous Clinical Trials

1,520 Total Patients Enrolled

Media Library

Wakȟáŋyeža (Little Holy One) Clinical Trial Eligibility Overview. Trial Name: NCT04201184 — N/A

Parenting Research Study Groups: Little Holy One intervention, Nutrition control

Parenting Clinical Trial 2023: Wakȟáŋyeža (Little Holy One) Highlights & Side Effects. Trial Name: NCT04201184 — N/A

Wakȟáŋyeža (Little Holy One) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04201184 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims are being sought to be achieved by this research endeavor?

"Across the specified timeline of Baseline, 6 weeks, 12 weeks, 6 months, 12 months 18 months and 24 months; this trial will measure Change in Caregiver Parenting Stress with the assistance of the Parenting Stress Index - Short Form. Other metrics include Change in Caregiver Perceived Stress as assessed via a 10-item questionnaire that ranges from 0 to 40 scores (with mean scores between 12-14) and no diagnostic or cut off score. Additionally, tribal identity is measured through Orthogonal Cultural Identification Scale's six questions about closeness to different cultures each accompanied by four answer choices ranging from 'A lot' to"

Answered by AI

How many subjects are participating in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the study is currently enrolling participants and was initially posted on November 18th 2019 with its most recent update released on November 15th 2022. The trial requires 120 individuals at one research site."

Answered by AI

Are individuals still being accepted for enrollment in this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively recruiting, having been first posted on November 18th 2019 and most recently updated on November 15th 2022. One site will be responsible for enrolling 120 participants in total."

Answered by AI

Recent research and studies

BMC Public HealthJournal

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, Teresa, Emily E. Haroz, Katie E. Nelson, Mary Cwik, Ellie Decker, Adriann Ricker, Shea Littlepage, et al.. 2021. “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”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-021-12272-9.

clinicaltrials.govStudy

Wakȟáŋyeža (Little Holy One)

2019. "Wakȟáŋyeža (Little Holy One)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201184.