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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
Must not have
Parent or caregiver is under 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a program called 'Wakȟáŋyeža' for Native American caregivers and their young children. It aims to reduce stress and trauma, improve parenting skills, and support children's development using culturally relevant methods. The program includes lessons on managing stress, better parenting, and promoting healthy child growth. The Wakȟáŋyeža program is an intergenerational intervention designed for Native American parents and children, incorporating unique cultural lesson-components to improve parent-child outcomes.

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My parent or caregiver is younger than 18.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aim 1: Change in Caregiver Parenting Stress
Aim 1: Change in caregiver trauma symptoms
Secondary study objectives
Aim 1: Adverse Childhood Experiences (ACEs)
Aim 1: Change in Caregiver Depression
Aim 1: Family routines
+12 more
Other study objectives
Aim 1: of child: child's externalization and internalization of symptoms
Aim 1: of child: head start school attendance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for parenting, particularly those addressing historical trauma and stress, include cognitive-behavioral therapy (CBT), mindfulness practices, and parent-child interaction therapy (PCIT). These interventions work by equipping parents with strategies to manage stress, improve emotional regulation, and enhance positive interactions with their children. This is vital for parenting patients as it helps reduce their own trauma and stress symptoms while promoting healthier emotional and behavioral development in their children, ultimately lowering the risk of future psychological problems.
In-home parent training, treatment of migraine headaches, and marital counseling as an ecobehavioral approach to prevent child abuse.Treatment effectiveness of a mindfulness-based inpatient group psychotherapy in adolescent substance use disorder - study protocol for a randomized controlled trial.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,905 Previous Clinical Trials
2,738,677 Total Patients Enrolled
7 Trials studying Parenting
1,000 Patients Enrolled for Parenting
Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,821 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
~24 spots leftby Jan 2026