What side effects are associated with this type of intervention?

Common treatments for parenting interventions, such as those aimed at reducing historical trauma and stress, improving parenting, and enhancing children's emotional and behavioral development, often include psychological therapies, stress reduction techniques, and behavioral interventions. Known side effects of these treatments can include temporary increases in emotional distress as individuals confront and process traumatic experiences, fatigue from the emotional effort involved, and occasional resistance or frustration from both parents and children as they adapt to new behaviors and routines. However, these side effects are generally mild and tend to diminish as participants progress through the intervention.

What prior FDA approvals exist?

The FDA has approved several medications for conditions that indirectly support parenting and child development, such as anxiety, depression, and behavioral disorders in children. These include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, which are used to treat pediatric anxiety and depression, and atypical antipsychotics like risperidone, which are used for irritability associated with autism. While these medications do not directly address parenting or historical trauma, they can help manage symptoms in children that may improve overall family dynamics and support better parenting outcomes.

What other types of research exist?

Promising alternatives to the Wakȟáŋyeža intervention include: 1) Parent-Child Interaction Therapy (PCIT), which focuses on improving the quality of the parent-child relationship and changing parent-child interaction patterns; 2) The Incredible Years program, which aims to reduce children's behavioral problems and increase social competence through parent training; 3) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which is designed to help children and their caregivers overcome the impact of traumatic events; and 4) Circle of Security, which enhances attachment security between parents and children by improving parents' understanding of their children's emotional needs.

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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 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

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.

0 / 1Eligibility criteria met

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.

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