Wakȟáŋyeža (Little Holy One)

NCT04201184 | Completed DMC

• 2 other identifiers: IRB002000731R01MH115840-01A1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 2-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.

Conditions

Suicide; Trauma, Psychological; Parenting

Keywords

Native American

Outcome Measures

Primary Outcomes (2)

• Aim 1: Change in caregiver trauma symptoms

  Change in caregiver trauma symptoms will be self-reported using the Post-traumatic stress disorder (PTSD) checklist for the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 (PTSD Checklist for DSM-5, Civilian Version). This is a 20-item questionnaire. Scores range from 0-80. When used clinically a score of 33 or above indicates further assessment is needed.

  Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

• Aim 1: Change in Caregiver Parenting Stress

  Caregiver change in stress symptoms; Self-report that measures three domains of parenting stress: parental distress, parent-child dysfunctional interaction, and difficulty with child. 36-item questionnaire. Scores range from 36-180. Score ranges are represented as percentiles; 15-80 is considered a typical stress percentile, 81-89 is considered a high stress percentile, and 90-100 is considered a clinically significant stress percentile.

  Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

Secondary Outcomes (15)

• Aim 1: Change in Caregiver Depression

  Baseline visit, 12 weeks, 12 months

• Aim 1: Stressful Life Events

  Baseline visit

• Aim 1: Parents' positive childhood experiences

  Baseline visit

• Aim 1: Adverse Childhood Experiences (ACEs)

  Baseline visit

• Aim 1: Parenting practices

  Baseline visit, 12 weeks, 12 months

Other Outcomes (2)

• Aim 1: Secondary outcome of child: child's externalization and internalization of symptoms

  Baseline visit, 6 months, 12 months

• Aim 1: Secondary outcome of child: head start school attendance

  Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months

Study Arms (2)

Little Holy One intervention

EXPERIMENTAL

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

Behavioral: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules

Nutrition control

ACTIVE COMPARATOR

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.

Behavioral: Active nutrition control

Interventions

Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules BEHAVIORAL

Caregivers will receive 12 lessons, weekly, over a period of 12 weeks. Full curriculum contains: 4 lessons on cultural connection and traditions, 4 lessons on parenting adapted from Family Spirit intervention, and 4 lessons on stress and trauma adapted from CETA. modules

Little Holy One intervention

Active nutrition control BEHAVIORAL

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

Nutrition control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent or caregiver of 2-5-year-old child
• Parent or caregiver must be willing to participate in all aspects of the study including random assignment
• Parent or caregiver has been exposed to at least 1 adverse childhood event or historical trauma
• Child is an enrolled member of Fort Peck Tribes or the descent of an enrolled member

You may not qualify if:

• Parent or caregiver is under 18 years of age.
• Inability to participate in full intervention

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator
• Annie E. Casey Foundation: collaborator

Study Sites (1)

Fort Peck Tribal Head Start

Poplar, Montana, 59255, United States

Location

Related Publications (2)

• Brockie T, Haroz EE, Nelson KE, Cwik M, Decker E, Ricker A, Littlepage S, Mayhew J, Wilson D, Wetsit L, Barlow A. Wakha engyeza (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. 2021 Dec 18;21(1):2298. doi: 10.1186/s12889-021-12272-9.

  PMID: 34922510 BACKGROUND

• Wilson DH, Nelson KE, Gresh A, Ricker A, Littlepage S, Krienke LK, Brockie TN. The Pre-implementation Process of Adapting a Culturally Informed Stress Reduction Intervention for Native American Head Start Teachers. Glob Implement Res Appl. 2023;3(1):16-30. doi: 10.1007/s43477-022-00070-3. Epub 2023 Jan 9.

  PMID: 36644672 DERIVED

MeSH Terms

Conditions

Suicide; Psychological Trauma

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Teresa Brockie, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled in one of two groups; active control or intervention groups. Participants in the control group will be provided with food boxes weekly for 12 weeks. Participants in the intervention group will be taught the 12 lessons on parenting, culture, and stress over a 12-week period in individual sessions with their community health worker.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: November 18, 2019
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)