Wa’Kan Ye’Zah: Enhancing Caregivers’ and Children’s Well-being Through an Evidence-based and Culturally Informed Prevention Intervention

Overview

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wa'Kan Ye'Zah (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 3-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.

Full Title of Study: “Wa’Kan Ye’Zah (Little Holy One): Enhancing Caregivers’ and Children’s Well-being Through an Evidence-based and Culturally Informed Prevention Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2023

Detailed Description

The scientific premise of this work is rooted in understanding that high rates of historical and current trauma in Native communities compromise caregivers' mental health and parenting, which in turn affect early childhood behavior problems and adverse events that increase children's risk for suicide and substance use in adolescent and young adulthood.

Wa'Kan Ye'Zah will combine adapted elements of: 1) Common Elements Treatment Approach (CETA), an evidence-based intervention proven effective to reduce stress, depression and trauma-related symptoms, 2) Family Spirit, an evidence-based parent training program to promote positive early child development in Native American communities, and 3) cultural components informed by tribal-specific risk and protective factors for suicide and substance abuse identified in community-based studies that led to this proposal. The intervention will consist of 12 weekly individual lessons taught to parents and children (ages 3 to 5) at Head Start facilities by indigenous community health workers, a delivery strategy selected to enhance participant engagement, local acceptability and sustainability.

This study will use a randomized control trial (RCT) with an embedded single-case experimental design (SCED) to determine the effectiveness of the intervention on mental health and behavioral outcomes among N=120 parent-child dyads, while empirically exploring the added benefit of specific cultural components on parent/caregiver outcomes. on mental health and behavioral outcomes among N=120 parent-child dyads, while exploring the added benefit of cultural components on parent outcomes. The study plan is situated within a well-established trust relationship with tribal communities, innovative formative research that led to this proposal, and an experienced, multi-disciplined study team led by an Indigenous Principle Investigator.

Interventions

  • Behavioral: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules
    • 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
  • Behavioral: Active nutrition control
    • The six 30-minute voluntary nutrition education sessions will be taught one-on-one to parents and children at the school with information about where to obtain healthy foods. Parents will also be given healthy recipes and sample easy-to-make healthy foods with the children.

Arms, Groups and Cohorts

  • Experimental: Little Holy One intervention
    • The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 12 weeks.
  • Active Comparator: Nutrition control
    • The participants will receive 6 1-hour lessons on nutrition over a period of 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in caregiver trauma symptoms as assessed by the PTSD Checklist for DSM-5
    • Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
    • 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.
  • Change in Caregiver Parenting Stress as assessed by the Parenting Stress Index – Short Form
    • Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
    • 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.

Secondary Measures

  • Change in Caregiver Depression as assessed by the Center for Epidemiologic Studies Depression Scale-Revised
    • Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
    • Self-reported depression systems, 10-item questionnaire. Scores range from 0-30, with a score of 10 or greater indicating clinically significant symptoms of depression.
  • Change in Caregiver Perceived Stress as assessed by the Perceived Stress Scale
    • Time Frame: Before the first session and at each weekly session, up to 12 weeks
    • Self-reported stress. 10-item questionnaire. Scores range from 0-40, with mean scores falling between 12-14. There are no diagnostic or cut off scores for this measure, however, high scores indicate higher levels of reprieved parenting stress.
  • Caregiver Substance Use as assessed by the adapted Centers for Disease Control Youth Risk Behavior Surveillance Survey
    • Time Frame: At baseline visit, up to 15 minutes
    • Self-reported first use, lifetime, and current frequency of substance use will be assessed with the adapted Centers for Disease Control Youth Risk Behavior Surveillance Survey which has 29 questions. This measure does not include a numerical score.
  • Change in Caregiver Parenting Practices as assessed by 72-item interview
    • Time Frame: Baseline, 6 weeks, 12 weeks, 6 months, and 12 months
    • 72-item Interview used to assess disciplinary style of caregiver, across seven discipline scales: Harsh Discipline (14 items), Harsh for Age (9 items), Inconsistent Discipline (6 items), Appropriate Discipline (16 items), Positive Parenting (15 items), Clear Expectations (3 items), and Monitoring (9 items). Each item is rated on a scale from 1 (never) to 7 (always) for a score range of 72-504. There are no diagnostic or cut off scores for this measure. Averages for each scale can be used to assess disciplinary style, caregivers who need further evaluation, or as a measure of change following an intervention.
  • Change in Caregiver Communal Mastery as assessed by 10-item questionnaire
    • Time Frame: Before the first session and at each weekly session, up to 12 weeks
    • Self-reported communal mastery and self-efficacy, 10-item questionnaire. Scores range from 10-40. Higher scores indicate greater communal mastery, however, there are no diagnostic or cut-off scores for this measure.
  • Change in Caregiver Tribal Identity as assessed by the Orthogonal Cultural Identification Scale
    • Time Frame: Before the first session and at each weekly session, up to 12 weeks
    • A 6-item questionnaire, each question includes three parts asking about how close subject is to different cultures. Each question has 4 answer choices from ‘A lot’ to ‘Not at all’. There is no total score for this questionnaire.
  • Change in Child Internalizing and Externalizing symptoms as assessed by the Child Behavior Checklist
    • Time Frame: Baseline, 6 weeks, 12 weeks, 18 months, 24 months
    • 99-item Checklist is completed by child’s primary caregiver and teacher, evaluates behavioral and emotional problems in preschool children. Children’s scores can range from 0-200 and are represented as percentiles, with 50 percentile indicating average, any score below 93 indicating normal behaviors, and above 97 percentile indicating clinical range.

Participating in This Clinical Trial

Inclusion Criteria

  • Parent or caregiver of 3-5-year-old child enrolled in Head Start
  • Parent or caregiver must have experienced trauma

Exclusion Criteria

  • Parent or caregiver is under 18 years of age.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Teresa Brockie, PhD, Principal Investigator, Johns Hopkins University
  • Overall Contact(s)
    • Teresa Brockie, PhD, 410-955-1730, tbrocki1@jhu.edu

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