Wakȟáŋyeža (Little Holy One)
Primary Purpose
Suicide, Trauma, Psychological, Parenting
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules
Active nutrition control
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Native American
Eligibility Criteria
Inclusion Criteria:
- Parent or caregiver of 3-5-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
Exclusion Criteria:
- Parent or caregiver is under 18 years of age.
- Inability to participate in full intervention
Sites / Locations
- Fort Peck Tribal Head StartRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Little Holy One intervention
Nutrition control
Arm Description
The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Aim 1: Change in Caregiver Depression
The CESD-R-10 is comprised of 10 items based on DSM-IV diagnostic criteria for Major Depressive Disorder. Scores range of 0-30, with a score greater than eight indicate clinically significant symptoms. The CESD-R-10 is based on the CESD, a widely validated instrument, including among Native American populations.
Aim 1: Stressful Life Events
The Stressful Life Events Screening Questionnaire (SLESQ) is a 13-item self-report questionnaire designed to assess lifetime exposure to potentially traumatic events. It has been used in several culturally diverse settings and is recommended for use for research purposes.
Aim 1: Parents' positive childhood experiences
Parents' positive childhood experiences will be measured by self-report at baseline with the Benevolent Childhood Experiences Scale. This is a 10-item scale designed to assess positive childhood experiences in adults with experience of mistreatment or adversity.
Aim 1: Adverse Childhood Experiences (ACEs)
Parents' ACEs will be measured by self-report at baseline with a 23-item ACEs scale adapted to the study population.
Aim 1: Parenting practices
Parenting practices will be measured by the Parenting Practices Interview (PPI), a 72-item self-report questionnaire adapted from the Oregon Social Learning Center's Discipline Questionnaire and revised for young children. It measures the disciplinary style of a parent and has been used in a variety of settings and populations.
Aim 1: Parental control
Parental control will be measured by the Parental Locus of Control Scale (PLOC), a 47-item questionnaire which measures five factors to assess the locus of control a parent or caregiver has over a child.
Aim 1: Family routines
Family routines will be measured via self-report using the Family Routines Index, a 28-item questionnaire which measures 10 areas of family routines
Aim 1: Parent substance use
Parent substance use will be measured via self-report using an adapted version of the 15-item WHO ASSIST Questionnaire, which screens for problematic or risky substance use. A risk score is provided for each of the 10 substances included in the survey. The ASSIST is reliable, valid, flexible, comprehensive, and cross-culturally relevant having been validated with populations all over the world.
Aim 1: Parent historical loss experiences
Parent historical loss experiences will be assessed via self-report at baseline with the Historical Loss Scale. The scale quantifies 12 types of losses that Native American tribes might have experienced in the past, how often they are thought about in the present, and 12 different symptoms that they might have because of thinking about these losses. This scale has been used in previous studies and in several Native American populations.
Aim 1: Parental communal mastery
Parent communal mastery will be measured via self-report using the 10-item Communal Mastery Scale, which was developed specifically for Native contexts using two commonly employed measures of mastery and self-efficacy and adapted to add more collectivist statements. This scale was successfully used in a previous study at Fort Peck.
Aim 1: Parent tribal identity
Parent tribal identity will be assessed using a modified version of the 6-item Orthogonal Cultural Identification Scale. The scale has been adapted for Assiniboine and Sioux tribal identity and was also used in a previous study on the Fort Peck Reservation.
Aim 1: Parental experiences related to historical trauma
Parents' experiences related to historical trauma will be measured by the Historical Trauma Checklist. This measure is a 15-item checklist, developed from focus group discussions with the Fort Peck Reservation. Three questions are posed to determine relevant historical trauma experiences.
Aim 2: Parent stress
Parent stress will be measured using the Perceived Stress Scale (PSS). The PSS is a 10-item scale that has been widely used and validated, including in Native American populations.
Aim 3: Social networks information
Social networks information will be collected via a 17-item self-report Caregiver Ego Networks Questionnaire. Parents will provide information about tribal affiliation, relationships, substance use, communication, parenting support, and cultural involvement of up to 10 of their closest social relationships.
Aim 3: Suicide risk
Suicide risk will be measured with six items from the Columbia Suicide Severity Rating Scale (CSSR-S), which has been widely used to identify and assess individuals at risk for suicide across diverse communities and settings.
Full Information
NCT ID
NCT04201184
First Posted
December 13, 2019
Last Updated
December 5, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH), Annie E. Casey Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04201184
Brief Title
Wakȟáŋyeža (Little Holy One)
Official Title
Wakȟáŋyeža (Little Holy One): Enhancing Caregivers' and Children's Well-being Through an Evidence-based and Culturally Informed Prevention Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH), Annie E. Casey Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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' 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.
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.
Wakȟáŋyeža 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. 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.
A supplement has been added to this clinical trial, the goal of the supplement is to add to our understanding of opioids and other substance use and suicide risk in Native communities by analyzing individual social network data to understand the relational factors that may increase both risk of suicide and opioid use and the relational characteristics of networks that act as protective factors for suicide and opioid use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Trauma, Psychological, Parenting
Keywords
Native American
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be enrolled in one of two groups; active control or intervention groups. Participants in the control group will participate in group or individual lessons on nutrition every other week over a 12-week period. 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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Little Holy One intervention
Arm Type
Experimental
Arm Description
The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks.
Arm Title
Nutrition control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Active nutrition control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aim 1: Change in caregiver trauma symptoms
Description
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.
Time Frame
Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Title
Aim 1: Change in Caregiver Parenting Stress
Description
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.
Time Frame
Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Aim 1: Change in Caregiver Depression
Description
The CESD-R-10 is comprised of 10 items based on DSM-IV diagnostic criteria for Major Depressive Disorder. Scores range of 0-30, with a score greater than eight indicate clinically significant symptoms. The CESD-R-10 is based on the CESD, a widely validated instrument, including among Native American populations.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Stressful Life Events
Description
The Stressful Life Events Screening Questionnaire (SLESQ) is a 13-item self-report questionnaire designed to assess lifetime exposure to potentially traumatic events. It has been used in several culturally diverse settings and is recommended for use for research purposes.
Time Frame
Baseline visit
Title
Aim 1: Parents' positive childhood experiences
Description
Parents' positive childhood experiences will be measured by self-report at baseline with the Benevolent Childhood Experiences Scale. This is a 10-item scale designed to assess positive childhood experiences in adults with experience of mistreatment or adversity.
Time Frame
Baseline visit
Title
Aim 1: Adverse Childhood Experiences (ACEs)
Description
Parents' ACEs will be measured by self-report at baseline with a 23-item ACEs scale adapted to the study population.
Time Frame
Baseline visit
Title
Aim 1: Parenting practices
Description
Parenting practices will be measured by the Parenting Practices Interview (PPI), a 72-item self-report questionnaire adapted from the Oregon Social Learning Center's Discipline Questionnaire and revised for young children. It measures the disciplinary style of a parent and has been used in a variety of settings and populations.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Parental control
Description
Parental control will be measured by the Parental Locus of Control Scale (PLOC), a 47-item questionnaire which measures five factors to assess the locus of control a parent or caregiver has over a child.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Family routines
Description
Family routines will be measured via self-report using the Family Routines Index, a 28-item questionnaire which measures 10 areas of family routines
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Parent substance use
Description
Parent substance use will be measured via self-report using an adapted version of the 15-item WHO ASSIST Questionnaire, which screens for problematic or risky substance use. A risk score is provided for each of the 10 substances included in the survey. The ASSIST is reliable, valid, flexible, comprehensive, and cross-culturally relevant having been validated with populations all over the world.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Parent historical loss experiences
Description
Parent historical loss experiences will be assessed via self-report at baseline with the Historical Loss Scale. The scale quantifies 12 types of losses that Native American tribes might have experienced in the past, how often they are thought about in the present, and 12 different symptoms that they might have because of thinking about these losses. This scale has been used in previous studies and in several Native American populations.
Time Frame
Baseline visit
Title
Aim 1: Parental communal mastery
Description
Parent communal mastery will be measured via self-report using the 10-item Communal Mastery Scale, which was developed specifically for Native contexts using two commonly employed measures of mastery and self-efficacy and adapted to add more collectivist statements. This scale was successfully used in a previous study at Fort Peck.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Parent tribal identity
Description
Parent tribal identity will be assessed using a modified version of the 6-item Orthogonal Cultural Identification Scale. The scale has been adapted for Assiniboine and Sioux tribal identity and was also used in a previous study on the Fort Peck Reservation.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 1: Parental experiences related to historical trauma
Description
Parents' experiences related to historical trauma will be measured by the Historical Trauma Checklist. This measure is a 15-item checklist, developed from focus group discussions with the Fort Peck Reservation. Three questions are posed to determine relevant historical trauma experiences.
Time Frame
Baseline visit
Title
Aim 2: Parent stress
Description
Parent stress will be measured using the Perceived Stress Scale (PSS). The PSS is a 10-item scale that has been widely used and validated, including in Native American populations.
Time Frame
Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Title
Aim 3: Social networks information
Description
Social networks information will be collected via a 17-item self-report Caregiver Ego Networks Questionnaire. Parents will provide information about tribal affiliation, relationships, substance use, communication, parenting support, and cultural involvement of up to 10 of their closest social relationships.
Time Frame
Baseline visit, 12 weeks, 12 months
Title
Aim 3: Suicide risk
Description
Suicide risk will be measured with six items from the Columbia Suicide Severity Rating Scale (CSSR-S), which has been widely used to identify and assess individuals at risk for suicide across diverse communities and settings.
Time Frame
Baseline visit, 12 weeks, 12 months
Other Pre-specified Outcome Measures:
Title
Aim 1: Secondary outcome of child: child's externalization and internalization of symptoms
Description
The Strengths and Difficulties Questionnaire (SDQ) and impact supplement will measure childrens' externalization and internalization of symptoms via parent report. The SDQ is a 30-item scale which measures 25 attributes on five scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.
Time Frame
Baseline visit, 6 months, 12 months
Title
Aim 1: Secondary outcome of child: head start school attendance
Description
Head Start school attendance will be tracked via teacher report on an ongoing basis for all children enrolled in the study.
Time Frame
Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parent or caregiver of 3-5-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
Exclusion Criteria:
Parent or caregiver is under 18 years of age.
Inability to participate in full intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Brockie, PhD
Phone
410-955-1730
Email
tbrocki1@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ellie Decker, MSPH
Email
edecker5@jhu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Brockie, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Peck Tribal Head Start
City
Poplar
State/Province
Montana
ZIP/Postal Code
59255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriann Ricker, MPH
Phone
406-489-2184
Email
aricker4@jhu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34922510
Citation
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.
Results Reference
derived
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Wakȟáŋyeža (Little Holy One)
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