SuicideNCT04201184
Wakȟáŋyeža (Little Holy One)
A study testing Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules in people with Suicide and Trauma, Psychological, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Trauma, Psychological, Parenting
- What is being tested?
- Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Parent or caregiver is under 18 years of age.
- Inability to participate in full intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wakȟáŋyeža (Little Holy One): Enhancing Caregivers' and Children's Well-being Through an Evidence-based and Culturally Informed Prevention Intervention
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.
Read the 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 2 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.
- Conditions
- Suicide, Trauma, Psychological, Parenting
- Being tested
- Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules, Active nutrition control
- Keywords
- Native American
- Medical subject headings
- Suicide, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly created cultural components, adapted Family Spirit lessons, adapted CETA modulesBehavioural
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
Active nutrition controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Little Holy One intervention | Experimental | The participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks. Receives: 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. Receives: Behavioral: Active nutrition control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Secondary outcomes (15)
Aim 1: Change in Caregiver Depression
The Center for Epidemiologic Studies Depression Scale (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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit
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.
Measured: Baseline visit
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.
Measured: Baseline visit
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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit, 12 weeks, 12 months
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
Measured: Baseline visit, 12 weeks, 12 months
Aim 1: Parent substance use
Parent substance use will be measured via self-report using an adapted version of the 15-item World Health Organization (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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit
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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit
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.
Measured: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
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.
Measured: Baseline visit, 12 weeks, 12 months
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.
Measured: Baseline visit, 12 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start18 Nov 2019
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Annie E. Casey Foundation
- Responsible party
- Sponsor
- Investigators
- Teresa Brockie, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201184
- Sponsor's protocol ID
- IRB00200073
- Other IDs
- 1R01MH115840-01A1
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2019
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34922510Wilson 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.
PubMed 36644672
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wakȟáŋyeža (Little Holy One): Enhancing Caregivers' and Children's Well-being Through an Evidence-based and Culturally Informed Prevention Intervention
- ClinicalTrials.gov ID
- NCT04201184
- Acronym / sponsor ID
- IRB00200073
- Conditions
- Suicide, Trauma, Psychological, Parenting
- Keywords
- Native American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Annie E. Casey Foundation
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 2 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Little Holy One intervention | Experimental | Behavioral: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modulesThe participants will receive 12 1-hour lessons on parenting, stress, and culture over a period of 16 weeks. |
| Nutrition control | Active comparator | Behavioral: Active nutrition controlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Parent or caregiver is under 18 years of age.
- Inability to participate in full intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newly created cultural components, adapted Family Spirit lessons, adapted CETA modulesCaregivers 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 | Behavioural | Little Holy One intervention |
| Active nutrition controlThe 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. | Behavioural | Nutrition control |
Primary outcome
Aim 1: Change in caregiver trauma symptoms
Time frame: Baseline visit, 6 weeks, 12 weeks, 6 months, 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.
Aim 1: Change in Caregiver Parenting Stress
Time frame: Baseline visit, 6 weeks, 12 weeks, 6 months, 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.
15 secondary outcomes
Aim 1: Change in Caregiver Depression
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Stressful Life Events
Time frame: Baseline visit
Aim 1: Parents' positive childhood experiences
Time frame: Baseline visit
Aim 1: Adverse Childhood Experiences (ACEs)
Time frame: Baseline visit
Aim 1: Parenting practices
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Parental control
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Family routines
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Parent substance use
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Parent historical loss experiences
Time frame: Baseline visit
Aim 1: Parental communal mastery
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Parent tribal identity
Time frame: Baseline visit, 12 weeks, 12 months
Aim 1: Parental experiences related to historical trauma
Time frame: Baseline visit
Aim 2: Parent stress
Time frame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Aim 3: Social networks information
Time frame: Baseline visit, 12 weeks, 12 months
Aim 3: Suicide risk
Time frame: Baseline visit, 12 weeks, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 34922510Brockie 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.
- Derived from this study: PubMed 36644672Wilson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Brockie, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules in people with Suicide and Trauma, Psychological, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Change in caregiver trauma symptoms (time frame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04201184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.