Clinical trial NCT04201184: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Trauma, Psychological
Parenting
Keywords: Native American
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Annie E. Casey Foundation
First posted: 2019-12-17
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Aim 1: Change in caregiver trauma symptoms
timeFrame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
measure: Aim 1: Change in Caregiver Parenting Stress
timeFrame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Secondary outcomes:
measure: Aim 1: Change in Caregiver Depression
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Stressful Life Events
timeFrame: Baseline visit
measure: Aim 1: Parents' positive childhood experiences
timeFrame: Baseline visit
measure: Aim 1: Adverse Childhood Experiences (ACEs)
timeFrame: Baseline visit
measure: Aim 1: Parenting practices
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Parental control
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Family routines
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Parent substance use
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Parent historical loss experiences
timeFrame: Baseline visit
measure: Aim 1: Parental communal mastery
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Parent tribal identity
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 1: Parental experiences related to historical trauma
timeFrame: Baseline visit
measure: Aim 2: Parent stress
timeFrame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
measure: Aim 3: Social networks information
timeFrame: Baseline visit, 12 weeks, 12 months
measure: Aim 3: Suicide risk
timeFrame: Baseline visit, 12 weeks, 12 months
Other outcomes:
measure: Aim 1: Secondary outcome of child: child's externalization and internalization of symptoms
timeFrame: Baseline visit, 6 months, 12 months
measure: Aim 1: Secondary outcome of child: head start school attendance
timeFrame: Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months
Locations:
city: Poplar
country: United States
facility: Fort Peck Tribal Head Start
state: Montana
Study officials:
affiliation: Johns Hopkins University
name: Teresa Brockie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.