NCT04096937

Brief Summary

Rural youth have heightened exposure to adverse childhood experiences (ACES) such as poverty, social isolation, chronic hunger, and drug use in the home. These threats can lead to downstream problems with emotion regulation, substance abuse, and heightened vulnerability to chronic disease. Resilience is the capacity to adapt positively in the face of such disadvantage. Youth resilience interventions can buffer the negative effects of ACES. Unfortunately, rural schools and other youth-serving agencies often have inadequate capacity to provide such interventions. Thus, there is a critical need to develop cost-effective, sustainable, and culturally-relevant youth resilience interventions that can be delivered by trained personnel with dedicated time and resources. WVU, UK, and Save The Children have a long-term goal to establish a sustained community-engaged research partnership to promote resilience in Appalachian youth. This is a community-based participatory research (CBPR)-guided study being conducted for the purpose of developing a culturally relevant, intervention to promote Appalachian youth resilience. The intervention, called Journey of Hope in Appalachia (JOHA), has as it's starting point Save The Children's evidence-based Journey of Hope (JOH) program that targets youth experiencing acute stress from natural disasters and similar events. This program will be culturally adapted to promote resilience among Appalachian youth experiencing ACES. JOHA will incorporate positive aspects of Appalachian culture (e.g., storytelling, theater, music) and will be designed for sustainability and eventual dissemination by Save through the Appalachian Translational Research Network (ATRN) and other regional Networks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

September 18, 2019

Last Update Submit

November 23, 2022

Conditions

Keywords

ResilienceAppalachian youthCommunity-based participatory research

Outcome Measures

Primary Outcomes (1)

  • Number of themes

    Number of themes that emerge from the focus group data useful for guiding cultural tailoring of the Journey of Hope in Appalachia intervention.

    6 months

Study Arms (2)

Appalachian adults

Adults in Appalachia invested in well-being of youth.

Other: Focus groups

Appalachian youth

Youth from 7th through 12th grade.

Other: Focus groups

Interventions

Focus groups will be conducted with adult stakeholders and with youth in Appalachia. Feedback from the focus groups will guide cultural tailoring of the Journey of Hope in Appalachia intervention for use in a later phase.

Appalachian adultsAppalachian youth

Eligibility Criteria

Age10 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Youth of Appalachia Kentucky and West Virginia and adults who are parents of youth or are stakeholders in the health and well-being of Appalachian youth.

You may qualify if:

  • Youth or adults who are residents of Appalachia
  • Able to read and speak in English

You may not qualify if:

  • Youth or adults who are not residents of Appalachia Kentucky or West Virginia
  • Children under the age of 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky, Center of Excellence in Rural Health

Hazard, Kentucky, 40536-0232, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gia Mudd-Martin, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

May 1, 2021

Primary Completion

March 22, 2022

Study Completion

March 22, 2022

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations