Adverse Childhood ExperiencesJOHANCT04096937
Journey of Hope in Appalachia: Supporting Resilience in the Region's Youth
An observational study of Adverse Childhood Experiences, run by Gia Mudd at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences
- What is being tested?
- Focus groups
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2021to 22 Mar 2022
- Phase
- Observational
- 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 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Youth or adults who are residents of Appalachia
- Able to read and speak in English
Who cannot join
- Youth or adults who are not residents of Appalachia Kentucky or West Virginia
- Children under the age of 10
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky, Center of Excellence in Rural Health
Hazard, Kentucky, 40536-0232
West Virginia University
Morgantown, West Virginia, 26506
About this study
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.
- Conditions
- Adverse Childhood Experiences
- Being tested
- Focus groups
- Keywords
- Resilience, Appalachian youth, Community-based participatory research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Appalachian adults | Adults in Appalachia invested in well-being of youth. Receives: Other: Focus groups | |
| Appalachian youth | Youth from 7th through 12th grade. Receives: Other: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 May 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Mudd
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University
- Responsible party
- Sponsor-investigator, Gia Mudd, University of Kentucky
- Investigators
- Gia Mudd-Martin, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096937
- Sponsor's protocol ID
- 46776
- Acronym
- JOHA
- Status last verified
- Nov 2022
- First submitted
- 18 Sep 2019
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Journey of Hope in Appalachia: Supporting Resilience in the Region's Youth
- ClinicalTrials.gov ID
- NCT04096937
- Acronym / sponsor ID
- JOHA / 46776
- Conditions
- Adverse Childhood Experiences
- Keywords
- Resilience, Appalachian youth, Community-based participatory research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gia MuddUniversity, hospital or other
- Collaborators
- West Virginia University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 20 Sep 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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appalachian adults | – | Other: Focus groupsAdults in Appalachia invested in well-being of youth. |
| Appalachian youth | – | Other: Focus groupsYouth from 7th through 12th grade. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Youth or adults who are residents of Appalachia
- Able to read and speak in English
Key exclusion criteria (2 listed)
- Youth or adults who are not residents of Appalachia Kentucky or West Virginia
- Children under the age of 10
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 |
|---|---|---|
| Focus groupsFocus 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. | Other | Appalachian adults, Appalachian youth |
Primary outcome
Number of themes
Time frame: 6 months
Number of themes that emerge from the focus group data useful for guiding cultural tailoring of the Journey of Hope in Appalachia intervention.
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 25 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Adverse Childhood Experiences
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A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
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Resilient Students Training (ReST) : A Pilot RCT
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EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
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EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
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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.
Gia Mudd-Martin, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Childhood Experiences, run by Gia Mudd at 2 sites 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 2 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 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of themes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2022.