Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05424679
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-06-15
Brief Title:
Piloting Connection is Medicine The Healing Spirits Program
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Piloting Connection is Medicine The Healing Spirits Program
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess what benefit if any an individualized coping plan and facilitating connections to care through referral coordination in conjunction with culturally tailored caring messages herein called the Connection is Medicine intervention Navajo Nation study name CiMThe Healing Spirits Program White Mountain Apache Tribe Study Name HSP have on the mental health of American Indian AI youth and caregivers who were previously identified as having high levels of anxiety and depression as part of their participation in a cohort study called Project SafeSchools NIH Grant No OT2HD107543
Detailed Description:
The investigators will conduct a Pilot Randomized Controlled Trial RCT among caregivers and youth 11-16 years old who score at elevated risk of anxiety or depression Participants will be recruited from the sample of individuals who have scored at risk on a mental health screening assessment tool in an ongoing cohort study Project SafeSchools NIH Grant No OT2HD107543 All persons who screen at risk will be approached for this pilot study using the studys standardized recruitment script ParentCaregiver participants and youth participants may be enrolled separately All potential study participants will be screened for eligibility after going through the consentassent process This is to confirm that potential participants are still presenting with elevated mental health scores at the start of enrollment For parentcaregiver participants the screening will utilize the same assessments as those used in the Project SafeSchools cohort study All youth participants will complete a version of the brief screening tool as well The screening tool plus a set of additional questions related to the interventions will be administered at 30 days post consent and again at 90 days post consent to all participants These additional assessments are needed to understand the immediate impact of the intervention approaches Additional participant data from the Project SafeSchools study will be analyzed to better understand symptoms prior to the pilot study enrollment and as a longer-term outcome assessment for the pilot study If promising the results of this study will inform a future fully powered study to test these interventions at scale This pilot intervention will utilize a randomized controlled design in which both the intervention and control groups receive individualized coping plans facilitated connections to care and COVID-19 safety messages The intervention group also will receive regular caring messages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None