Status:
COMPLETED
Piloting +Connection is Medicine / The Healing Spirits Program
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institutes of Health Clinical Center (CC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Mental Health Issue
Depressive Symptoms
Eligibility:
All Genders
11+ years
Phase:
NA
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...
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 recruite...
Eligibility Criteria
Inclusion
- \- All participants must be parents/caregivers or index youth enrolled in a cohort study called Project SafeSchools.
- Adult participants
- Have elevated levels of mental distress as reported in a Project SafeSchools assessment.
- Agreement to be re-contacted for future research as part of their Project SafeSchools consent.
- Meeting symptom eligibility criteria at a screening assessment/baseline visit indicating mental distress.
- Youth participants:
- Are 11-16 years old
- Agreement from parent/caregiver to be re-contacted for future research from their Project SafeSchools consent form.
- Meeting symptom eligibility criteria based on a self-report screening assessment/baseline visit indicating mental distress.
- For the inclusion criteria, mental distress is defined as meeting eligibility cutoff scores on the following instruments:
- Adult Participants
- General Distress (Kessler)
- Anxiety (PROMIS)
- Depression (CESDR-10)
- Recent Suicide Ideation (either CESDR-10 or Ideation Questionnaire)
- Youth Participants:
- Depression (CESDR-10)
- Emotional Problems (SDQ Emotional Problems Subscale)
- Anxiety (SCARED)
- Recent Ideation (Ideation question on CESDR-10 or ideation questionnaire)
Exclusion
- Inability to cognitively complete interventions and assessments
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05424679
Start Date
August 24 2022
End Date
June 30 2023
Last Update
September 3 2024
Active Locations (4)
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1
Johns Hopkins Center for American Indian Health - Chinle Site
Chinle, Arizona, United States, 86503
2
Johns Hopkins Center for American Indian Health - Tuba City Site
Tuba City, Arizona, United States, 86045
3
Johns Hopkins Center for American Indian Health - Whiteriver Site
Whiteriver, Arizona, United States, 85941
4
Johns Hopkins Center for American Indian Health - Shiprock Site
Shiprock, New Mexico, United States, 87420