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Safety Planning Intervention for Mental Health Issue

N/A

Waitlist Available

Led By Emily Haroz, PhD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline-3 months post-baseline; secondary data analysis to measure trends over 12-18 months

Awards & highlights

Study Summary

This trial will study the effects of a personalized coping plan and culturally-tailored care messages on the mental health of American Indian youth and caregivers who have previously been identified as having high levels of anxiety and depression.

Eligible Conditions

Mental Health Issue
Anxiety
Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Group differences in mean scores for caregiver general distress over time as assessed by the Kessler Psychological Distress Scale

Group differences in mean scores for youth emotional problems over time as assessed by the Strengths and Difficulties Questionnaire

Secondary outcome measures

Group differences in mean scores for caregiver and youth depressive symptoms over time as assessed by the Center for Epidemiologic Studies Depression Scale-Revised-10

Group differences in mean scores for caregiver anxiety over time as assessed by the Patient-Reported Outcome Measurement Information System

Group differences in mean scores for youth anxiety over time as assessed by the Screen for Child Anxiety Related Emotional Disorders

Other outcome measures

Group differences in average scores for caregiver and youth COVID-19 behaviors and attitudes as assessed by an internally developed questionnaire

Group differences in caregiver and youth mental health service knowledge, access, and use scored as individual indicator variables on an internally developed questionnaire

Group differences in mean scores for caregiver and youth coping behaviors over time as assessed by a subset of questions from the Brief COPE Inventory

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment2 Interventions

Individuals randomized to the intervention group will receive an evidence-based tool (coping plan + two additional check-in calls or visits), up to three COVID-19 safety messages, information on and facilitated referrals to community support services (e.g., tribal behavioral health), and up to seven culturally responsive caring messages (i.e. Caring Contacts) from the research team over a period of three months.

Group II: Control groupActive Control1 Intervention

Individuals randomized to the control group will receive an evidence-based tool (coping plan + two additional check-in calls or visits), up to three COVID-19 safety messages, and information on and facilitated referrals to community support services (e.g., tribal behavioral health) from the research team over a period of three months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Safety Planning Intervention

2017

N/A

~570

Caring Contacts

2020

N/A

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor

410 Previous Clinical Trials

2,116,786 Total Patients Enrolled

1 Trials studying Mental Health Issue

188 Patients Enrolled for Mental Health Issue

Emily Haroz, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

2 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ceiling for participant enrollment in this experiment?

"Indeed, the information on clinicaltrials.gov verifies that this study is seeking participants. Initially posted on August 24th 2022, it was recently updated on August 26th and they are accepting 144 individuals from 4 separate locations to take part in this trial."

Answered by AI

Are there any available slots for individuals seeking to join this experiment?

"Confirmed. Records from clinicaltrials.gov demonstrate that this medical research, which began enlisting participants on the 24th of August 2022, is actively seeking volunteers. A total of 144 people need to be recruited from 4 separate facilities."

Answered by AI

What are the locations where this scientific exploration is being conducted?

"As of now, there are 4 clinical sites offering this trial. These medical centres can be found in Tuba City, Shiprock and Whiteriver as well as other nearby locations. Consequently, it is advised to pick the closest facility to minimise travel requirements if you choose to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Piloting +Connection is Medicine / The Healing Spirits Program

Emily Haroz 2022. "Piloting +Connection is Medicine / The Healing Spirits Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424679.