Safety Planning Intervention for Mental Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins Center for American Indian Health - Chinle Site, Chinle, AZ
Mental Depression+3 More
Safety Planning Intervention - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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; +CiM)/The 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).

Eligible Conditions

  • Mental Health Issue
  • Mental Depression
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months

Month 18
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 caregiver general distress over time as assessed by the Kessler Psychological Distress Scale
Group differences in mean scores for youth anxiety over time as assessed by the Screen for Child Anxiety Related Emotional Disorders
Group differences in mean scores for youth emotional problems over time as assessed by the Strengths and Difficulties Questionnaire
Month 18
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
Baseline-3-months post-baseline
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
Group differences in means scores for youth knowledge of coping strategies as assessed by one internally developed item
Participant characterization of intervention implementation and feedback scored as individual indicator variables on an internally developed questionnaire
Month 18
Group differences in mean scores for caregiver social connectedness over time as assessed by a subset of questions from Awareness of Connectedness and Multicultural Mastery Scale
Group differences in mean scores for caregiver social connectedness over time as assessed by a subset of questions that measure connection to others and several from the Communal Mastery scale
Group differences in mean scores for youth resilience over time as assessed by two items from the Child/Youth Resilience Scale
Group differences in youth self-harm scored as individual indicator variables on two internally developed items

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control group
1 of 2
Intervention group
1 of 2
Active Control
Experimental Treatment

144 Total Participants · 2 Treatment Groups

Primary Treatment: Safety Planning Intervention · No Placebo Group · N/A

Intervention groupExperimental Group · 2 Interventions: Caring Contacts, Safety Planning Intervention · Intervention Types: Behavioral, Behavioral
Control group
Behavioral
ActiveComparator Group · 1 Intervention: Safety Planning Intervention · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caring Contacts
2020
N/A
~110
Safety Planning Intervention
2017
N/A
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Closest Location: Johns Hopkins Center for American Indian Health - Chinle Site · Chinle, AZ
Photo of arizona 1Photo of arizona 2Photo of arizona 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Mental Depression
0 CompletedClinical Trials

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
358 Previous Clinical Trials
2,055,201 Total Patients Enrolled
Emily Haroz, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
2 Previous Clinical Trials
166 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are an adult.
You meet symptom eligibility criteria at a screening assessment/baseline visit indicating mental distress.
You are a parent/caregiver or index youth aged 18 years or older.
You are an adult.
You have elevated levels of mental distress as reported in a Project SafeSchools assessment.
You meet the symptom eligibility criteria based on a self-report screening assessment/baseline visit indicating mental distress.
You have a general distress.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.