Piloting +Connection is Medicine / The Healing Spirits Program

NCT05424679 | Completed Results

• 2 other identifiers: IRB00020570OT2HD107543
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

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; +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).

Conditions

Mental Health Issue; Depressive Symptoms; Anxiety

Keywords

American Indians and Alaska Natives; COVID-19; Safety Planning Intervention; Mental Health

Outcome Measures

Primary Outcomes (2)

• Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale

  The Kessler Psychological Distress Scale is a six item self-report questionnaire that gathers information about a person's psychological distress. 0-24 score range where a score of 13+ is considered high risk.

  Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

• Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire

  The SDQ is a self-report questionnaire that can be used with youth ages 11-17. The emotional symptoms subscale is used in the questionnaire, which consists of 5 items. The questionnaire uses a 0-10 score range where a score of 5+ is considered high risk.

  Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

Secondary Outcomes (3)

• 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 (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

• Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System

  Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

• Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders

  Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

Other Outcomes (7)

• 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

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

• 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

  Baseline-3-months post-baseline

• Group Differences in Mean Scores for Youth Resilience Over Time as Assessed by Two Items From the Child/Youth Resilience Scale

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Safety Planning Intervention; Behavioral: Caring Contacts

Control group

ACTIVE COMPARATOR

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.

Behavioral: Safety Planning Intervention

Interventions

Safety Planning Intervention BEHAVIORAL

The Safety Planning Intervention is a brief intervention that directly targets suicide risk with demonstrated efficacy and is a recommended best practice for suicide prevention. The intervention aims to provide participants with an individualized set of steps that can be used progressively to both reduce risk and maintain safety when under particular stress. It also includes a series of brief telephone calls to revise the safety plan and facilitate connections to care. The study team will adapt the intervention to target a larger range of mental health distress.

Control group; Intervention group

Caring Contacts BEHAVIORAL

Caring contacts is a cost and time effective suicide prevention intervention. It traditionally utilizes letters and postcards that are sent to an individual to remind them that they are cared about and that they matter. Research suggests that this intervention significantly reduces the likelihood of dying by suicide and suicide attempt over a person's lifetime. This intervention has the potential to reach more individuals at risk in the community. In this study, the research team will allow participants to receive these messages by postcard/MMS and will adapt the intervention to align with cultural values.

Intervention group

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• Adult Participants
• General Distress (Kessler)
• Anxiety (PROMIS)
• Depression (CESDR-10)
• Recent Suicide Ideation (either CESDR-10 or Ideation Questionnaire)
• Youth Participants:

You may not qualify if:

• Inability to cognitively complete interventions and assessments

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institutes of Health Clinical Center (CC): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Johns Hopkins Center for American Indian Health - Chinle Site

Chinle, Arizona, 86503, United States

Location

Johns Hopkins Center for American Indian Health - Tuba City Site

Tuba City, Arizona, 86045, United States

Location

Johns Hopkins Center for American Indian Health - Whiteriver Site

Whiteriver, Arizona, 85941, United States

Location

Johns Hopkins Center for American Indian Health - Shiprock Site

Shiprock, New Mexico, 87420, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction

Results Point of Contact

• Title: Dr. Emily Haroz
• Organization: Johns Hopkins Center for Indigenous Health

eharoz1@jhu.edu

(410) 449-0051

Study Officials

• Emily Haroz, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot intervention trial will utilize a randomized controlled design with 1:1 allocation to either the intervention or control group. Both intervention and control groups will receive individualized coping plans, facilitated connections to care, and COVID-19 safety messages. The intervention group will receive caring messages sent on a standardized schedule in addition to what the control group receives.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: August 24, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)