Piloting +Connection is Medicine / The Healing Spirits Program

August 29, 2024 updated by: Johns Hopkins Bloomberg School of Public Health
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 study's standardized recruitment script. Parent/Caregiver participants and youth participants may be enrolled separately. All potential study participants will be screened for eligibility after going through the consent/assent process. This is to confirm that potential participants are still presenting with elevated mental health scores at the start of enrollment. For parent/caregiver 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chinle, Arizona, United States, 86503
        • Johns Hopkins Center for American Indian Health - Chinle Site
      • Tuba City, Arizona, United States, 86045
        • Johns Hopkins Center for American Indian Health - Tuba City Site
      • Whiteriver, Arizona, United States, 85941
        • Johns Hopkins Center for American Indian Health - Whiteriver Site
    • New Mexico
      • Shiprock, New Mexico, United States, 87420
        • Johns Hopkins Center for American Indian Health - Shiprock Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 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 Criteria:

  • Inability to cognitively complete interventions and assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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
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.
Behavioral: Caring Contacts
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.
Active Comparator: Control group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale
Time Frame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
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
Time Frame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
The CESDR-10 is a revised 10 item self-report questionnaire which measures depressive symptoms in general populations. It utilizes a 0-30 score range, in which a score of 8+ is considered high risk. The CESDR-10 also has one item that asks about recent suicide ideation.
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
Time Frame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
PROMIS is an eight-statement survey that measures emotional distress due to anxiety that has been experienced over the previous seven days. It uses a five-point Likert scale, 1 indicating 'never' to 5 indicating 'always'. The survey is scored from 8-40 with a score of 17+ indicating high risk.
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
Time Frame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
The SCARED survey can be used with those aged 8-18 years. It includes 41 items and five scales which measure somatic/panic, general anxiety, separation anxiety, social phobia, and school phobia. SCARED uses a 0-82 score range where a score of 25+ is high risk.
Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Investigators developed 4 items that measure connection to peers and family for use in the study. The Communal Mastery scale measures problem solving through the participant's community and social network. Three items from the Communal Mastery scale relevant to the intervention are included. All seven items are scored on a four-point Likert-type scale, with total possible range from 7-28. Higher scores represent higher levels of connectedness.
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
Time Frame: Baseline-3-months post-baseline
8 items out of 28 items in the brief COPE that are relevant to the intervention, focusing on coping behaviors that could be modified through the coping plan. Items are answered on a Likert-type scale. For this study, scores can range from 8 to 32 with higher scores representing higher levels of coping behavior.
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
Time Frame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Two items related to social connections from the Child/Youth Resilience Scale were selected to assess youth resilience. Each question is rated on a scale of 1-5, for an overall scale score of 2-10. Higher scores represent a better outcome of more youth resilience.
Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Group Differences in Youth Self-harm Scored as Individual Indicator Variables on Two Internally Developed Items
Time Frame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Two items related to self-harm that were internally developed by the study team. The first item is answered yes or no. The second item asks about recency if the first item is yes. These items will be treated as indicator variables and will not be scored as a scale.
Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
Group Differences in Means Scores for Youth Knowledge of Coping Strategies as Assessed by One Internally Developed Item
Time Frame: Baseline-3-months post-baseline
One item related to knowledge of coping strategies was internally developed by the study team. Items are scored using a Likert-type scale, with 0 indicating strong disagreement with a statement and 5 indicating strong agreement with a statement. Higher scores on this item will indicate more knowledge of coping strategies.
Baseline-3-months post-baseline
Group Differences in Caregiver and Youth Mental Health Service Knowledge, Access, and Use Scored as Individual Indicator Variables on an Internally Developed Questionnaire
Time Frame: Baseline-3-months post-baseline
This is an internally developed questionnaire that includes 1 item on knowledge of mental health services in the community, 1 item on accessibility of mental health resources, 1 item on use of services in the previous 30 days, and 1 item on difficulties accessing services in the previous 30 days. The items on knowledge of services and accessibility of services are scored using a Likert-type scale, with 0 indicating strong disagreement with the statement and 5 indicating strong agreement with the statement. Items will be scored separately, with higher scores on each item indicating greater knowledge or accessibility. The two items on services use in the previous 30 days and difficulties accessing services in the previous 30 days use a single dichotomous answer (yes or no). These items will be analyzed separately with a dichotomous variable with yes representing service use or difficulties with service use in the past 30 days.
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
Time Frame: Baseline-3-months post-baseline
This is an internally developed, 7-item inventory on participants' attitudes towards specific COVID-19 related behaviors, including masking, testing, and vaccinations. Scale scores range from 0-28, with higher score representing more positive attitudes towards COVID-19 prevention behaviors and attitudes.
Baseline-3-months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health Clinical Center (CC)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily Haroz, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00020570
  • OT2HD107543 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

INSERT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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