Piloting +Connection is Medicine / The Healing Spirits Program

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Piloting +Connection is Medicine / The Healing Spirits Program

Conditions
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Mental Health Issue, Depressive Symptoms, Anxiety

Intervention / Treatment
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* Behavioral: Safety Planning Intervention
* Behavioral: Caring Contacts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>Behavioral: Caring Contacts<br>* 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.<br>|
| Active Comparator: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group differences in mean scores for caregiver 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. It uses a 0-24 scale, where a score of 13+ is considered high risk. | Baseline-3 months post-baseline; secondary data analysis to measure trends over 12-18 months | 
| 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 scale where a score of 5+ is considered high risk. | Baseline-3 months post-baseline; secondary data analysis to measure trends over 12-18 months | 

Secondary Outcome Measures

| 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 | The CESDR-10 is a revised 10 item self-report questionnaire which measures depressive symptoms in general populations. It utilizes a 0-30 scale, in which a score of 8+ is considered high risk. The CESDR-10 also has one item that asks about recent suicide ideation. | Baseline-3 months post-baseline; secondary data analysis to measure trends over 12-18 months (caregivers only) | 
| Group differences in mean scores for caregiver anxiety over time as assessed by the Patient-Reported Outcome Measurement Information System | 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-3 months post-baseline; secondary data analysis to measure trends over 12-18 months | 
| Group differences in mean scores for youth anxiety over time as assessed by the Screen for Child Anxiety Related Emotional Disorders | 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 scale where a score of 25+ is high risk. | Baseline-3 months post-baseline; secondary data analysis to measure trends over 12-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Indians and Alaska Natives, COVID-19, Safety Planning Intervention, Mental Health