Piloting +Connection is Medicine / The Healing Spirits Program

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Depressive Symptoms; Mental Health Issue; Anxiety

Treatments: Behavioral: Safety Planning Intervention; Behavioral: Caring Contacts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05424679

OT2HD107543 (U.S. NIH Grant/Contract)

IRB00020570

Details and patient eligibility

About

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).

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 11+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Caring Contacts

Behavioral: Safety Planning Intervention

Control group

Active Comparator group

Description:

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:

Behavioral: Safety Planning Intervention