Clinical trial NCT05424679: Piloting +Connection is Medicine / The Healing Spirits Program
Official title: Piloting +Connection is Medicine / The Healing Spirits Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Depressive Symptoms
Anxiety
Keywords: American Indians and Alaska Natives
COVID-19
Safety Planning Intervention
Mental Health
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health Clinical Center (CC)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-06-21
Enrollment: 74
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale
timeFrame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
measure: Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire
timeFrame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
Secondary outcomes:
measure: 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
timeFrame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
measure: Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System
timeFrame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
measure: Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders
timeFrame: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
Other outcomes:
measure: 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
timeFrame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
measure: 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
timeFrame: Baseline-3-months post-baseline
measure: Group Differences in Mean Scores for Youth Resilience Over Time as Assessed by Two Items From the Child/Youth Resilience Scale
timeFrame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
measure: Group Differences in Youth Self-harm Scored as Individual Indicator Variables on Two Internally Developed Items
timeFrame: Baseline-3-months post-baseline; secondary data analysis to measure trends over 12-18 months
measure: Group Differences in Means Scores for Youth Knowledge of Coping Strategies as Assessed by One Internally Developed Item
timeFrame: Baseline-3-months post-baseline
measure: Group Differences in Caregiver and Youth Mental Health Service Knowledge, Access, and Use Scored as Individual Indicator Variables on an Internally Developed Questionnaire
timeFrame: Baseline-3-months post-baseline
measure: Group Differences in Average Scores for Caregiver and Youth COVID-19 Behaviors and Attitudes as Assessed by an Internally Developed Questionnaire
timeFrame: Baseline-3-months post-baseline
Locations:
city: Chinle
country: United States
facility: Johns Hopkins Center for American Indian Health - Chinle Site
state: Arizona
city: Tuba City
country: United States
facility: Johns Hopkins Center for American Indian Health - Tuba City Site
state: Arizona
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health - Whiteriver Site
state: Arizona
city: Shiprock
country: United States
facility: Johns Hopkins Center for American Indian Health - Shiprock Site
state: New Mexico
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Emily Haroz, PhD
role: PRINCIPAL_INVESTIGATOR
References: