Mental Health IssueNCT05424679

Piloting +Connection is Medicine / The Healing Spirits Program

A study testing Safety Planning Intervention and Caring Contacts in people with Mental Health Issue and Depressive Symptoms, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for: Mental Health Issue, Depressive Symptoms, Anxiety
What is being tested?: Safety Planning Intervention and Caring Contacts
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 4 sitesUnited States
Study dates: 24 Aug 2022to 30 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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:

Show all 20Show fewer

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)

Who cannot join

Inability to cognitively complete interventions and assessments

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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).

Read the 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.

Conditions: Mental Health Issue, Depressive Symptoms, Anxiety
Being tested: Safety Planning Intervention, Caring Contacts
Keywords: American Indians and Alaska Natives, COVID-19, Safety Planning Intervention, Mental Health
Medical subject headings: Depression, Anxiety Disorders, COVID-19, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Safety Planning InterventionBehavioural
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.
Caring ContactsBehavioural
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.

Study groups in NCT05424679
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Safety Planning Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202230 Jun 2023

First posted21 Jun 2022
Study start24 Aug 2022
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mental Health IssueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05424679
Sponsor's protocol ID: IRB00020570
Other IDs: OT2HD107543
Status last verified: Aug 2024
First submitted: 15 Jun 2022
Last updated: 3 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: INSERT

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mental Health Issue trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Piloting +Connection is Medicine / The Healing Spirits Program
ClinicalTrials.gov ID: NCT05424679
Acronym / sponsor ID: IRB00020570
Conditions: Mental Health Issue, Depressive Symptoms, Anxiety
Keywords: American Indians and Alaska Natives, COVID-19, Safety Planning Intervention, Mental Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: National Institutes of Health Clinical Center (CC), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 24 Aug 2022 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 21 Jun 2022 (actual)
Results: Posted 3 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Safety Planning Intervention, Behavioral: Caring ContactsIndividuals 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.
Control group	Active comparator	Behavioral: Safety Planning InterventionIndividuals 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.

Who may qualify

Ages: 11 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

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.

Key exclusion criteria (1 listed)

Inability to cognitively complete interventions and assessments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Safety Planning InterventionThe 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.	Behavioural	Control group, Intervention group
Caring ContactsCaring 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.	Behavioural	Intervention group

Primary outcome

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.
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.

3 secondary outcomes

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)
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)
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)

Results and safety

Results posted to the registry on 3 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	38	21
Control Group	36	27

Primary outcome: 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). Mean (Standard Deviation). Unit: score on scale

Measure	Intervention Group n = 38	Control Group n = 36
Baseline	8.56 (3.84)	8.69 (4.42)
Midline	6.52 (4.55)	8.0 (4.67)
End-line	6.33 (5.88)	7.19 (4.38)

Population analysed: Includes youth and adult participants.

Primary outcome: 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). Mean (Standard Deviation). Unit: score on scale

Measure	Intervention Group n = 5	Control Group n = 4
Baseline	5.75 (0.96)	5.0 (2.65)
Midline	1.67 (1.15)	4.33 (2.52)
End-line	3.0 (1.41)	4.5 (4.95)

Population analysed: Youth only. Two adult children are included in analysis (i.e., older than 18), which reflects the Participant Flow numbers but differs from the Baseline Characteristics numbers. One adult child is in each group.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected between baseline and end-line, a 9-month period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Control Group	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. INSERT

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily Haroz, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.