Trial Outcomes & Findings for Piloting +Connection is Medicine / The Healing Spirits Program (NCT NCT05424679)

NCT ID: NCT05424679

Last Updated: 2024-09-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: Baseline (0 months); Midline (1 month post-baseline); End-line (3 months post-Baseline)
• Results posted on: 2024-09-03

Participant Flow

Participant milestones

Measure	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. 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. It is the same as the Control group. 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.	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. 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.
Overall Study STARTED	38	36
Overall Study Youth Participants	5	4
Overall Study Adult Participants	33	32
Overall Study COMPLETED	21	27
Overall Study NOT COMPLETED	17	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Piloting +Connection is Medicine / The Healing Spirits Program

Baseline characteristics by cohort

Measure	Intervention Group n=38 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=36 Participants 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. 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.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	35.8 years STANDARD_DEVIATION 12.4 • n=5 Participants	35.6 years STANDARD_DEVIATION 10.1 • n=7 Participants	35.7 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Native American or American Indian	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Other Indigenous Ancenstry	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiple Races	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized No Race Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants	36 Participants n=7 Participants	74 Participants n=5 Participants
Distress	8.56 units on a scale STANDARD_DEVIATION 3.84 • n=5 Participants	8.69 units on a scale STANDARD_DEVIATION 4.42 • n=7 Participants	8.62 units on a scale STANDARD_DEVIATION 4.10 • n=5 Participants

PRIMARY outcome

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

Population: Includes youth and adult participants.

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.

Outcome measures

Measure	Intervention Group n=38 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=36 Participants 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. 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.
Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale Baseline	8.56 score on scale Standard Deviation 3.84	8.69 score on scale Standard Deviation 4.42
Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale Midline	6.52 score on scale Standard Deviation 4.55	8.0 score on scale Standard Deviation 4.67
Group Differences in Mean Scores for Caregiver and Youth General Distress Over Time as Assessed by the Kessler Psychological Distress Scale End-line	6.33 score on scale Standard Deviation 5.88	7.19 score on scale Standard Deviation 4.38

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Intervention Group n=5 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=4 Participants 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. 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.
Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire Baseline	5.75 score on scale Standard Deviation 0.96	5.0 score on scale Standard Deviation 2.65
Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire Midline	1.67 score on scale Standard Deviation 1.15	4.33 score on scale Standard Deviation 2.52
Group Differences in Mean Scores for Youth Emotional Problems Over Time as Assessed by the Strengths and Difficulties Questionnaire End-line	3.0 score on scale Standard Deviation 1.41	4.5 score on scale Standard Deviation 4.95

SECONDARY outcome

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

Population: Adult + Youth

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.

Outcome measures

Measure	Intervention Group n=38 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=36 Participants 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. 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.
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 Baseline	10.9 score on scale Standard Deviation 4.97	12.8 score on scale Standard Deviation 6.01
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 Midline	7.36 score on scale Standard Deviation 5.92	10.4 score on scale Standard Deviation 5.66
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 End-line	6.62 score on scale Standard Deviation 4.75	9.74 score on scale Standard Deviation 6.54

SECONDARY outcome

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

Population: Adult caregivers only. The number of participants analyzed here matches the Participant Flow but differs from the Baseline Characteristics. The Baseline Characteristics age disaggregations include two adult children who our study considers as 'youth'. Therefore, the number reported here excludes these adult children.

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.

Outcome measures

Measure	Intervention Group n=33 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=32 Participants 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. 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.
Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System Midline	16.7 score on scale Standard Deviation 7.92	18.3 score on scale Standard Deviation 6.51
Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System Baseline	20.5 score on scale Standard Deviation 5.32	20.6 score on scale Standard Deviation 4.94
Group Differences in Mean Scores for Caregiver Anxiety Over Time as Assessed by the Patient-Reported Outcome Measurement Information System End-line	14.9 score on scale Standard Deviation 6.69	15.8 score on scale Standard Deviation 6.19

SECONDARY outcome

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

Population: Youth only. The number of participants analyzed matches the Participant Flow but differs from the Baseline Characteristics. Our study considered 'youth' to be children of parents from another study, regardless of age. Therefore, there are two adult children included in the Baseline Characteristics that we consider 'youth' and are reporting as such. One adult child is included in each intervention arm reported here.

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.

Outcome measures

Measure	Intervention Group n=5 Participants 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. 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. It is the same as the Control group. 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.	Control Group n=4 Participants 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. 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.
Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders End-line	12.5 score on scale Standard Deviation 13.4	20.0 score on scale Standard Deviation 5.66
Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders Baseline	23.8 score on scale Standard Deviation 8.62	26.7 score on scale Standard Deviation 8.33
Group Differences in Mean Scores for Youth Anxiety Over Time as Assessed by the Screen for Child Anxiety Related Emotional Disorders Midline	9.0 score on scale Standard Deviation 5.0	23.3 score on scale Standard Deviation 19.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emily Haroz

Johns Hopkins Center for Indigenous Health

Phone: (410) 449-0051

Email: eharoz1@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place