SuicideNCT03655119
PES Family Support and Follow-Up Program
A study testing Parent toolkit, Enhanced Care and Caring Follow-Up Messages in people with Suicide, run by University of Michigan at 1 site in United States.
Trial summary
The Psychiatric Emergency Services (PES) Family Support and Follow-Up Program is a service delivery intervention that utilizes a multi-component approach to enhance usual care provided to youth and families at the University of Michigan Psychiatric Emergency Services in order to promote youth safety and provide… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Suicide
- What is being tested?
- Parent toolkit, Enhanced Care and Caring Follow-Up Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting to U-M Psychiatric Emergency Services
- Experiencing suicide-related concerns
Who cannot join
- Do not speak English
- Currently experiencing psychosis
- Currently intoxicated
- Cognitively impaired
- Currently experiencing severe aggression or agitation
- Unaccompanied by parent/legal guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Psychiatric Emergency Services
Ann Arbor, Michigan, 48109
About this study
Official title: Psychiatric Emergency Services Family Support and Follow-Up Program
The Psychiatric Emergency Services (PES) Family Support and Follow-Up Program is a service delivery intervention that utilizes a multi-component approach to enhance usual care provided to youth and families at the University of Michigan Psychiatric Emergency Services in order to promote youth safety and provide support to families following their visit. During the first phase of intervention, families will receive enhanced usual care by clinical staff along with a family toolkit that includes a youth safety plan and written recommendations for safety monitoring and supporting youth during a crisis. During the second phase of intervention, families will receive the interventions provided during the first phase in addition to caring contacts post discharge, which may occur by phone, text, or email. Caring contacts are meant to provide support, additional education, and problem solving assistance.
Read the detailed description
All participants complete a battery of measures in the waiting room during their PES visit. Youth will complete surveys that collect demographic information, assess current suicidal ideation, perceptions of future suicidal risk, connectedness to others, reasons for living, depression, alcohol use, and self-efficacy. Parents will complete questionnaires that gather demographic information, self-efficacy, baseline means restriction, expectations, hopes, and needs during their visit to PES, assess their child's adaptive functioning and behavioral, social, and emotional adjustment, parent psychiatric history, parental distress, and attitudes about the extent to which seeking mental health treatment is stigmatized. PES clinicians will also administer the Columbia Suicide Severity Rating Scale as part of standard PES practices.
The first phase of intervention (Phase I) involves training clinical staff at PES to implement a new model of service delivery that focuses on the PES visit as an opportunity for crisis intervention for youth and families. The training incorporates best practices in brief crisis-focused interventions in emergency settings. When the provider training is completed, families will receive enhanced usual care by clinical staff along with a toolkit that reinforces evidence-based practices for crisis management such as safety planning, supervision, and monitoring of their at-risk youth. Parents and youth are asked to complete the battery of baseline measures at PES, then an online follow-up survey at 3 days (parents only) and 2 weeks (parents and youth) post discharge. Youth and parents are asked to report on the extent to which they recall their clinician promoting best practice interventions such as safety planning and means restriction during their visit and whether or not they felt their needs were met in PES. Families will also report on barriers accessing outpatient care and need for additional supports. Parents will be asked to report on any means restriction and safety planning activities with their child and whether their child was connected to outpatient services. Youth will be asked to report on the extent to which they feel supported by their families in addition to information about their level of suicide risk.
The second intervention (Phase II) includes the interventions provided during phase I (i.e., enhanced care and toolkit) and caring follow-up contacts for parent participants. Caring contacts post discharge may occur by phone, text, or email. This study will examine the benefit of text messaging contacts in addition to phone contacts in the days and weeks post discharge.
Data from Phase I will be compared to pre-test data obtained at baseline to assess the potential benefits of enhancements to usual care as measured by families' increased abilities to implement safety measures (means restriction, safety plans, risk assessment), support (expressions of caring, modification of expectations), or link their child to outpatient psychiatric treatment. Secondary analyses will explore possible mechanisms of action for family behavior changes (or lack thereof), including levels of parent distress at baseline, parents' stigma regarding receiving psychological services, and markers of the severity of youth psychopathology (i.e., level of suicidality, depression, substance use, functional impairment, and low parental connectedness). Parent ratings of self-efficacy are hypothesized to change with the addition of the interventions during Phase I and Phase II.
- Conditions
- Suicide
- Being tested
- Parent toolkit, Enhanced Care, Caring Follow-Up Messages
- Keywords
- Child, Adoelscent, Crisis Intervention
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent toolkitBehavioural
Also called Toolkit
The parent tookit is a resource that reinforces evidence-based practices for crisis management such as safety planning and means restriction and encourages parents to increase their support, supervision, and monitoring of their at risk youth.
Enhanced CareBehavioural
PES clinical staff will receive training on the best practices in brief crisis-focused interventions in emergency settings with parents and youth.
Caring Follow-Up MessagesBehavioural
Also called Follow-Up
Parents will receive caring contacts via phone, text, or email to provide support, additional education, and problem solving assistance in the days and weeks post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Youth and parents will complete surveys at index PES visit regarding suicide related risk and protective factors. Parents and youth will complete a follow-up survey at 3 days (parents only) and 2 weeks (parents and youth) post discharge. At 3 days and 2 weeks, parents will complete a survey that evaluates adherence to safety recommendations. The 2-week follow-up survey for parents will also re-assess self-efficacy, parental distress, and mental health treatment stigma. The 2-week follow-up survey for youth assesses mood and suicidal thoughts, perceptions of parent support post discharge, and outpatient treatment. It reassesses suicidal risk, depression, connectedness, and alcohol use. |
| Phase I | Experimental | Families will complete baseline measures, and receive enhanced usual care from PES clinical staff during their visit as well as a parent toolkit that reinforces evidence-based practices for crisis management such as safety planning and means restriction and encourages parents to increase their support, supervision, and monitoring of their at risk youth. The same follow-up methodology as in Baseline will be utilized. Receives: Behavioral: Parent toolkit; Behavioral: Enhanced Care |
| Phase II | Experimental | Families will complete baseline measures and receive Phase I interventions (enhanced care and parent toolkit). Parents will receive caring contacts post discharge, which may occur by phone, text, or email. Caring follow-up messages will provide support, additional education, and problem solving assistance. The same follow-up methodology as in Baseline will be utilized. Receives: Behavioral: Parent toolkit; Behavioral: Enhanced Care; Behavioral: Caring Follow-Up Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to safety recommendations
Change in the number of families' engaging in safety recommendations including means restriction in the home, safety planning, and risk assessment as measured by yes/no response.
Measured: Baseline, 3 days, 2 weeks
Access to outpatient mental health services
The number of youth linked to outpatient mental health services including therapy, psychiatry, or a combination.
Measured: 2 weeks
Secondary outcomes (5)
Change in parental self-efficacy: Parent Self-Efficacy Form
Measuring the change in parents' ratings of self-efficacy at baseline and post discharge using the Parent Self-Efficacy Form. This is a 13-item questionnaire developed to assess confidence in promoting safety and talking about suicide with their child. Parents are asked to rate how confident they feel in completing certain actions with their child on a ten-point scale, with 0 being "not confident at all", 5 being "somewhat confident" and 10 being "completely confident." Parents are asked to rate their confidence in performing 13 actions, including asking their child's about his/her mood, identifying suicide warning signs, and completing a safety plan with their child.
Measured: Baseline, 2 weeks
Youth connectedness
Measuring youths' ratings of connectedness at baseline and 2 weeks post discharge using the Parent-Family Connectedness Scale. This is a 13-item self-report measure that assesses the extent to which adolescents feel connected to their parents and family on a 5-point scale. Scale response options include not at all, just a little, somewhat, quite a bit, and very much.
Measured: Baseline, 2 weeks
Parental distress
Measuring parental distress using the Pediatric Inventory for Parents. This questionnaire was developed to measure the stress of caring for a child with an illness and was initially validated among pediatric oncology populations. The measure has been adapted to measure the stress of parenting a child experiencing high suicidality. The instrument asks the respondent to indicate the frequency and difficulty of 34 events over the past 7 days using a 5-point scale. Response options for frequency include never, rarely, sometimes, often, and very often. Response options for difficulty include not at all, a little, somewhat, very much, and extremely. The instrument is scored separately for each of the 3 domains: Communication (range: 8-40), Emotional Distress (range: 15-75), and Role Function (range: 10-50). Higher scores indicate higher levels of distress.
Measured: Baseline, 2 weeks
Youth suicidality
Measuring youth suicidality at baseline and 2 weeks post discharge using the Suicidal Ideation Questionnaire-Junior. The SIQ-JR is a 15-item questionnaire that assesses the frequency of suicidal ideation. It is scored on a 0-6 scale, and a cutoff score of 31 is considered optimal to identify youth at higher risk.
Measured: Baseline, 2 weeks
Parent stigma for receiving psychological help
Measuring parents' attitudes about the extent to which seeking mental health treatment is stigmatized at baseline and 2 weeks post discharge using the Stigma Scale for Receiving Psychological Help. This survey includes 5 items, each rated on a 4-point Likert scale, ranging from 0 (Strongly Disagree) to 3 (Strongly Agree). It has been slightly modified for this study by changing the exclusive focus on "psychological treatment." The word "psychologist" has been replaced by mental health professional.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start10 Sep 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Why it stopped: Enrollment was paused due to COVID-19 restrictions related to recruitment and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Cynthia Ewell Foster, University of Michigan
- Investigators
- Cynthia Ewell Foster, Ph.D., Principal investigator, University of MichiganPatricia Smith, MA, Principal investigator, Michigan Department of Health and Human Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655119
- Sponsor's protocol ID
- HUM00125065
- Other IDs
- 5U79SM061767
- Status last verified
- Apr 2022
- First submitted
- 29 Aug 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Emergency Services Family Support and Follow-Up Program
- ClinicalTrials.gov ID
- NCT03655119
- Acronym / sponsor ID
- HUM00125065
- Conditions
- Suicide
- Keywords
- Child, Adoelscent, Crisis Intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was paused due to COVID-19 restrictions related to recruitment and will not resume.
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Psychiatric Emergency Services (PES) Family Support and Follow-Up Program is a service delivery intervention that utilizes a multi-component approach to enhance usual care provided to youth and families at the University of Michigan Psychiatric Emergency Services in order to promote youth safety and provide support to families following their visit. During the first phase of intervention, families will receive enhanced usual care by clinical staff along with a family toolkit that includes a youth safety plan and written recommendations for safety monitoring and supporting youth during a crisis. During the second phase of intervention, families will receive the interventions provided during the first phase in addition to caring contacts post discharge, which may occur by phone, text, or email. Caring contacts are meant to provide support, additional education, and problem solving assistance.
Detailed description
All participants complete a battery of measures in the waiting room during their PES visit. Youth will complete surveys that collect demographic information, assess current suicidal ideation, perceptions of future suicidal risk, connectedness to others, reasons for living, depression, alcohol use, and self-efficacy. Parents will complete questionnaires that gather demographic information, self-efficacy, baseline means restriction, expectations, hopes, and needs during their visit to PES, assess their child's adaptive functioning and behavioral, social, and emotional adjustment, parent psychiatric history, parental distress, and attitudes about the extent to which seeking mental health treatment is stigmatized. PES clinicians will also administer the Columbia Suicide Severity Rating Scale as part of standard PES practices.
The first phase of intervention (Phase I) involves training clinical staff at PES to implement a new model of service delivery that focuses on the PES visit as an opportunity for crisis intervention for youth and families. The training incorporates best practices in brief crisis-focused interventions in emergency settings. When the provider training is completed, families will receive enhanced usual care by clinical staff along with a toolkit that reinforces evidence-based practices for crisis management such as safety planning, supervision, and monitoring of their at-risk youth. Parents and youth are asked to complete the battery of baseline measures at PES, then an online follow-up survey at 3 days (parents only) and 2 weeks (parents and youth) post discharge. Youth and parents are asked to report on the extent to which they recall their clinician promoting best practice interventions such as safety planning and means restriction during their visit and whether or not they felt their needs were met in PES. Families will also report on barriers accessing outpatient care and need for additional supports. Parents will be asked to report on any means restriction and safety planning activities with their child and whether their child was connected to outpatient services. Youth will be asked to report on the extent to which they feel supported by their families in addition to information about their level of suicide risk.
The second intervention (Phase II) includes the interventions provided during phase I (i.e., enhanced care and toolkit) and caring follow-up contacts for parent participants. Caring contacts post discharge may occur by phone, text, or email. This study will examine the benefit of text messaging contacts in addition to phone contacts in the days and weeks post discharge.
Data from Phase I will be compared to pre-test data obtained at baseline to assess the potential benefits of enhancements to usual care as measured by families' increased abilities to implement safety measures (means restriction, safety plans, risk assessment), support (expressions of caring, modification of expectations), or link their child to outpatient psychiatric treatment. Secondary analyses will explore possible mechanisms of action for family behavior changes (or lack thereof), including levels of parent distress at baseline, parents' stigma regarding receiving psychological services, and markers of the severity of youth psychopathology (i.e., level of suicidality, depression, substance use, functional impairment, and low parental connectedness). Parent ratings of self-efficacy are hypothesized to change with the addition of the interventions during Phase I and Phase II.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Youth and parents will complete surveys at index PES visit regarding suicide related risk and protective factors. Parents and youth will complete a follow-up survey at 3 days (parents only) and 2 weeks (parents and youth) post discharge. At 3 days and 2 weeks, parents will complete a survey that evaluates adherence to safety recommendations. The 2-week follow-up survey for parents will also re-assess self-efficacy, parental distress, and mental health treatment stigma. The 2-week follow-up survey for youth assesses mood and suicidal thoughts, perceptions of parent support post discharge, and outpatient treatment. It reassesses suicidal risk, depression, connectedness, and alcohol use. |
| Phase I | Experimental | Behavioral: Parent toolkit, Behavioral: Enhanced CareFamilies will complete baseline measures, and receive enhanced usual care from PES clinical staff during their visit as well as a parent toolkit that reinforces evidence-based practices for crisis management such as safety planning and means restriction and encourages parents to increase their support, supervision, and monitoring of their at risk youth. The same follow-up methodology as in Baseline will be utilized. |
| Phase II | Experimental | Behavioral: Parent toolkit, Behavioral: Enhanced Care, Behavioral: Caring Follow-Up MessagesFamilies will complete baseline measures and receive Phase I interventions (enhanced care and parent toolkit). Parents will receive caring contacts post discharge, which may occur by phone, text, or email. Caring follow-up messages will provide support, additional education, and problem solving assistance. The same follow-up methodology as in Baseline will be utilized. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Presenting to U-M Psychiatric Emergency Services
- Experiencing suicide-related concerns
Key exclusion criteria (6 listed)
- Do not speak English
- Currently experiencing psychosis
- Currently intoxicated
- Cognitively impaired
- Currently experiencing severe aggression or agitation
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 |
|---|---|---|
| Parent toolkitAlso: ToolkitThe parent tookit is a resource that reinforces evidence-based practices for crisis management such as safety planning and means restriction and encourages parents to increase their support, supervision, and monitoring of their at risk youth. | Behavioural | Phase I, Phase II |
| Enhanced CarePES clinical staff will receive training on the best practices in brief crisis-focused interventions in emergency settings with parents and youth. | Behavioural | Phase I, Phase II |
| Caring Follow-Up MessagesAlso: Follow-UpParents will receive caring contacts via phone, text, or email to provide support, additional education, and problem solving assistance in the days and weeks post-discharge. | Behavioural | Phase II |
Primary outcome
Change in adherence to safety recommendations
Time frame: Baseline, 3 days, 2 weeks
Change in the number of families' engaging in safety recommendations including means restriction in the home, safety planning, and risk assessment as measured by yes/no response.
Access to outpatient mental health services
Time frame: 2 weeks
The number of youth linked to outpatient mental health services including therapy, psychiatry, or a combination.
5 secondary outcomes
Change in parental self-efficacy: Parent Self-Efficacy Form
Time frame: Baseline, 2 weeks
Youth connectedness
Time frame: Baseline, 2 weeks
Parental distress
Time frame: Baseline, 2 weeks
Youth suicidality
Time frame: Baseline, 2 weeks
Parent stigma for receiving psychological help
Time frame: Baseline, 2 weeks
Results and safety
The study was stopped early (reason given: Enrollment was paused due to COVID-19 restrictions related to recruitment and will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Suicide
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
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.
Cynthia Ewell Foster, Ph.D. principal investigator
University of Michigan
Patricia Smith, MA principal investigator
Michigan Department of Health and Human Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent toolkit, Enhanced Care and Caring Follow-Up Messages in people with Suicide, run by University of Michigan at 1 site in United States.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Enrollment was paused due to COVID-19 restrictions related to recruitment and will not resume.). Results are not available in the source record.
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?
Change in adherence to safety recommendations (time frame: Baseline, 3 days, 2 weeks). 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?
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 14 Apr 2022.