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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in United States

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 groups in NCT03655119
Study groupRoleWhat they receive
BaselineNo interventionYouth 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 IExperimentalFamilies 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 IIExperimentalFamilies 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted31 Aug 2018
  2. Study start10 Sep 2018
  3. Primary completion11 Mar 2020
  4. Study completion11 Mar 2020

Why it stopped: Enrollment was paused due to COVID-19 restrictions related to recruitment and will not resume.

Resources

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)
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

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.

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