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PES Family Support and Follow-Up Program

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ClinicalTrials.gov Identifier: NCT03655119
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Michigan Department of Health and Human Services
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Cynthia Ewell Foster, University of Michigan

Brief 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 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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Parent toolkit Behavioral: Enhanced Care Behavioral: Caring Follow-Up Messages Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Psychiatric Emergency Services Family Support and Follow-Up Program
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Baseline
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.
Experimental: Phase I
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.
Behavioral: Parent 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.
Other Name: Toolkit

Behavioral: Enhanced Care
PES clinical staff will receive training on the best practices in brief crisis-focused interventions in emergency settings with parents and youth.

Experimental: Phase II
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.
Behavioral: Parent 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.
Other Name: Toolkit

Behavioral: Enhanced Care
PES clinical staff will receive training on the best practices in brief crisis-focused interventions in emergency settings with parents and youth.

Behavioral: Caring Follow-Up Messages
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.
Other Name: Follow-Up




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in parental self-efficacy: Parent Self-Efficacy Form [ Time Frame: Baseline, 2 weeks ]
    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.

  2. Youth connectedness [ Time Frame: Baseline, 2 weeks ]
    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.

  3. Parental distress [ Time Frame: Baseline, 2 weeks ]
    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.

  4. Youth suicidality [ Time Frame: Baseline, 2 weeks ]
    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.

  5. Parent stigma for receiving psychological help [ Time Frame: Baseline, 2 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presenting to U-M Psychiatric Emergency Services
  • Experiencing suicide-related concerns

Exclusion Criteria:

  • Do not speak English
  • Currently experiencing psychosis
  • Currently intoxicated
  • Cognitively impaired
  • Currently experiencing severe aggression or agitation
  • Unaccompanied by parent/legal guardian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655119


Contacts
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Contact: Cindy Ewell Foster, Ph.D. 734-936-4955. cjfoster@med.umich.edu
Contact: Christina Magness, LMSW cmagness@med.umich.edu

Locations
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United States, Michigan
University of Michigan Psychiatric Emergency Services Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cynthia Ewell Foster, Ph.D.         
Principal Investigator: Cynthia Ewell Foster, Ph.D.         
Sponsors and Collaborators
University of Michigan
Michigan Department of Health and Human Services
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
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Principal Investigator: Cynthia Ewell Foster, Ph.D. University of Michigan
Principal Investigator: Patricia Smith, MA Michigan Department of Health and Human Services

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Responsible Party: Cynthia Ewell Foster, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03655119     History of Changes
Other Study ID Numbers: HUM00125065
5U79SM061767 ( U.S. SAMHSA Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia Ewell Foster, University of Michigan:
Child
Adoelscent
Crisis Intervention

Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms