PES Family Support and Follow-Up Program

Sponsor
University of Michigan (Other)
Overall Status
Terminated
CT.gov ID
NCT03655119
Collaborator
Michigan Department of Health and Human Services (Other), Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed)
229
1
3
18
12.7

Study Details

Study Description

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
  • Behavioral: Parent toolkit
  • Behavioral: Enhanced Care
  • Behavioral: Caring Follow-Up Messages
N/A

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

Study Type:
Interventional
Actual Enrollment :
229 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 :
Sep 10, 2018
Actual Primary Completion Date :
Mar 11, 2020
Actual Study Completion Date :
Mar 11, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Follow-Up
  • Outcome Measures

    Primary Outcome Measures

    1. Change in adherence to safety recommendations [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Psychiatric Emergency Services Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan
    • Michigan Department of Health and Human Services
    • Substance Abuse and Mental Health Services Administration (SAMHSA)

    Investigators

    • Principal Investigator: Cynthia Ewell Foster, Ph.D., University of Michigan
    • Principal Investigator: Patricia Smith, MA, Michigan Department of Health and Human Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cynthia Ewell Foster, Clinical Assistant Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT03655119
    Other Study ID Numbers:
    • HUM00125065
    • 5U79SM061767
    First Posted:
    Aug 31, 2018
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cynthia Ewell Foster, Clinical Assistant Professor, University of Michigan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2022