Clinical trial NCT03655119: PES Family Support and Follow-Up Program
Official title: Psychiatric Emergency Services Family Support and Follow-Up Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicide
Keywords: Child
Adoelscent
Crisis Intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2018-08-31
Enrollment: 229
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in adherence to safety recommendations
timeFrame: Baseline, 3 days, 2 weeks
measure: Access to outpatient mental health services
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in parental self-efficacy: Parent Self-Efficacy Form
timeFrame: Baseline, 2 weeks
measure: Youth connectedness
timeFrame: Baseline, 2 weeks
measure: Parental distress
timeFrame: Baseline, 2 weeks
measure: Youth suicidality
timeFrame: Baseline, 2 weeks
measure: Parent stigma for receiving psychological help
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Psychiatric Emergency Services
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cynthia Ewell Foster, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Department of Health and Human Services
name: Patricia Smith, MA
role: PRINCIPAL_INVESTIGATOR
References: