NCT03655119

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

August 29, 2018

Last Update Submit

April 6, 2022

Conditions

Keywords

ChildAdoelscentCrisis Intervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 weeks

Secondary Outcomes (5)

  • Change in parental self-efficacy: Parent Self-Efficacy Form

    Baseline, 2 weeks

  • Youth connectedness

    Baseline, 2 weeks

  • Parental distress

    Baseline, 2 weeks

  • Youth suicidality

    Baseline, 2 weeks

  • Parent stigma for receiving psychological help

    Baseline, 2 weeks

Study Arms (3)

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.

Behavioral: Parent toolkitBehavioral: 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.

Behavioral: Parent toolkitBehavioral: Enhanced CareBehavioral: Caring Follow-Up Messages

Interventions

Parent toolkitBEHAVIORAL

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.

Also known as: Toolkit
Phase IPhase II
Enhanced CareBEHAVIORAL

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

Phase IPhase II

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.

Also known as: Follow-Up
Phase II

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Psychiatric Emergency Services

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Cynthia Ewell Foster, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Patricia Smith, MA

    Michigan Department of Health and Human Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

September 10, 2018

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations